Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
To support our Global Drug Safety team, we are seeking a Global Head Medical and Clinical Drug Safety. You will lead the Medical and Clinical Drug Safety (MCDS) team, ensuring controlled fulfillment of all legal obligations and company duty-of-care requirements relative to drug safety / benefit-risk relating to MCDS activities. You will report to the Global Head of Drug Safety and Risk Management and be based at our Operational HQ in Zurich. You will manage Clinical Drug Safety, Medical Writing, Signal Management and the Therapeutic Area Drug Safety Lead groups. In addition you will oversee the outsourced CRO MCDS team. Your tasks and responsibilities will include, but not be limited to, the following:
- Manage and lead the Medical and Clinical Drug Safety Team including performance review, operational management, current and future resources
- Manage the medical review of worldwide reports on adverse events including confirming causality assessments and reportability
- Manage the medical review of worldwide scientific literature searches
- Manage the timely authoring of high quality aggregate safety reports (PADERs, PBRERs, PSURs and DSURs)
- Support the Regulatory Department with the evaluation of adverse event profiles of products to update regulatory documents and support in answering safety related health authority enquiries
- Support and conduct safety trainings for new staff, pharmacovigilance staff as well as refreshers
- Ensure safety tasks in clinical trials (including protocol review, SUSAR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations
- Signal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing Drug Safety Board presentations, change control of SmPC/CCDS, updating risk management plan and resulting actions plans
- Create and update the Risk Management Plans
- Active involvement in PASS or other safety studies
- Create and reinforce medical and clinical safety related SOPs, “Dear Investigator / Doctor letters”, if appropriate
- Coach and monitor the output of the Clinical Medical Regulatory Safety Teams
- Input into Drug Safety Data Management: timely outputs, development of further validated reports, strategical input in plans for data cleaning, data visualisation, data analytics
You bring an M.D. or PhD in a Scientific field in addition to the following experience:
- Minimum of 5 years’ experience in international drug safety, ideally operational as well as clinical drug safety
- Minimum of 3 years’ experience in a managerial role
- Experience in data analysis, signal detection and benefit/risk evaluation
- Excellent knowledge of international regulations (ICH, EMA GVP modules, EU CT Directive / Regulation, FDA CFR regulations)
- Fluency in English, German and French are an advantage
- Experience in pharmaceutical medicine, particularly clinical research, and/or experience in clinical pharmacology
- Knowledge and experience in 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) and data management
Very demonstrate good scientific, pharmaceutical and medical knowledge, showing concern for standards. You can think and influence conceptually, strategically and rationally. You are interpersonally aware and culturally sensitive, with the ability to work in a highly networked organisation with many partners. You work in an accurate and precise way with a proactive problem solving approach. You work in line with the Vifor Pharma values.
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.