We are currently looking for a Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:
Manage the review of worldwide reports on adverse events including confirming company causality assessments
Manage the timely authoring of high quality aggregate safety reports
Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documents
Support safety trainings for new staff, pharmacovigilance staff as well as refreshers
Implementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc.
Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations
Provide support in checking or preparing expert reports as appropriate and preparing safety regulatory files
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
Active involvement in PASS or other safety studies
Creation/authoring of Medical / Clinical Safety related SOPs
The ideal candidate holds an M.D. degree. Your profile consists of the following experience:
Medical Degree, ideally Specialist in Internal Medicine or Pharmaceutical Medicine
3-5 years’ experience in the pharmaceutical industry
Experience in data analysis, signal detection and benefit/risk evaluation
Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)
Experience in Pharmaceutical Medicine, particularly Clinical Research, Clinical Pharmacology, and Pharmacoepidemiology
Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues
Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
Good computer literacy with experience with safety data bases (ArisG preferably)
Capable of exercising oversight in communications and problem solving liaisons with internal and external customers
Capable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety development
Fluency in English
You bring very good scientific, pharmaceutical and medical knowledge. Your positive, optimistic attitude and behaviour is congruent with the company values. You show concern for standard and take a thorough approach, with high attention to detail. You can think and influence conceptually, strategically and rationally. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You are able to actively participate and contribute to an interdisciplinary team. You have excellent verbal and written communication skills. Affinity to IT would be an advantage. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.
A propos de nous
Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.
Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).