Lead Pharmacovigilance Quality Assurance (PVQA)

Lead Pharmacovigilance Quality Assurance (PVQA)

Alkem Laboratories Ltd.

Location: Mumbai Metropolitan Region
Job type: Full-time

Required skills

accounting
compliance
ARGUS

About the role

Alkem Laboratories Ltd.

Website: alkemlabs.com
Job details:
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.
Strong 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.

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