Pratiksha Omkar Ghorpade
Drug Safety Associate
Pune
Summary
A dedicated Drug Safety Associate with 5+ years of experience in pharmacovigilance, case processing, and quality review. Proven expertise in managing Individual Case Safety Reports (ICSRs), MedDRA, WHODD coding, and adhering to global regulatory timelines. Seeking to leverage hands-on knowledge of ICH-GCP, GVP modules, and safety database management in a challenging drug safety role.
Overview
3
3
Languages
2
2
Certifications
9
9
years of professional experience
Work History
Drug Safety Associate II
Qinecsa
12.2021 - 12.2025
- Performed ICSR case Intake, Data Entry, Quality Control (QC) review to ensure accuracy and adherence to global regulatory timelines.
- Strong knowledge of Argus Safety database, MedDRA and WHODD.
- Handled pharmacovigilance mailbox activities.
- Insured timely case submission in compliance with ICH-GCP and GVP guidelines.
Junior Drug Safety Associate
Cognizant Technology Solutions
01.2020 - 11.2021
- Performed case intake, data entry and quality review and ensured adherence to internal SOPs and client requirements.
- Gained strong operational knowledge of Argus Safety database.
Junior Clinical Documentation Management Associate
Inventurus Knowledge Solutions PVT LTD
10.2019 - 01.2020
- Accurately reviewed and audited electronic health records (EHR) to extract critical data points including diagnoses, medications, and surgical histories.
- Verified patient charts against strict institutional guidelines to ensure full compliance with HIPAA regulations and data security standards.
Medical Business Associate - Marketing
GSK Pharmaceutical
09.2018 - 10.2019
- Managed key therapeutic areas (Fortior division) and product portfolios including Augmentin, Calpol, and Neosporin.
- Handled business operations, stockist relationships, and new appointments for the Mira Road & Bhayander territory.
- Organized and conducted Doctor meets and Continuing Medical Education (CME) sessions.
Hospital Pharmacist
B.C.J. and Asha Parekh Hospital
12.2016 - 09.2018
- Managed hospital pharmacy inventory and ensured proper documentation.
- Maintained prescription accuracy and patient data records and Ensured compliance with hospital pharmacy regulations.
Education
Bachelor of Pharmacy -
Mumbai University
Ratnagiri06-2016
HSC -
Mumbai University
Ratnagiri06-2012
SSC -
Konkan Board
Ratnagiri06-2010
Skills
- Pharmacovigilance: ICSR Processing (Intake-triage, Data Entry, Quality Review), MedDRA & WHODD Coding, Narrative Writing
- Regulatory Knowledge: ICH-GCP, Good Pharmacovigilance Practices (GVP), Regulatory Reporting Timelines
Certification
Certification: Good Clinical Practice (GCP) from national institute on Drug Abuse (NIDA) clinical trials network.
Timeline
Drug Safety Associate II
Qinecsa
12.2021 - 12.2025
Junior Drug Safety Associate
Cognizant Technology Solutions
01.2020 - 11.2021
Junior Clinical Documentation Management Associate
Inventurus Knowledge Solutions PVT LTD
10.2019 - 01.2020
Medical Business Associate - Marketing
GSK Pharmaceutical
09.2018 - 10.2019
Hospital Pharmacist
B.C.J. and Asha Parekh Hospital
12.2016 - 09.2018
Bachelor of Pharmacy -
Mumbai University
HSC -
Mumbai University
SSC -
Konkan Board