Pharmacovigilance Manager

Position Summary

Reporting to the Chief Medical Officer, the Pharmacovigilance Scientist (M.D) will manage all activities related to the performance of drug safety at the company. The ultimate objective is to ensure that patients, caregivers, investigators, site staff, and the clinical development team have the most up-to-date insights and information about the safety of the company’s products and the course of action to take should concerns about patient safety arise in clinical trials.

The Pharmacovigilance Scientist (M.D.) will be responsible for ensuring:

• Leading and overseeing all activities required to ensure the safety of patients participating in clinical trials and exposed to the company’s products.
• Ensuring development and completion of the timely delivery of all required drug safety content and documents in compliance with regulatory authorities.
• Implementing the most recent and up-to-date drug safety standards, techniques, and regulations throughout the company’s portfolio of PV activities.
• Having procedures in place for execution should concerns about patient safety arise.
• Proactively integrating drug safety into drug development activities.

Position Responsibilities

• Design and perform analyses of safety information for signal detection.
• Manage the interface with drug safety meetings (PV team, DSMB/DMC, and SAC meetings).
• Maintain a program plan of all activities and deliverables related to drug safety.
• Maintain a central repository for all matters related to drug safety.
• Manage the external PV services provider and ensure the timely execution of contracted activities.
• Set up procedural standards for the conduct of PV activities.
• Ensure that any PV Agreements/Safety Data Exchange Agreements with business partners comply with PV standards and are implemented and followed.
• Monitor compliance with regulatory and company standards for safety data management.
• Conduct root cause analysis of procedural deviations and implement CAPAs as required.
• Maintain records of PV activities for regulatory auditors.
• Support internal PV audits and regulatory inspections.
• Author, coordinate, and review PV-related documents including periodic reports (e.g., DSURs), SMPs, SAE reconciliation plans, RMPs, and RSIs.
• Educate the organization on critical developments and regulatory guidance related to drug safety (FDA, EMA, MHRA, PMDA, and others, where necessary).
• Represent drug safety in product team meetings and all activities where drug safety is critical to the success of the company and its products.
• Actively pursue continuous improvement of the PV system, maintain up-to-date knowledge of international PV requirements, and complete assigned training on time.

Education and Experience

• Relevant advanced degree (e.g., MD).
• Minimum of 7-10 years of relevant experience in pharmacovigilance, drug safety, regulatory affairs, or clinical trials.
• Demonstrated experience in key activities and responsibilities for the role.

Technical Skills / Core Competencies

• Strong analytical skills.
• Attention to detail.
• Excellent written and verbal communication.

Physical Requirements

• Onsite work required 4 days per week.