Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
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 candidates holds an M.D. degree in addition to the following experience:
- Medical Degree, ideally Specialist in Internal Medicine or Pharmaceutical Medicine / PhD or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety
- Or Pharma experience with university background with link to health care or patient health and scientific interest
- Experience in data analysis, signal detection and benefit/risk evaluation
- Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)
- Fluency in English
- 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 (Aris G 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
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.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.