Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 5000 Associates from 27 different nationalities globally. We have 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacturing and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines.

The company has successfully created an integrated multi-technology capability to manufacture all types of dosage forms including sterile injectable and lyophilized products. Highly skilled technicians operate 12 manufacturing facilities that are US FDA, UK MHRA and EMEA compliant sites in India, the US and Europe. It is with immense joy and pride we share with you that Wockhardt Group has won 3 awards in the Outstanding Place To Work contest.

We have been recognized by renowned institutions worldwide for our aim to provide quality healthcare, including the Europe Business Assembly, Oxford, Great Britain for being the `Best Enterprise. In the past two years, Wockhardt has won 109+ Awards at National & International level, and the number is still increasing!

We have a requirement of Lead Medical monitor in our HO in BKC.

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 DE challenge/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 specialisation 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.

If you are interested in exploring this opportunity kindly share your updated resume on this mail i'd [email protected] & [email protected]

📌 Lead medical monitor (Mumbai)
🏢 Wockhardt
📍 Mumbai