Medical Reviewers Head- Pharmacovigilance

Job Title: Medical Reviewers Head- Pharmacovigilance

Location: Remote

Department: Safety

Reports To: Head of Safety

Job Summary:

We are seeking a highly skilled and experienced professional to join our team as the Head of Medical Reviewer in Pharmacovigilance (Safety). In this role, you 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. You 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.

Key Responsibilities:

• Lead and manage the medical review team within Pharmacovigilance (Safety) to ensure high-quality and timely reviews of adverse event data and reports, including SUSARs.


• Oversee the medical evaluation and risk-benefit analysis of pharmacovigilance data, including case narratives, serious adverse events (SAEs), and post-marketing surveillance.


• Ensure compliance with global regulatory requirements (FDA, EMA, ICH, etc.) and company policies in the evaluation and reporting of pharmacovigilance data.


• Collaborate with other departments, including Clinical Development, Regulatory Affairs, and Medical Affairs, to ensure seamless communication and efficient management of safety data.


• Provide strategic input and medical expertise to support safety signal detection, risk management plans (RMP/REMS), and benefit-risk assessments.


• Act as the primary medical expert for safety-related discussions with health authorities, including preparing and presenting safety data at regulatory meetings and inspections.


• Review and approve safety-related documents, including clinical trial protocols, informed consent forms (ICFs), and risk management plans.

• Monitor emerging safety data trends and provide recommendations to senior management regarding potential product risks and mitigation strategies.


• Ensure training and development of team members to maintain high standards of medical review expertise.


• Contribute to the continuous improvement of pharmacovigilance processes, systems, and tools.


• Train team members on medical review and regulation, as needed.

Qualifications:

• 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.

Preferred Qualifications:

Board certification in relevant medical specialties or clinical practice experience.

Experience in regulatory submissions, including new drug applications (NDAs), biologics license applications (BLAs), and post-market safety reporting.

Familiarity with pharmacovigilance databases and software (e.g., Argus, Veeva Vault, etc.).

Work Environment:

Full-time remote position.

Occasional travel may be required.

Flexible work options may be available.

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