Medical Reviewers Head- Pharmacovigilance

The company is seeking a highly skilled and experienced professional to join their team as the Head of Medical Reviewer in Pharmacovigilance (Safety). In this role, the candidate will be responsible for overseeing the review and evaluation of all safety data related to pharmaceutical, medical device, combination, and consumer products, ensuring compliance with regulatory standards and guidelines. He/she will lead a team of medical reviewers, work closely with regulatory bodies, and ensure the safety and well-being of patients by providing expert medical assessments of adverse event reports.

Role involves:

• Leading and managing the medical review team within Pharmacovigilance (Safety).
• Overseeing the medical evaluation and risk-benefit analysis of pharmacovigilance data.
• Ensuring compliance with global regulatory requirements.
• Collaborating with other departments.
• Providing strategic input and medical expertise to support safety signal detection, risk management plans (RMP/REMS), and benefit-risk assessments.
• Acting as the primary medical expert for safety-related discussions with health authorities.
• Reviewing and approving safety-related documents.
• Monitoring emerging safety data trends and provide recommendations to senior management regarding potential product risks and mitigation strategies.
• Ensuring training and development of team members to maintain high standards of medical review expertise.
• Contributing to the continuous improvement of pharmacovigilance processes, systems, and tools.
• Training team members on medical review and regulation, as needed.

Requirements:

• Medical degree (MD); advanced degree (e.g., Master’s or PhD) in relevant scientific fields is a plus.
• Minimum of 5-10 years of experience in pharmacovigilance, with at least 3 years in a leadership role.
• Strong understanding of global pharmacovigilance regulations, including ICH, FDA, EMA, and other regional requirements.
• Expertise in medical evaluation and risk-benefit assessments of adverse event data and safety signals.
• Experience leading and managing cross-functional teams and collaborating with internal and external stakeholders.
• Excellent written and verbal communication skills, with the ability to present complex safety data in a clear and concise manner.
• Strong critical thinking, decision-making, and problem-solving abilities.
• Proven ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Ability to mentor and develop team members while fostering a collaborative and inclusive team culture.

Role offers:

• Full-time remote position.
• Flexible work options may be available.