Laxmi Maithili Gajula
PV Professional
Bangalore,KA
Summary
Results driven professional with over 11 years of experience seeking to contribute strategic insight and operational expertise to a forward-thinking organization focused on innovation and growth.
Results-driven scientific professional prepared for Senior Drug Safety Associate role. Extensive experience in pharmacovigilance, ensuring patient safety and regulatory adherence. Focused on collaborative team efforts and delivering reliable outcomes in dynamic settings. Proficient in risk assessment and adverse event reporting.
Overview
13
13
years of professional experience
7
7
years of post-secondary education
2
2
Languages
Work History
Senior Drug Safety Associate II
MMS Holdings Clinical Research Private Limited
02.2024 - Current
- Lead multiple complex narrative writing projects for clinical study report, summary of clinical safety, and integrated safety summary submission
- Lead DSUR and PBRER projects
- Involved in authoring or review of regulatory submission documents such as Periodic and Risk Documents/Aggregate Reports (DSUR, PBRER, PADERS)
- Involved in literature search and summarization of articles
- Involved in preparation of client specific guidance document and template for safety narratives and Aggregate Reports (DSUR, PBRER, PADERS)
- Coordinates with Sponsor PM/POC to develop, define, and negotiate project timelines
- Supports/promotes accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations
- Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers as necessary
- Conduct team huddles and weekly meetings with team, maintaining the records of trainings, internal meeting and client meetings
- Execute Project Management activities such as resource planning, planning activities, allocation of task, tracking, and ensuring high quality of the project deliverable
- Mentor and train new joiners and peer colleagues on safety narratives and aggregate reports (DSUR/PBRER/PADERS)
- Conduct refresher training(s) based on internal QC findings/team needs
- Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and client policies
- Participate in regulatory inspections, internal audits and/or strategic quality initiatives as needed
Senior Drug Safety Associate I
MMS Holdings Clinical Research Private Limited
08.2020 - 01.2024
Technical Specialist Functional (TSF)
MMS Holdings Clinical Research Private Limited
05.2020 - 08.2020
Drug Safety Associate II
MMS Holdings Clinical Research Private Limited
04.2017 - 02.2019
Drug Safety Associate I
MMS Holdings Clinical Research Private Limited
04.2015 - 04.2017
Pharmacovigilance Writer
MMS Holdings Clinical Research Private Limited
11.2013 - 03.2015
Drug Safety Associate
Tata Consultancy Services
08.2012 - 08.2013
- Acknowledging receipt of ICSRs to sender within timelines documented in relevant SOP
- Accountable for sending queries for clarity associated with incoming information if required
- Accountable for performing accurate data capture for individual case safety reports
- Accountable for performing appropriate assessments (including assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements
- Assuring compliance with use of Client Safety database through reference of latest SOPs and relevant manuals
- Responsible for ensuring that individual training records are updated in line with inspection readiness
Education
Bachelor’s Degree - Pharmaceutical Science
Osmania University
01.2007 - 01.2011
Intermediate - BiPC – Biology Physics Chemistry
Board of Intermediate Education - Andhra Pradesh
03.2004 - 03.2006
Board of Secondary Education - undefined
Board of Secondary Education - Andhra Pradesh
03.2003 - 04.2004
Skills
People Management
Project Management
Authoring and quality review of safety narratives
Authoring and quality review of aggregate reports (DSUR/PBRER/PADERS)
Literature search and summarization
Experience in case processing (Argus safety database)
Personal Information
- Date of Birth: 08/14/89
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Affiliations
Registered pharmacist Telangana State Pharmacy council since 2012.
Timeline
Senior Drug Safety Associate II
MMS Holdings Clinical Research Private Limited
02.2024 - Current
Senior Drug Safety Associate I
MMS Holdings Clinical Research Private Limited
08.2020 - 01.2024
Technical Specialist Functional (TSF)
MMS Holdings Clinical Research Private Limited
05.2020 - 08.2020
Drug Safety Associate II
MMS Holdings Clinical Research Private Limited
04.2017 - 02.2019
Drug Safety Associate I
MMS Holdings Clinical Research Private Limited
04.2015 - 04.2017
Pharmacovigilance Writer
MMS Holdings Clinical Research Private Limited
11.2013 - 03.2015
Drug Safety Associate
Tata Consultancy Services
08.2012 - 08.2013
Bachelor’s Degree - Pharmaceutical Science
Osmania University
01.2007 - 01.2011
Intermediate - BiPC – Biology Physics Chemistry
Board of Intermediate Education - Andhra Pradesh
03.2004 - 03.2006
Board of Secondary Education - undefined
Board of Secondary Education - Andhra Pradesh
03.2003 - 04.2004