We are currently looking for an Drug Safety Lead who will be based at our OM Pharma site in Geneva to support drug safety activities of the OM pharma portfolio.
Your responsibilities will include, but not be limited to :
Managing the review of worldwide reports on adverse events including confirming causality assessments
Managing the timely authoring of high quality aggregate safety reports
Creation and update of Risk Management Plan, implementation of additional PV activities or risk minimisation measures
Active involvement in PASS or other safety studies
Signal detection and benefit / risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plans
Supporting regulatory department with evaluation of adverse event profile of product to update regulatory documents
Ensuring safety tasks in clinical trials (incl. protocol review, SUSAR, ASR / DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations
Supporting safety trainings for new staff, pharmacovigilance staff as well as refreshers
Review of Medical / Clinical Safety related SOPs
The ideal candidate is bringing the following experience :
Medical Degree with 2-5 years of medical clinical practice or PhD / equivalent with experience in International Drug Safety (ideally operational as well as clinical drug safety)
2-4 years of experience in Pharmacovigilance
Experience in data analysis, signal detection and benefit / risk evaluation
Excellent knowledge of international regulations (ICH, GVP / EU, FDA regulations)
Very good scientific, pharmaceutical and medical knowledge. Experience in Pharmaceutical Medicine, particularly Clinical Research, and / or experience in Clinical Pharmacology is preferred.
Knowledge and experience in Pharmacoepidemiology is an advantage. Ability to interpret and apply global drug safety regulations
Fluency in English
Ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues is an advantage
Proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
Good computer literacy with experience with safety data bases (Aris G preferably)
You show concern for standards, you are thorough and attentive to details. You think and influence conceptually, strategically and rationally and have excellent analytical skills.
You have excellent verbal and written communication skills. You show initiative and ability to plan and prioritise workload and demonstrate proactive problem-
solving approach. You are effectively working in cross-functional environment with many partners. You are a team player with a positive attitude and act as a role model for others, in line with the Vifor Pharma Group Values.