:

Purpose:

Support the Pharmacovigilance function by performing PADER-related activities, safety data review, reconciliation, regulatory compliance activities, and coordination with internal and external stakeholders to ensure accurate and timely pharmacovigilance activities deliverables

Position / Job Title:

Sr. Officer

Department:

Corporate Quality Assurance (CQA)

Reporting To:

Manager CQA (PV)

Location:

Thane, Mumbai

Years of Experience:

3 – 5 years

Dosage Form:

All applicable dosage forms (Oral solid, Nasal, Liquid oral, Topical, Injectable)

Job Responsibilities / Deliverables:

PADER Review:

- Review PADERs prepared by internal teams or PV service providers for completeness, accuracy, consistency, and regulatory compliance
- Review case line listings, CIOMS/ICSR data, narrative summaries, serious/non-responsible cases, and relevant safety information included in PADERs
- Verify reporting period, data lock point, product/strength, indication, country, and case counts against source PV data
- Review aggregate safety information, including 15-day alert reports, serious and unexpected cases, literature cases, medication errors, product quality complaints with adverse events, and other relevant safety information, as applicable
- Review PADER sections covering changes in labeling, safety signals, actions taken for safety reasons, and relevant literature information

ICSR / Case Management Oversight:

- Review and oversight of individual case safety reports received from various sources
- Review case information for completeness, seriousness, expectedness, causality, listedness, and reportability




- Monitor case processing timelines and follow up with PV service providers for pending or overdue cases

Safety Data Reconciliation:

Perform or coordinate reconciliation between PV and other relevant company functions, including;

Product Quality Complaints

Medical Information

Regulatory Affairs

Customer complaints

Other safety data issues

Track reconciliation discrepancies through investigation and closure

Regulatory Reporting & Compliance:

- Maintain working knowledge of applicable US FDA and other relevant regulatory pharmacovigilance requirements
- Track regulatory reporting calendars and ensure timely completion of assigned deliverables
- Maintain evidence of regulatory submissions, acknowledgements, correspondence, and follow-up

PV Agreements & Documentation:

- Support implementation and maintenance of Safety Data Exchange Agreements (SDEAs) and other PV-related agreements.
- Coordinate with relevant functions for collection and reconciliation of information required under SDEAs
- Maintain PV records, trackers, correspondence, review checklists, and supporting documentation
- Support preparation and maintenance of product-specific PV documentation, where applicable

Qualifications & Pre-Requisites:

- Bachelor of Pharmacy / Master of Pharmacy / Pharm D. / B.Sc. / M.Sc. in Pharmacy or Life Science
- Practical experience in PADER preparation / review. Relevant experience in pharmacovigilance / drug safety, preferably with pharmaceutical manufacturer or PV service provider supporting Mah activities. Familiarity with safety databases such as Argus, ArisG, Veeva Safety, or equivalent is desirable

Additional notes:

It would require travelling across Rubicon sites during various regulatory / customer audits at manufacturing sites.

📌 Senior Officer (India)
🏢 Rubicon Research
📍 India