Location:
xxxxx | Employment Type: Full‑time |

Experience:
10‑18 years

Key Responsibilities
• Lead design, implementation, and maintenance of the Pharmacovigilance Quality Management System (QMS) to meet global regulatory expectations.
• Ensure continuous compliance with PV regulations, including PSMF, SDEA, and other regional requirements.
• Oversee preparation and submission of PV compliance reports to agencies (e.g., RBI, FDA, EMA).
• Coordinate and act as primary auditor for internal/external regulatory inspections and audits.
• Draft, review, and update legal and commercial contracts related to PV activities, ensuring risk mitigation.
• Drive CAPA investigations for quality gaps, track remediation progress, and report status to senior leadership.
• Partner with finance, clinical, and corporate affairs teams to embed PV quality metrics into enterprise risk and compliance dashboards.
• Provide training and mentorship on QMS, ASQ/IRCA standards, and Argus (or equivalent) system usage.
• Manage end‑to‑end recruitment and onboarding of PV QA specialists, ensuring competence and regulatory fit.
• Supply accurate PV cost, budget, and compliance data to Finance and Reporting Managers for periodic reviews.
• Conduct periodic internal audits, generate findings, and lead corrective‑action implementation.




• Compile and present PV quality performance reports to the General Manager / VP of Finance & Accounting.
• Align PV QA activities with broader corporate governance, security standards (PCI‑DSS, ISO‑27001, SSAE‑18) and enterprise risk frameworks. Required Qualifications
• 10‑18 years of experience in Pharmacovigilance, with ≥5 years in a QA or compliance leadership role.
• Deep knowledge of global PV regulations, PVQA processes, PSMF, SDEA, and inspection expectations.
• Proven track record managing QMS, CAPA, and audit programs in a regulated life‑science environment.
• Hands‑on expertise with Argus, ArisG, or comparable PV safety databases.
• Certifications such as ASQ Certified Quality Auditor, IRCA Certified Auditor, or equivalents preferred.
• Ability to draft and review legal/commercial contracts, compliance policies, and corporate advisory documents.
• Solid analytical and report‑writing skills; experience delivering high‑quality compliance and financial impact reports to senior leadership.
• Experience collaborating with finance, clinical, and corporate affairs teams on M&A;, fund‑raise, and financial reporting activities.
• Excellent communication and stakeholder‑management skills; comfortable presenting to board directors and investors. Preferred Education
• MBA, PhD, or advanced degree in Pharmacy, Life Sciences, or a related discipline.

📌 Lead Pharmacovigilance Quality Assurance (Mumbai)
🏢 Alkem Laboratories
📍 Mumbai