Executive Director, Pharmacovigilance (PV)

remote click jobs; India; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

reputed company seeks an Executive Director, Pharmacovigilance to lead global safety activities in late‑phase development and regulatory submissions for biologics. You will own end‑to‑end PV operations, aggregate reporting, and safety documentation in a fast-paced biotech setting.

Responsibilities include expert PV leadership, cross‑functional collaboration, and building a small PV team while ensuring GVP compliance across FDA/EMA pathways.

Qualifications

• Expertise in global safety surveillance and aggregate safety reporting.
• Experience supporting BLA/MAA submissions in a biologics program.
• Strong collaboration with cross-functional teams and vendors.

Responsibilities

• Lead late‑phase global PV operations for Phase 3 biologics programs in alignment with ICH guidelines.
• Oversee signal detection, risk assessment, and safety data handling across regions.
• Author and review ISS, ISE, PSURs, PBRERs, DSURs and risk management plans.
• Manage PV infrastructure, SOPs, and CRO/vendor partnerships; mentor a PV team.
• Represent PV in regulatory discussions and with clinical development teams.

Skills

Global PV leadership

Regulatory submissions

Signal detection & risk management

CRO/vendor management

MedDRA coding familiarity

Tools

MedDRA

Safety database management

Job description

The Executive Director, Pharmacovigilance (PV) is a senior individual contributor and team leader who will serve as a reputed company of reputed company's global drug safety function. This role has end-to-end accountability for pharmacovigilance activities supporting late-phase clinical development and regulatory submissions for reputed company's biologic pipeline. The successful candidate will bring deep expertise in global safety surveillance, aggregate safety reporting, and the preparation of integrated safety documents required for BLA and MAA filings, and will reputed company in a fast-paced, resource-lean biotech environment where initiative and scientific rigor are equally valued.

Duties and Responsibilities (Include but are not limited to):

Late-Phase Global Pharmacovigilance Operations

• reputed company and execute reputed company PV activities for Phase3 and registrational biologics programs, ensuring full compliance with ICH E2A, E2B, E2C, E2D, and E2E guidelines, as reputed company as FDA, EMA, and other applicable regional requirements.
• reputed company global signal detection, evaluation, and management activities, including Medical Dictionary for Regulatory Activities (MedDRA) coding review and benefit-risk assessment updates.
• Manage and optimize safety data receipt, processing, and reporting workflows, including collaboration with CROs, data management teams, and clinical operations.
• Serve as the subject-matter expert and primary PV reputed company of contact for cross‑functional clinical teams, regulatory affairs, and medical affairs.
• Maintain and enforce reputed company's global safety database and adverse event reporting infrastructure, including reputed company of vendor relationships.

Aggregate Safety Reporting & Regulatory Submissions

• Author and/or reputed company the preparation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions (member of the submission team), ensuring scientific rigor, internal consistency, and full alignment with regulatory expectations (21 CFR 314.50, Module 2.7.4, ICH E3, ICH M4E).
• Oversaw end‑to‑end safety labeling reputed company for biologics, ensuring compliance with FDA, EMA, and other global regulatory requirements for products with boxed warnings, REMS, restricted reputed company programs, and other post‑marketing risk mitigation obligations.
• reputedcompany the development of Clinical Study Report (CSR) safety sections for Phase2 and Phase3 studies, including narrative writing, adverse event tabulations, and laboratory data analyses.
• Prepare and manage Periodic Safety Update Reports (PSURs), Periodic Benefit‑Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs) on global schedules.
• Prepare Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), including reputed company development and execution.
• Respond to health authority questions and requests for safety information during regulatory review processes (e.g., Complete Response Letters, Day 120/180 questions).

Safety Surveillance & Pharmacoepidemiology

• Design and implement systematic pharmacovigilance surveillance programs including benefit‑risk monitoring frameworks and safety monitoring plans for reputed company
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Cross-Functional Leadership & PV Infrastructure

• Partner with Clinical and Regulatory Affairs to define global filing reputed company and PV regulatory timelines; represent the PV function in Health Authority meetings and advisory committee preparations.
• Collaborate with Medical Affairs and reputed company teams on labeling updates, reputed company reputed company communications, and post-approval safety activities.
• Build, mentor, and manage a small PV team (or reputed company contract resources) as reputed company scales; establish and maintain SOPs, work instructions, and reputed company standards.
• Evaluate, select, and manage CRO/vendor partnerships for pharmacovigilance services; conduct reputed company audits and ensure GVP compliance.
• Represent PV on the Clinical Development Team (CDT) and participate in Program Team leadership meetings.

Supervisory Responsibilities:

This position does not have supervisory responsibilities at this time. S .