Indira Penemetcha
Bangalore
Summary
Dynamic Principal Safety and PV Specialist at Syneos Health with expertise in pharmacovigilance and aggregate report writing. Proven track record in quality review and team management, ensuring compliance and timely reporting. Adept at cross-functional collaboration and training, driving excellence in safety data management and enhancing team performance.
Overview
13
13
years of professional experience
Work History
<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul>
Syneos Health
Bangalore
07.2021 - Current
- - Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.
- - Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.
- - Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.
- - Prepared and Performed QC of the trackers for RSI project.
- - Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.
- - Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints
- - Responsible for reviewing the SOPs, job aids as per program specific requirements.
- - Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.
- - Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.
- - Exhibiting a growing awareness of program strategy and thinking capability alongside independence.
- - Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.
- - Providing standards for gathering information for use in trend analysis.
- - Involved in people development in partnership with PDG leads.
- - Ensuring that all training (internal training and client training) are successfully completed in a timely manner.
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Involved in the preparation of PSUR and PBRER reports and performed quality check of the line listings acquired from the safety database for aggregate reporting.</li><li>- Involved in development, screening and review of scientific literature search.</li><li>- Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Acted as a subject matter expert and help the team members with day-to-day trouble shooting activities</li><li>- Assisted the manager in work allocation, compiling and reporting the program completion reports on timely basis</li><li>- Demonstrated determination and applied creativity in identifying and analyzing tasks and data</li><li>- Managed own workload to ensure delivery of agreed milestones</li><li>- Lead or participated in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Maintained and presented Program Tracker at internal meetings as required</li><li>- Delivered presentations, written reports and generate minutes to meetings as required by the business.</li></ul>
Syneos Health
Bangalore
04.2018 - 07.2021
- - Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c
- - Involved in the preparation of PSUR and PBRER reports and performed quality check of the line listings acquired from the safety database for aggregate reporting.
- - Involved in development, screening and review of scientific literature search.
- - Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.
- - Acted as a subject matter expert and help the team members with day-to-day trouble shooting activities
- - Assisted the manager in work allocation, compiling and reporting the program completion reports on timely basis
- - Demonstrated determination and applied creativity in identifying and analysing tasks and data
- - Managed own workload to ensure delivery of agreed milestones
- - Lead or participated in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints
- - Maintained and presented Program Tracker at internal meetings as required
- - Delivered presentations, written reports and generate minutes to meetings as required by the business.
<ul><li>- Involved in end-to-end case processing which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Syneos Health
Bangalore
05.2016 - 03.2018
- - Involved in end-to-end case processing which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c
- - Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management
- - Systematically reviewed other's work (both within own team, and in other PV teams)
- - Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.
- - Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Bioclinica
Bangalore
01.2015 - 04.2016
- - Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c
- - Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management
- - Systematically reviewed other's work (both within own team, and in other PV teams)
- - Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.
- - Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Bioclinica
Bangalore
10.2012 - 01.2015
- - Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c
- - Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management
- - Systematically reviewed other's work (both within own team, and in other PV teams)
- - Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.
- - Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li></ul>
Syneos Health
Bangalore
08.2012 - 10.2012
- - Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c
- - Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management
Education
Masters - Pharmacy
India
India01.2010
Bachelor - Pharmacy
India
India01.2008
Skills
- Pharmacovigilance (PV)
- Aggregate Report Writing (PADER, DSUR, PBRER, PSUR)
- Case Processing (Aris G, Argus)
- Signal Detection & Risk Management Plan
- Quality Review (QR) & Quality Control (QC)
- Literature Screening & Review
- Regulatory Compliance
- Project & Team Management
- SOP & Job Aid Review
- Cross-functional Collaboration
- Safety Database Management
- Training & Mentoring
- Medical Writing
- Good Documentation Practices
- Client Communication
Languages
English - Speaking, Reading, Writing, - Native, Telugu - Speaking, Reading, Writing
Accomplishments
- Designed and Implemented Quantitative QC Checklists for Aggregate Reports, including PADERs, PBRERs, and DSURs, ensuring objective, measurable quality assessments across deliverables.
- Quality Lead since the inception of the Aggregate Report Project, with a proven track record of consistently surpassing Quality KPIs, reflecting high standards in deliverable accuracy, compliance, and reviewer efficiency.
- Recognized as Best QC’er multiple times in Case Processing for accuracy, attention to detail, and adherence to timelines.
- Delivered a Seminar on Pharmacovigilance at a leading pharmacy college, enhancing student awareness and interest in drug safety careers.
Languages
Telugu
First Language
English
Advanced (C1)
C1
Hindi
Beginner
A1
Timeline
<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul>
Syneos Health
07.2021 - Current
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Involved in the preparation of PSUR and PBRER reports and performed quality check of the line listings acquired from the safety database for aggregate reporting.</li><li>- Involved in development, screening and review of scientific literature search.</li><li>- Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Acted as a subject matter expert and help the team members with day-to-day trouble shooting activities</li><li>- Assisted the manager in work allocation, compiling and reporting the program completion reports on timely basis</li><li>- Demonstrated determination and applied creativity in identifying and analyzing tasks and data</li><li>- Managed own workload to ensure delivery of agreed milestones</li><li>- Lead or participated in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Maintained and presented Program Tracker at internal meetings as required</li><li>- Delivered presentations, written reports and generate minutes to meetings as required by the business.</li></ul>
Syneos Health
04.2018 - 07.2021
<ul><li>- Involved in end-to-end case processing which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Syneos Health
05.2016 - 03.2018
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Bioclinica
01.2015 - 04.2016
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li><li>- Systematically reviewed other's work (both within own team, and in other PV teams)</li><li>- Acted as a subject matter expert and helped the team members with day to day trouble shooting activities.</li><li>- Assisted the Program Lead or Team Lead in compiling and reporting the program completion reports on a timely basis.</li></ul>
Bioclinica
10.2012 - 01.2015
<ul><li>- Involved in end-to-end case processing in Aris G database which includes triage, data entry, quality review and submission of cases received from different sources e.g Spontaneous, clinical trial, literature, solicited e.t.c</li><li>- Created error-free reports and other outputs as per defined specifications to ensure timely reporting of assigned job to program management</li></ul>
Syneos Health
08.2012 - 10.2012
Masters - Pharmacy
India
Bachelor - Pharmacy
India