Pooja Sen
Wellington, Ooty
Summary
More than 13 years of robust experience in drug safety including expertise in managing Individual Case Safety Reports (ICSRs). Proficient in invoicing, forecasting and change in scope planning. Experience in leading audits and managing Corrective And Preventive Actions (CAPAs) to drive quality improvement and regulatory compliance. Expertise in providing guidance and direction to Drug Safety Associates and responsible for providing regular reviews and appraisals for team members. Involved in induction trainings to the new hires and refreshers to the existing team members. Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation). Trained and mentored Drug Safety Associates in various activities of case processing.
Overview
14
14
years of professional experience
Work History
Manager, PV Operations
Parexel International Services India Private Limited, Mohali
04.2024 - Current
- Managing (directing, training, motivating, evaluating) a team of 50+ personnel in pharmacovigilance activities, including guiding employees to use more effective program methodologies and grow in technological and procedural efficiency.
- Proficient in generating accurate and detailed invoices, and ensuring timely submission of invoices to clients.
- Skilled in conducting data analysis, identifying trends, and developing accurate financial forecasts to support project planning and budgeting.
- Proficient in evaluating proposed changes in project scope, assessing their impact, and developing comprehensive change management plans to mitigate risks and ensure successful implementation.
- Leading audits and working collaboratively with cross-functional teams for CAPA management.
- Managing CAPA investigations, utilizing root cause analysis techniques to identify underlying issues and implementing targeted correcive actions to prevent recurrence.
- Liaising with the client for coordination of processing of Individual case safety reports.
- Involved in Business Contingency Planning, Pandemic Planning and Inspection Readiness.
Associate Manager, PV Operations
Parexel International Services India Private Limited
Mohali
01.2022 - 03.2024
- Management Experience: -
Managing (directing, training, motivating, evaluating) the team in pharmacovigilance activities, including guiding employees to use more effective program methodologies and grow in technological and procedural efficiency. - Identifying the team’s training & development needs, designing and developing the appropriate training program and afterwards coordinating appropriate internal training programs.
- Performing reviews for team members and providing appropriate feedback. Identifying and addressing any inter-personal issues within the team and raising the issues with the senior management where required.
- Planning work capacities and managing the workload to ensure compliance with report/case submissions- managing resources and requests for new assignments.
Senior Drug Safety Specialist
Parexel International Services India Private Limited
Mohali
07.2020 - 12.2021
- Experience in management of ICSRs which includes:
Book-in of reports in Safety database/Triage of ICSRs to determine whether they qualify for expedited reporting or not and timelines within which they need to be submitted to regulatory authorities
Data entry of ICSRs in safety database, including determining expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc.), writing case summaries and assessing causalities if required
Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider"
Expertise in managing safety data on various safety databases Argus, Aris G
Maintaining good working knowledge of AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including:
ICH guidelines on safety and efficacy
FDA guidelines
CIOMS
GVP Modules/ New EU PV Legislation
Expertise in report nullification (decision making and processing) and case merging into a ‘Master’ case
Expertise in handling Enterprise Resource and Planning (ERP) tool
Handled Unblinding of Clinical Trial cases after receipt of unblinding information from the client in safety database
Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients' policies
Responding to clients/customers in a timely manner
Literature experience:
Experienced in literature review and validity assessment of literature citations including medical journals abstracts, poster presentation and full literature articles
Expertise in processing of literature cases for more than 10 years including medical journals abstracts, posters and full literature articles in the safety database
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Senior Pharmacovigilance Specialist II
Parexel International Services India Private Limited
Mohali
11.2018 - 06.2020
- Demonstrated high level of initiative and creativity while tackling difficult tasks
- Managed time efficiently in order to complete all tasks within deadlines
- Self-motivated, with strong sense of personal responsibility
Senior Pharmacovigilance Specialist
Parexel International Services India Private Limited
Mohali
04.2015 - 10.2018
- Reviewed, compiled and analyzed data for safety database management
- Supported inspections, visits and audits as well as CAPAs management
Pharmacovigilance Specialist, Pharmacovigilance Analyst, Pharmacovigilance Scientist
Quantum Solutions India
Chandigarh
04.2011 - 03.2015
- Developed strong knowledge of case processing
- Demonstrated quality and team work
- Entered adverse events case reports in database and conducted follow-up
- Reviewed, compiled and analyzed data for safety database management
Junior Resident
Himachal Dental College
Sundernagar
04.2010 - 03.2011
Education
Dentistry
Government Dental College And Hospital
Shimla12th
Maharaja Lakshman Sen Memorial College
Mandi, HP10th -
St. Mary's High School
Skills
- Invoicing
- Forecasting
- Resource and operations management
- Audits and CAPA management
- Employee performance evaluations
- Training
Affiliations
Himachal Pradesh State Dental Council
Languages
- English: Fluent
- Hindi: Fluent
Accomplishments
* Collaborated with AI labs team in the development and implementation of Automated Recon too
*Achieved 100% KPIs by completing the case processing related tasks with accuracy and efficiency.
*Awarded for outstanding performance in 2023 under the Country head recognition program
*Nominated for Outstanding performance in 2020
Timeline
Manager, PV Operations
Parexel International Services India Private Limited, Mohali
04.2024 - Current
Associate Manager, PV Operations
Parexel International Services India Private Limited
01.2022 - 03.2024
Senior Drug Safety Specialist
Parexel International Services India Private Limited
07.2020 - 12.2021
Senior Pharmacovigilance Specialist II
Parexel International Services India Private Limited
11.2018 - 06.2020
Senior Pharmacovigilance Specialist
Parexel International Services India Private Limited
04.2015 - 10.2018
Pharmacovigilance Specialist, Pharmacovigilance Analyst, Pharmacovigilance Scientist
Quantum Solutions India
04.2011 - 03.2015
Junior Resident
Himachal Dental College
04.2010 - 03.2011
Dentistry
Government Dental College And Hospital
12th
Maharaja Lakshman Sen Memorial College
10th -
St. Mary's High School
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