Director of Patient Safety and Pharmacovigilance
Vor 3 Tagen
Job Title: Associate Director Patient Safety Physician (gn)
Company: Agenéo Life Science Experts (Interim Solutions) GmbH
Job Summary:
We are seeking an experienced Associate Director Patient Safety Physician (gn) to join our team in the therapeutic area Cardio-Metabolism-Renal (CMR). As a key member of our global Patient Safety and Pharmacovigilance (PSPV) team, you will be responsible for orchestrating global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development.
Key Responsibilities:
- Collaborate with the clinical development department to devise patient-centric benefit-risk evaluations for developmental compounds.
- Work with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
- Analyze clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
- Provide medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
- Keep senior management apprised of the safety profile of designated drugs and suggest PV/RM actions.
Requirements:
- Medical degree with clinical and/or clinical research experience.
- Excellent English language skills, both written and verbal.
Benefits:
Global and intercultural work environment.
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