Lead Pharmacovigilance Quality Assurance (PVQA)

Alkem Laboratories Ltd.; Maharashtra; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Alkem Laboratories Ltd. in India seeks an experienced Pharmacovigilance Quality Assurance leader to design, implement, and maintain the QMS to meet global regulatory expectations.

The role oversees PV compliance, audits, CAPA, and contract governance, partnering with finance, clinical, and corporate affairs to embed PV quality metrics into enterprise risk dashboards and reports to senior leadership. Candidates should bring 10–18 years in PV, with at least 5 years in QA leadership, and hands-on

Qualifications

• 10‑18 years of PV experience with ≥5 years in QA/compliance leadership.
• Deep knowledge of global PV regulations, PVQA processes, PSMF and SDEA.
• Proven track record managing QMS, CAPA, and audits in regulated life-science environments.
• Hands‑on expertise with PV safety databases (Argus/ArisG).
• Certifications such as ASQ/IRCA preferred.

Responsibilities

• Lead design, implementation, and maintenance of the PV QMS to meet global regulatory expectations.
• Oversee PV compliance with regulations (PSMF, SDEA) and regional requirements.
• Coordinate submission of PV compliance reports to agencies (RBI, FDA, EMA).
• Act as primary auditor for internal/external regulatory inspections and audits.
• Draft, review, and update PV contracts ensuring risk mitigation.
• Drive CAPA investigations and track remediation for senior leadership.
• Embed PV quality metrics into enterprise risk dashboards with cross-functional teams.
• Provide training on QMS, ASQ/IRCA standards, and PV databases like Argus.
• Manage recruitment and onboarding of PV QA specialists.
• Supply PV cost, budget, and compliance data to Finance and Reporting Managers.
• Conduct internal audits and lead corrective action implementation.
• Present PV quality performance reports to GM/VP Finance & Accounting.
• Align PV QA activities with governance, PCI‑DSS, ISO‑27001 standards.

Skills

PV leadership

QMS management

Regulatory inspections

CAPA investigations

Data analytics

Contract drafting

Stakeholder management

Audit coordination

Education

MBA or PhD in Pharmacy or Life Sciences

Tools

Argus

ArisG

Job description

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.