Safety Physician

Join our global Pharmacovigilance team as a Safety Physician .

Safety Physician is responsible for monitoring and evaluating the safety profile of clinical trial products throughout their life cycle in phases. This role will play a critical role in ensuring patient safety by analyzing and interpreting safety data, contributing to the risk management process, and supporting regulatory submissions for post-marketing.

Position is in any EU country.

Responsibilities:

Safety Data Evaluation:

• Review and assess Clinical trial safety Reports, adverse events, SUSARs for potential safety signals
• Analyse and interpret clinical safety data to identify potential risks associated with drug products
• Provide medical input for the preparation of safety reports, including Development Safety Update Reports (DSURs), and Annual safety reports (ASRs)

Risk Management:

• Contribute to the development and implementation of risk management strategies for drug products
• Participate in the continuous monitoring of the benefit-risk profile of assigned products
• Provide medical insights for the creation of safety-related labelling changes

Signal Detection and Management:

• Participate in signal detection activities and contribute to signal evaluation and management processes
• Conduct medical assessments of signals and recommend appropriate actions

Qualifications:

• A minimum of a bachelor’s degree in medical, biomedical science
• At least 5+ years of experience in safety and pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry
• Oncology and immunology background is mandatory
• Experience in clinical trial safety and medical review of adverse events with knowledge of global PV regulations.(NI2.1)
• Proficiency in both verbal and written English and Local language is preferable
• Strong expertise in MS Office applications
• Attention to detail and strong analytical skills
• Problem-solving skills, particularly in identifying and mitigating health risks