Pharmacovigilance Physician

Pharmacovigilance Physician Location: Remote (United States) Department: Pharmacovigilance Reports To: Global Head of Pharmacovigilance and Drug Safety Employment Type: Contractor Join our Team Med Communications is seeking a Pharmacovigilance Physician (MD, DO, or equivalent) to provide medical expertise in the evaluation and interpretation of safety data for pharmaceutical products. This role is responsible for medical review of individual case safety reports, aggregate safety assessments, signal detection activities, benefit-risk evaluations, and support of regulatory safety reporting requirements. The Pharmacovigilance Physician serves as a key medical resource for client safety activities and collaborates with clients, regulatory authorities, and internal teams to support pharmacovigilance compliance and patient safety. What You'll Do As our Pharmacovigilance Physician Contractor you will: Safety Review and Medical Assessment Conduct medical review of individual case safety reports (ICSRs) and provide medical assessment statements. Review and interpret clinical trial and post-marketing safety data. Perform benefit-risk analyses and medical assessments for client products. Evaluate aggregate safety information for periodic safety reports and ad hoc requests. Support safety signal detection, evaluation, and verification activities. Pharmacovigilance Support Support pharmacovigilance systems for Med Communications and client programs in accordance with contractual requirements. Integrate regulatory and compliance requirements into medical assessment activities. Assist and support the Qualified Person for Pharmacovigilance (QPPV), as required. Client and Regulatory Collaboration Lead and participate in client safety meetings. Provide medical expertise during interactions with safety monitoring boards and regulatory authorities. Represent client interests in safety-related discussions when appropriate. Medical and Regulatory Documentation Assist in drafting, reviewing, and refining medical sections of: Periodic Adverse Drug Experience Reports (PADERs) Periodic Safety Update Reports (PSURs) Development Safety Update Reports (DSURs) Periodic Benefit-Risk Evaluation Reports (PBRERs) IND Annual Reports Investigator's Brochures (IBs) Integrated Summary of Safety (ISS) documents U.S. and international product labeling documents Regulatory authority safety information requests Assist with drafting, reviewing, and refining risk management plans and risk evaluation and mitigation strategies when required by client contracts. What We're Looking For Education Either: Licensed Medical Physician (MD, DO, or equivalent) in good standing in applicable state(s) of licensure. Board certification in a therapeutic area relevant to client programs is preferred. Or: Unlicensed Medical Physician (MD, DO, or equivalent) with no record of past or present Medical Board disciplinary action and at least five (5) years of combined pharmacovigilance experience, clinical healthcare provider experience, or equivalent experience. Preferred: Degree or training in Epidemiology. Experience Minimum of five (5) years of pharmacovigilance experience in the pharmaceutical industry or equivalent experience, including: Clinical trials investigator Health authority inspector Epidemiologist Other related healthcare or drug safety roles Knowledge, Skills, and Abilities Technical Knowledge Understanding of pharmacovigilance regulations and compliance requirements from: U.S. Food and Drug Administration (FDA) European Medicines Agency (EMA) Japan Pharmaceuticals and Medical Devices Agency (PMDA) United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) International Council for Harmonisation (ICH) Computer Skills Proficiency with Microsoft Office applications preferred. Experience with content management systems preferred. Why Join Med Communications? Join a collaborative team dedicated to supporting clients with high-quality pharmacovigilance services and maintaining a strong commitment to patient safety, regulatory compliance, and scientific excellence. Med Communications is an Equal Opportunity Employer and is committed to fostering a diverse and inclusive workplace.