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International PV Business Process Leader
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. We are currently looking for a International PV Business Process Leader for a 12 months contract to be based in Basel, Switzerland.
- Act as Business Process Owner for Pharmacovigilance Affiliates in global Pharmacovigilance processes including (but not limited to) finding and engaging affiliates in global PV process design, development and maintenance and Pharmacovigilance process-related affiliate communication and trainings;
- Collaborate with CCLs, Affiliates and global functions like Safety Risk Management, Quality, Medical Affairs, Regulatory Affairs, or Clinical Operations to ensure high-quality and compliant affiliate execution of the global Pharmacovigilance processes;
- Work closely with the respective Global Process Owners and other Business Process Owners in other teams to ensure end-to-end process oversight of global Pharmacovigilance processes impacting Pharmacovigilance Affiliates, contribute to gathering and assessment of affiliate feedback for future process improvements;
- Design, influence and review Pharmacovigilance metrics and other data to support global and regional oversight form data capture perspective in the adequate platforms for local and regional reports;
- Detect and escalate issues impacting global Pharmacovigilance processes, lead and impact Pharmacovigilance improvement efforts, Pharmacovigilance initiatives and projects across the organization, support implementation of improvements and change management initiatives.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- PhD or MSc in Life Sciences or relevant life science or nature science discipline, or equivalent professional experience;
- 8+ or more years of experience in PV as well as clinical research, development, drug safety, quality science or related experience;
- 3+ years of experience working with Affiliate PV roles or a global role focusing on Affiliate support;
- Experience in process design and process-level oversight;
- In-depth knowledge of PV, GVP, ICH-GCP and other relevant standards and guidelines is essential;
- Understanding of medical and safety aspects of FDA, EMEA, NICE and other relevant regulations.