Harsha Pande
Pune
Summary
Seeking position in an organization where I can apply my thoughts and skills for the development of the organization as well as my personal growth.
Registered pharmacist with 12 years of work experience. Worked in the pharmacovigilance / Regulatory team for Drug / Device / Animal safety. Worked with ArisG / Argus /Veeva safety /LSIT /LSMV databases. Experience in QI, CAPA, Power BI, Third party QR.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Sr. Safety Associate
Syneos Health
06.2015 - 04.2019
- Process adverse event reports received from sites/reporters
- Perform QC review of completed individual and periodic safety reports
- Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information
- Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter
- Engage with the Site Monitors to ensure follow up information is obtained from site effectively
- Foster constructive and professional working relationships with all project team members, internal and external
- File documents according to project specific requirements (electronically or in hard copy as applicable)
- Ensure case files are compliant with SOPs
- Distribute safety data reports to other Sr
- Safety Associate peer and Medical Monitor for review
- Distribute safety data reports to clients and other relevant parties
- Responsible for ensuring project deliverables are completed on time and with high quality
- Ensure compliance with company policies, procedures, and standards
- Participate in the development of safety SOPs and Operating Guides
- Mentor and train other associates on processes regarding case processing
- Communicate with other departments and clients as directed by project lead to ensure compliance with safety and PV SOP’s
- Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
Quality Reviewer for ICSR’s
Cognizant Technological Solutions
03.2013 - 06.2015
- Performing the quality review of post marketing oncology and anti-inflammatory cases
- Develop knowledge and skills in reviewing multiple case outputs to support Surveillance activities
- Reading the narrative and identifying the events, if missing coding the events accordingly
- Conduct the calibration session with the team on ongoing basis
- Be fully competent to perform all steps within the case-handling process from triage through to QRE for cases of all levels of business risk
- Performing follow with the physician’s for further follow up for oncology cases.
Quality Reviewer for ICSR’s
TCS
07.2012 - 03.2013
- Performing the quality review of post marketing oncology and anti-inflammatory cases
- Handle the quality check process after completing the data entry
- Conduct the calibration session with the team on ongoing basis
- Attend the internal call with SME
- Help to resolve the query related with the case processing
- Be fully competent to perform all steps within the case-handling process from triage through to QRE for cases of all levels of business risk
- Having a broad understanding of Surveillance activities and the impact an individual case or group of cases can have on product labeling
- Contribute to the development and implementation of new safety-related systems, processes and procedures within the Region
- Represent the Region on specific Patient Safety Process Teams
- Ensure the development and provision of training within the Region
- Deliver scientific and surveillance contributions for one or more products in accordance with the Clinical Project Operating Model
- Support a performance-driven culture
- Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
- Develop knowledge and skills in reviewing multiple case outputs to support Surveillance activities
- Reading the narrative and identifying the events, if missing coding the events accordingly.
ICSR case processor
TCS
10.2011 - 06.2012
- Be fully competent to perform all steps within the case-handling process from triage to case submission to regulatory for cases
- Having a broad understanding of Surveillance activities and the impact an individual case or group of cases can have on product labeling
- Provide scientific and technical contribution to the maintenance of one or more of the Support Section activities within the process
- Reading the narrative and identifying the events, if missing coding the events accordingly
- Process the cases according to the internal timelines and route the case for quality review
- Accepting the cases from the queue and performing the triage by coding the events according to the verbatim
- Writing the narrative of the case according to the case type and writing the company summary in support of the product to the serious cases
- Coding of events using Enterprise imaging and triaging of unstructured documents and coding the events accordingly
- Performed as a backup triage in the process that included Enterprise imaging and IRPC.
Sr. Safety and PV Specialist (Sr. Safety Associate-2)
Syneos Health
04.2019
- Serving as a Safety and Pharmacovigilance (SPVG) Subject Matter Expert (SME) within the Company
- Provides guidance and expertise for all tasks associated with Individual Case Safety Report (ICSR) processing and provides training and mentoring for less experienced associates
- Participates in the development and review of departmental policies and procedures as controlled documents
- Analyses processes and develop strategies to increase efficiency and optimize resources
- Ensures compliance with related regulations and resolves complex issues through in-depth evaluation as an SME
- Continually seeks out ways to enhance customer service experience both internally and externally
- Works independently to oversee day to day Safety and Pharmacovigilance (SPVG) activities on assigned projects/programs
- Exercises independent judgement to troubleshoot and resolve project issues and to identify areas for improvement
- Develops innovative solutions to meet unique, client-specific requirements
- Presents at client/investigator meetings
- Develops training materials, conducts training presentations and on-the-job-training for appropriate departmental teams
- Provides expertise for procedures and QI support
- Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs)
- Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes
- Participate in audits/inspections as the SPVG SME
- Maintains understanding and compliance with SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, study/program plans and the drug development process.
Education
Bachelor of Pharmacy -
University Department of Pharmaceutical Sciences RTM - Nagpur University
Higher Secondary Education -
Dharampeth science college – Nagpur
Secondary School Education -
Sandipani school – Nagpur
Skills
- Excellent interpersonal and communication skills
- Trainer
- Workflow Management (Case allocation)
- Power BI
- Aris G
- Argus
- LSIT
- LSMV database trained
- Quality Management
- CAPA management
- QI management
- Audit Readiness
- Third party Quality Management
- Able to work independently with effective time management
- Able to work effectively as part of a team
- Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
- Good knowledge of Pharmacovigilance practices
- Knowledge of drug safety and ICH/GCP principles
Certification
- Six Sigma Black Belt.
- PMP Basics.
- Introduction to project management (CAPM)
Disclaimer
All the details furnished above are true to the best of my knowledge and belief.
Timeline
Sr. Safety and PV Specialist (Sr. Safety Associate-2)
Syneos Health
04.2019
Sr. Safety Associate
Syneos Health
06.2015 - 04.2019
Quality Reviewer for ICSR’s
Cognizant Technological Solutions
03.2013 - 06.2015
Quality Reviewer for ICSR’s
TCS
07.2012 - 03.2013
ICSR case processor
TCS
10.2011 - 06.2012
Bachelor of Pharmacy -
University Department of Pharmaceutical Sciences RTM - Nagpur University
Higher Secondary Education -
Dharampeth science college – Nagpur
Secondary School Education -
Sandipani school – Nagpur
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