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Senior Pharmacovigilance Manager 100%

AurigaVision AG
Basel

2W

Our customer is a multinational pharmaceutical company with a wide portfolio in specialty medicines and OTC products. For the offices in Basel, we are looking for a

Senior Pharmacovigilance Manager 100%

Our customer is a multinational pharmaceutical company with a wide portfolio in specialty medicines and OTC products. For the offices in Basel, we are looking for a

Senior Pharmacovigilance Manager 100%
Basel

In this role you will be responsible for the local pharmacovigilance system in close collaboration with the global pharmacovigilance organization of the company. We are looking for someone with profound experience of Swiss regulations and the motivation to renew the local organization and processes.
Your main tasks
• Overseeing and conducting the routine pharmacovigilance tasks in an affiliate
o Case processing (collection, global database entry, QC, follow-up and submission)
o Collaborating with Regulatory Affairs on submission of PSURs and RMPs and implementation of CCSI
o Developing pharmacovigilance activities and risk minimization activities for the company’s products, agreeing them with Swissmedic and ensuring their implementation
o Responsible for developing and maintaining local pharmacovigilance agreements
o Coordination of Health Hazard Assessments
o Reconciliation activities
o CAPA management
• Responsible for pharmacovigilance compliance with Swiss regulations and local SOPs, also for external contractual partners, including training and SOP maintenance
• Main contact for Swissmedic on all pharmacovigilance matters
• Representing drug safety and providing relevant inputs in local projects and activities
• Leading the Local Pharmacovigilance team, including budget responsibility
Your profile
• Master degree in life sciences, pharmacist, or health science professional degree
• At least 5 years’ experience in Swiss pharmacovigilance, mainly in pharmaceutical industry
• Profound knowledge and understanding of Swiss regulations with regard to pharmacovigilance practices
• Very good knowledge of ICH (GCP) and EU Good Pharmacovigilance Practice (GVP)
• Fluency in English and German is a must, language skills in French and/or Italian is a strong plus
• You are detail oriented showing a high level of responsibility and accuracy
• You are a team player with strong communication skills
Regina Kolb is looking forward to receiving your application documents (CV, diploma, reference letters; no motivational letter necessary):
• reference number 1956
• by mail to jobs@aurigavision.com or through our website www.aurigavision-career.ch
Full discretion is guaranteed and we will gladly answer any additional questions.