Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Section Head Pharmacovigilance Risk Management Responsibilities include

Strategic Leadership in Safety Surveillance

Oversee proactive and continuous evaluation of clinical and postmarketing safety data across the portfolio.

Drive strategic initiatives to identify emerging safety signals, assess trends, and manage known risks at a portfolio level.

Establish surveillance frameworks and KPIs to ensure robust signal detection and risk mitigation.

Signal Management Oversight

Lead and govern the endtoend signal management lifecycle across therapeutic areas.

Chair signal review boards and ensure timely escalation and resolution of critical safety issues.

Align signal prioritization with global safety strategy and regulatory expectations.

Risk Management Strategy

Architect and oversee the development of comprehensive risk management plans RMPs for all marketed and investigational products.

Evaluate effectiveness of risk minimization measures and drive continuous improvement.

Interface with global stakeholders to harmonize risk strategies across regions.

Regulatory Compliance Safety Submissions

Accountable for the quality and timeliness of DSURs, PBRERs, RMPs, and safety responses submitted to health authorities.

Lead crossfunctional safety governance to ensure regulatory alignment and audit readiness.

Serve as final signatory for safety deliverables and regulatory correspondence.

Clinical Development Safety Leadership

Provide strategic safety input into clinical development plans, study protocols, and safety monitoring strategies.

Represent safety in global development teams and ensure integration of safety considerations into clinical trial design.

Lead safety review committees and contribute to gonogo decisions for clinical programs.

CrossFunctional and External Representation

Represent the pharmacovigilance function in senior leadership forums, regulatory authority meetings, and external advisory boards.

Influence crossfunctional decisionmaking by integrating safety insights into medical, regulatory, and commercial strategies.

Health Authority Engagement

Lead interactions with global health authorities on safety matters, including inspections, inquiries, and advisory meetings.

Serve as company spokesperson on product safety profiles and risk mitigation strategies.

Process Excellence and Compliance

Drive continuous improvement in pharmacovigilance processes, SOPs, and systems.

Ensure compliance with global PV regulations and internal standards.

Lead audit preparation and corrective action planning postinspection.

Team Leadership and Capability Building

Manage and develop a team of safety specialists and managers.

Foster a highperformance culture focused on scientific rigor, compliance, and innovation.

Champion training programs and succession planning within the safety organization.