We are currently looking for a Therapeutic Area lead to join our Global Drug Safety and Risk Management Team. In this leadership role you will be reporting directly to the Global Head of Medical and Clinical Drug Safety, you will be responsible to ensure the scientific foundation of the Benefit-Risk profile of our products as well as the 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 and deliver 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, unblinding) 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 in addition to the following experience:
- Medical Degree, ideally clinical experience as Specialist in Internal Medicine, Cardiology or Nephrology or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety
- Experience with Benefit-Risk profile process implementation and monitoring
- Experience in leading a team of Drug Safety Physicians or Scientists or proven line management experience
- Experience in data analysis, signal management and Benefit-Risk evaluation for at least 5 years
- Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)
- Fluency in English
- Experience in Pharmaceutical Medicine development, 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 for both post-marketing medicines as well as medicines in clinical development (particularly dossier submission).
- Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues
- Experience with Health Authority inspections (EMA, FDA, other)
- Good computer literacy with experience with safety data bases (Aris G preferably) and IT affinity
- Capable of exercising oversight in professional communications and problem solving liaisons with internal and external customers at senior level
- 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
- Experience of or capable of lecturing at international drug safety conferences
You bring very good scientific, pharmaceutical and medical knowledge. You have excellent verbal and written communication skills as well as demonstrated leadership skills and are able to become quickly a valued and esteemed senior member of our interdisciplinary teams. You are able to build and maintain good relationships with a strong customer focus. You will professionally and successfully represent the company on the Benefit-Risk related matters in front of Health Authorities or other important external organisations or events. Your 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 are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. 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 and build a well-functioning team with high quality output in good team spirit.
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 companys 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