Safety Physician at Biomapas

, , Hungary -

Full Time

Start Date

Immediate

Expiry Date

04 Jun, 26

Salary

0.0

Posted On

06 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Data Evaluation, Risk Management, Signal Detection, Pharmacovigilance, Data Analysis, Regulatory Submissions, Medical Input, Safety Reports, Benefit-Risk Profile, Medical Assessments, Problem-Solving, Analytical Skills, Attention To Detail, Ms Office

Industry

Research Services

Description

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 lifecycle 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 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

Responsibilities

The Safety Physician monitors and evaluates the safety profile of clinical trial products throughout their lifecycle by reviewing safety reports, analyzing data to identify risks, and contributing medical input for safety reports like DSURs and ASRs. This role also involves developing risk management strategies and participating in signal detection and evaluation processes.