Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
We are currently looking for a Clinical Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Head of 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:
- Responsible for products in Clinical Development (Phase 1 to 3)
- Providing medical support to Clinical Drug Safety Unit
- Ensure and support the timely set-up, maintenance and close out of clinical interventional studies from a drug safety perspective
- Being involved in the selection process of Contract Research Organisation(s) (CRO) and continuous monitoring of the progress of clinical studies from a drug safety perspective
- Manage the review of worldwide reports on (serious) adverse events and suspected unexpected serious adverse reactions (SUSAR), including confirming company expectedness and causality assessments in the company’s Drug Safety/Pharmacovigilance Database
- Ensure safety tasks in clinical studies are handled appropriately and in compliance with regulations (incl. management and review of Study Protocol and Investigator’s Brochure, Case Report Form, SUSAR, Aggregate Safety Reports, Informed Consent Forms, Statistical Analysis Plan, Medical Monitoring and Review Plan, as well as involvement in expedited safety reporting, Data and Safety Monitoring Boards, Trial Master Filing; Investigator Meetings)
- As Clinical Drug Safety Subject Matter Expert, develop and maintain collaborations with cross-functional Clinical Study Teams and Benefit-Risk Teams
- Close interaction with Drug Safety counterparts from CROs as well as Co-developmental Partners
- Support the Global Regulatory Affairs department with evaluation of adverse event profile of product to update regulatory documents
- Providing support in Audits and Inspections
- Provide support in checking or preparing safety/medical expert reports as appropriate and preparing safety regulatory files
- Involved in signal detection and Benefit/Risk evaluation including initiating appropriate measures e.g. preparing Drug Safety Board presentations, change control of Company Core Safety Information/ Company Core Data Sheets updating risk management plans and resulting actions plans
- Being involved in creation and revision of (development) Risk Management Plans as well as Development Safety Update Reports
- Active involvement in other safety studies (e.g. Post-Authorisation Safety/Efficacy Studies)
- Creation of Medical/ Drug Safety related SOPs
- Support Drug Safety trainings for new company staff, Pharmacovigilance staff as well as refreshers
The ideal candidate holds an academic degree with following additional experiences:
- Preferable, holding a degree as M.D.
- And/Or degree from a Para-medical education (e.g. nurse, pharmacist)
- And/Or PhD in Life Science/Equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety
- Experience in data analysis, signal detection and benefit/risk evaluation
- Excellent knowledge of international regulations (ICH, GVP, EU Clinical Trial Regulations, FDA regulations)
- Fluency in English
- Experience in Pharmaceutical Medicine, particularly Clinical Research, and/or experience in Clinical Pharmacology
- Knowledge/Experience in Pharmacoepidemiology is a plus
- Minimum of 1-3 years of working experience in a CRO (Drug Safety, Trial/ Medical Monitoring) or in a Pharmaceutical Company in Clinical Trial related environment (Clinical Research/ Development, Drug Safety)
- Headquarter experience is a plus
- Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Clinical Drug Safety systems and procedures
- 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 and maintaining of Drug Safety issues with internal and external 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 attitude and entrepreneurial spirit is congruent with the company values. You take a thorough approach with high attention to detail and 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 have excellent verbal and written communication skills. 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.