Medical Director of Drug Safety and Pharmacovigilance

Position Summary: The Senior Medical Director of Drug Safety and Pharmacovigilance will lead and oversee all aspects of drug safety and pharmacovigilance activities. This role is critical in ensuring the safety of our products throughout their lifecycle, from clinical development through post-marketing surveillance.

Key Responsibilities:

• Lead the Drug Safety and Pharmacovigilance team, providing strategic direction and oversight.
• Develop and implement pharmacovigilance strategies and risk management plans.
• Ensure compliance with global regulatory requirements and guidelines.
• Oversee the collection, analysis, and reporting of adverse event data.
• Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs.
• Provide medical expertise and safety assessments for clinical trials and marketed products.
• Lead safety signal detection, evaluation, and risk mitigation activities.
• Represent the company in interactions with regulatory authorities and external stakeholders.
• Develop and deliver training programs on drug safety and pharmacovigilance.
• Stay current with industry trends and advancements in pharmacovigilance practices.

Qualifications:

• MD or equivalent medical degree.
• Minimum of 10 years of experience in drug safety and pharmacovigilance, with at least 5 years in a leadership role.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Proven track record of successful