Pharmacovigilance Physician

This is a fully remote position, open to applicants in Europe.

📋 Description

• Conduct medical evaluations of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing initiatives.

• Evaluate the seriousness, causality, and expectedness/labeledness of reported events.

• Examine MedDRA and WHO Drug coding for adverse events and concomitant medications.

• Draft medical assessments, company comments, medical summaries, and safety-related inquiries.

• Analyze cumulative data on similar adverse events, including the Analysis of Similar Events (AOSE).

• Offer medical support, guidance, mentoring, and training to the pharmacovigilance team.

• Review scientific literature to detect potential safety signals or valid ICSRs.

• Provide medical advice, data interpretation, and strategic counsel to internal departments, clients, and external partners.

• Assist in responding to regulatory authority requests, inspections, sponsor audits, and safety inquiries.

• Review and sanction periodic safety reports, including PBRERs, PSURs, and DSURs.

• Engage in signal detection, signal validation, and signal assessment activities.

• Contribute to benefit-risk assessments, Risk Management Plans, and Safety Management Plans.

• Participate in or present safety data at Safety Management Committees, Data Safety Monitoring Boards, and sponsor safety governance meetings.

• Provide occasional clinical medical monitoring support during peak workloads or team absences.

• Assist investigators with protocol eligibility, safety concerns, and data management inquiries.

• Review clinical trial data listings, laboratory reports, and subject profiles for medical accuracy and safety issues.

• Ensure pharmacovigilance and medical monitoring activities adhere to ICH-GVP, ICH-GCP, FDA, EMA, SOPs, and client requirements.

⛳️ Requirements

• Medical degree (e.g., MD, MBBS, MBChB, DO or equivalent) from a recognized medical school.

• Active or previously held medical license/registration.

• At least 2 years of experience as a physician in the pharmaceutical sector or a CRO, primarily focused on Pharmacovigilance and Drug Safety.

• Practical experience in conducting medical reviews of ICSRs.

• Familiarity with global drug safety and pharmacovigilance regulations, including ICH, FDA, and EMA.

• Strong scientific, clinical, and analytical expertise.

• Capacity to read, analyze, and interpret scientific and clinical data.

• Excellent verbal and written communication abilities.

• Proficient in navigating clinical and pharmacovigilance safety databases.

• Capability to exercise independent medical judgment and make timely, evidence-based decisions.

• Strong skills in cross-functional collaboration and communication.

• Solid understanding of MedDRA and WHO Drug coding dictionaries.

🏝️ Benefits

• Collaborative and adaptable working environment.

• Opportunities for professional advancement.

• Supportive culture centered on wellbeing, personal development, and work-life balance.

• Chance to impact patient safety on a global level.

• Meaningful work that benefits patients worldwide.