Drug Safety Lead Cardio Renal Product
Vor 2 Tagen
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
- 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
**About Us**:
**The Vifor Pharma Group** is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.
Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
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