Rashmita Pant
Towson,MD
Summary
Results-driven pharmacist with 12 years of global experience in Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Proficient in end-to-end Pharmacovigilance operations, ICSR management, aggregate report (PSUR/PBRER, DSUR), Risk management plan, medical device complaint, post-market surveillance, and safety database implementation.
Demonstrated success in audits, CAPAs, vendor management, and Quality Management Systems.
Authorized to work in the United States without sponsorship.
Overview
14
14
years of professional experience
Work History
Pharmacovigilance Manager
Specialised Therapeutics
Singapore And Remote- United States
04.2022 - 01.2025
- Led Pharmacovigilance department, ensuring compliant global operations and regulatory compliance for over 10 products.
- Managed ICSR processing and submissions to meet reporting timelines.
- Handling of Medical device complaint and conducted post-market surveillance in compliance with regulatory requirement.
- Developed SOPs, policies, and training to standardize processes and enhance compliance.
- Authored, and submitted aggregate reports (PSUR/PBRER, DSUR) to meet safety reporting requirements.
- Submitted RMPs and supported signal detection activities to fulfill regulatory safety obligations.
- Reviewed REMS/EU-RMPs to implement localized risk strategies.
- Acted as Primary PV contact for regulators and partners, ensuring effective communication.
- Directed safety database setup, validation, and rollout for operational efficiency.
- Oversaw eight vendors and PVAs/SDEAs to ensure clear responsibilities and timely deliverables.
- Reviewed study protocols/IBs to ensure PV compliance in clinical studies/programs.
- Led audits and regulatory inspections, ensuring compliance with zero critical findings.
PV and MI Operations Specialist 2 (Client: GSK)
IQVIA RDS East Asia
Singapore
03.2019 - 01.2022
- Managed medical inquiries, AEs, and product complaints, ensuring timely reporting.
- Processed spontaneous, literature, and clinical trials study reports (approx. 60 cases/week) to meet timelines.
- Handling of Medical device complaint in compliance with medical device regulatory requirement.
- Collaborated with IT to customize, validate, and implement safety databases.
- Led and mentored team members as a certified QCer, conducting training and quality checks.
- Handled deviations, RCA, and CAPAs (TrackWise) to drive continuous quality improvement.
- Led a medical information project, overseeing inquiry handling, content updates, and client communication.
Quality Systems Specialist
Becton Dickinson Holdings Pte. Ltd.
Singapore
03.2018 - 02.2019
- Led SAP v6.0 implementation for quality processes to streamline documentation and compliance.
- Managed document control, non-conformance, and CAPA to ensure quality system integrity.
- Handled product complaints and investigations to support timely issue resolution.
- Processed Quality Hold Notices to ensure prompt release of held products.
Pharmacovigilance and Regulatory Affairs Specialist
Innokeys Pte. Ltd.
Singapore
02.2017 - 12.2017
- Processed approx. 60 ICSRs/week to ensure timely and compliant case submissions.
- Developed and implemented SOPs and templates to standardize PV best practices.
- Performed QC checks of AEs to ensure accuracy and completeness of reports.
- Submitted CTA and NDA filings to Health Authorities to support product approvals.
Global Pharmacovigilance Scientist (Client: Roche)
Tata consultancy services
Mumbai, India
07.2014 - 06.2016
- Managed global ICSRs and conducted clinical assessments to ensure accurate case evaluation and regulatory compliance.
- Processed approx. 50 cases/week (spontaneous, literature, study) to meet submission timelines.
- Trained and mentored peers in case processing to maintain consistency with SOPs and regulatory standards.
- Performed QC reviews as a certified QCer to ensure data accuracy and completeness.
Corporate Quality Officer
Emcure Pharmaceuticals Pvt. Ltd.
Pune, India
01.2013 - 12.2013
- Reviewed updates from USP, BP, Ph. Eur, and IP to assess changes in monographs and ensure regulatory alignment.
- Prepared and revised specifications, methods of analysis, and Standard Test Procedures to maintain compliance with updated standards.
Quality Assurance Officer
Cipla Ltd
Goa, India
09.2010 - 08.2012
- Managed QMS elements including SOPs, Change Control, Deviations, and CAPA to ensure continuous quality compliance.
- Oversaw manufacturing and packaging QA activities to maintain GMP standards across operations.
- Handled post-approval changes, regulatory approvals, and dossier maintenance to support product lifecycle management.
- Reviewed Technical Agreements to ensure alignment with regulatory and quality requirements.
Education
Master of Science - Pharmacovigilance and Pharmacoepidemiology
University of Bordeaux
09.2024
Bachelor of Pharmacy -
Shivaji University
Kolhapur, India08.2010
Skills
- Pharmacovigilance Operations
- Aggregate Report (DSUR, PSUR, PBRER)
- Risk Management Plans (EU-RMP, REMS)
- PVA/SDEA
- Vendor management
- Safety Databases (ARISg, Argus)
- QMS (SOP, CAPA, RCA, Deviations)
- Inspection Readiness & Audit Compliance
- PV QA and regulatory compliance
- Product complaint and Post-Market surveillance
- Team Leadership
- Cross-Functional Collaboration
Timeline
Pharmacovigilance Manager
Specialised Therapeutics
04.2022 - 01.2025
PV and MI Operations Specialist 2 (Client: GSK)
IQVIA RDS East Asia
03.2019 - 01.2022
Quality Systems Specialist
Becton Dickinson Holdings Pte. Ltd.
03.2018 - 02.2019
Pharmacovigilance and Regulatory Affairs Specialist
Innokeys Pte. Ltd.
02.2017 - 12.2017
Global Pharmacovigilance Scientist (Client: Roche)
Tata consultancy services
07.2014 - 06.2016
Corporate Quality Officer
Emcure Pharmaceuticals Pvt. Ltd.
01.2013 - 12.2013
Quality Assurance Officer
Cipla Ltd
09.2010 - 08.2012
Master of Science - Pharmacovigilance and Pharmacoepidemiology
University of Bordeaux
Bachelor of Pharmacy -
Shivaji University