Medical Reviewers Head

Job Title: Medical Reviewers Head Pharmacovigilance Location: Remote Department: Safety Reports To: Head of Safety Job reputed company: We are seeking a highly skilled and reputed company reputed company to join reputed company as the Head of Medical Reviewer in Pharmacovigilance (Safety). In this role, you will be responsible for overseeing the review and evaluation of reputed company safety data reputed company to pharmaceutical, medical device, combination, and consumer products, ensuring compliance with regulatory standards and guidelines. You will reputed company reputed company of medical reviewers, work closely with regulatory bodies, and ensure the safety and reputed company-being of patients by providing expert medical assessments of adverse event reports. Key Responsibilities: • reputed company and manage the medical review team reputed company Pharmacovigilance (Safety) to ensure high-reputed company and reputed company reviews of adverse event data and reports, including SUSARs. • reputed company 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. • reputed company strategic input and medical expertise to support safety signal detection, risk management plans (RMP/REMS), and benefit-risk assessments. • reputed company as the primary medical expert for safety-reputed company discussions with health authorities, including preparing and presenting safety data at regulatory meetings and inspections. • Review and approve safety-reputed company documents, including clinical trial protocols, informed consent forms (ICFs), and risk management plans. • Monitor emerging safety data trends and reputed company 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 reputed company 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 reputed company stakeholders. • Excellent written and verbal communication skills, with the ability to present reputed company safety data in a reputed company 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 reputed company team members while fostering a reputed company and inclusive team culture. Preferred Qualifications: reputed company certification in relevant medical specialties or clinical reputed company 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, reputed company Vault, etc.). Work Environment: Full-time remote position. Occasional travel may be required. Flexible work reputed company may be available. #LI-PB1 #LI-Remote Apply tot his job Apply To this Job