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-reliable 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 i

📌 Senior Officer (Thane)
🏢 Rubicon Research
📍 Thane