Lead Medical Monitor

WOCKHARDT

Job Description

Lead Medical Monitor

Department

Pharmacovigilance NCE Unit

Reports To

Head of Medical Affairs

Direct Reports

Medical Monitor(s), NCE Unit

Experience Required

5+ years in Medical Review, with lead exposure

Qualification

MBBS or MD in Pharmacology or Microbiology; antibiotics experience strongly preferred

Location

India - Mumbai

Job Purpose

The Lead Medical Monitor is the senior scientific authority for causality assessment across Wockhardt's NCE portfolio The role ensures that every adverse event is triaged, medically evaluated and consensus-reviewed to a single, globally consistent and medically defensible standard applying WHO-UMC in full alignment with Wockhardt's regulatory obligations to the DCGI in India and the FDA in the USA. The Lead Medical Monitor is also the scientific lead for the NCE Unit's Medical Monitor team, and the first point of medical contact for signal evaluation on assigned products.

Key Responsibilities

Causality Assessment & Medical Review

• Initial Causality Assessment: Perform initial causality and seriousness assessment for every ICSR involving an NCE product, applying WHO-UMC and Adverse Drug Reaction Probability Scale criteria consistently and in parallel with case processing.
• Clinical Review: Review case narratives, clinical history, concomitant medications, laboratory values and dechallenge/rechallenge information to support a medically sound and well-documented causality determination.
• Escalation to Medical Affairs: Escalate complex, ambiguous or high-severity cases to Medical Affairs for consensus review within the agreed internal timeline, ensuring no case is left without a final medical position.
• R&D Consultation: Where causality remains suspected as drug-related following Medical Affairs review, coordinate with the R&D team for final scientific input before the case is closed for submission..
• Three-Way QC Sign-Off: Provide medical sign-off as part of the three-way quality check — Medical Reviewer, QPPV and Head of Department — required before any case proceeds to regulatory submission.
• Methodology Consistency: Support the QPPV and PvPOC in maintaining one consistent causality assessment methodology across every NCE product and every market in which Wockhardt operates.
• Missing Information: Identify cases requiring additional clinical information from the reporter and direct the MR/MSL follow-up process, which requires a minimum of three documented contact attempts (phone, email or equivalent) within a four-day window.
• Therapy-Area Nuance: Ensure product- and therapy-area-specific medical nuance including antibiotic-class adverse event patterns relevant to the NCE portfolio is correctly reflected in every causality assessment.

Signal Detection & Evaluation

• First Medical Point of Contact: Act as the first medical point of contact for potential safety signals arising from ICSRs, literature surveillance or social media monitoring conducted from India.
• Signal Evaluation: Evaluate emerging signals against the full case series and aggregate reporting trends, and escalate validated signals to the PV Governance Council in line with Wockhardt's signal management process.
• Risk Management Input: Contribute medical input into Risk Management Plan updates and labelling change assessments triggered by a validated safety signal.

Regulatory & Systems Compliance

• System Accuracy: Ensure all causality assessments and supporting medical rationale are accurately and promptly entered into the Oracle Argus safety database..
• Documentation Trail: Maintain a complete and defensible documentation trail for every causality decision, in a form suitable for Health Authority inspection or internal audit at any time.

Qualifications & Experience

• MBBS or MD, with a specialization in Pharmacology/ IDD specialist or Microbiology strongly preferred.
• Minimum 5+ years of experience in medical review or pharmacovigilance, including demonstrated exposure to a lead or supervisory capacity.
• Hands-on experience in antibiotics / anti-infective therapy areas strongly preferred, reflecting the therapeutic focus of the NCE portfolio.
• Working knowledge of WHO-UMC causality assessment methodology and the Naranjo Adverse Drug Reaction Probability Scale.
• Familiarity with Oracle Argus or an equivalent pharmacovigilance safety database, and with ICH E2B(R3) data standards.
• Understanding of Indian (DCGI / Schedule Y) and US (FDA) pharmacovigilance regulatory requirements is an advantage.

Reporting Line

• Reports To: Head of Medical Affairs
• Team: Leads Medical Monitor(s) within the NCE Unit; partners closely with Medical Affairs on causality consensus and launch training.