Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
We are currently looking for a Drug Safety Associate (PSMF & Business Support) to join our Drug Safety Team. Reporting directly to the Head Drug Safety Alliance Management, you will be responsible to manage Vifor Pharma’s EU- and other regional and local PSMFs, including quarterly updates of core text and annexes. Your tasks and responsibilities will include, but not be limited to, the following:
- Manage the regular updates of the EU- and other regional and local Pharmacovigilance System Master File (PSMF)s.
- Establish a global PSMF strategy for Vifor Pharma.
- Collaborate with Vifor Regulatory, Medical and Global Business organisations to develop and employ local solutions to meet country- and region-specific PSMF and QPPV requirements.
- Liaise with stakeholders from multiple departments and locations to obtain PSMF inputs.
- Manage PSMF submissions as required within and outside of EU.
- Liaison with local/regional QPPVs for maintenance of the contractual framework, access to PV information and oversight
- Support the Vifor Pharma Business Organisation to negotiate and conclude Safety Agreements for new business situations.
- Support the Vifor Legal Department to negotiate and conclude confidentiality and service agreements/work orders with e.g. external consultant companies and CROs.
- Support the IT Department to manage software licence and service agreements with vendors of the IT applications in use at Global Drug Safety.
- Liaise with Global Drug Safety functions and other Vifor Departments to find solutions to support local PV operations.
- Liaise with Affiliates and Partners and with Vifor functions within and outside of Global Drug Safety to negotiate terms of Safety Agreements, according to corresponding procedures and using the approved document templates.
- Other projects on assignment.
The ideal candidates is holding a university degree in pharmacovigilance / pharmacology / medicine / healthcare / other life sciences or business administration / law in addition to the following experience:
- Minimum of 2 years working experience in pharmacovigilance at a pharmaceutical company or CRO, preferably including experience in post marketing surveillance / drug safety operations and PSMF management
- Good knowledge of pharmacovigilance regulations (GVP, FDA), prefrably good knowledge of worldwide/regional/local pharmacovigilance regulations (Emerging Markets, MEA or CIS/RU experience preferred)
- Fluency in English, French or Spanish are a plus
- Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Experience in management of safety data exchange agreements, clinical trial agreements, quality agreements or similar specialist pharmaceutical or medical device industry agreements preferred
- Experience in management of external consultants preferred
You bring good interpersonal skills with a problem and conflict solving attitude. You have strong communication skills orally and in writing and good analytical skills. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You work effectively in cross-functional teams, with the ability to develop good working relationships with service providers and global partners.
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.