Senior Officer

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)

PADER Review

Job Responsibilities / Deliverables:

• 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-serious 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.