Global PV Physician
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Senior Drug Safety Physician for a permanent position based in Basel area.
The ideal candidate should have 10 - 15 years of previous experience in clinical and post-marketing safety and or clinical development in the pharmaceutical or biotechnology industry.
- Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle;
- Leads the cross-functional Safety Management Team (SMT) for assigned projects/products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management;
- Coordinates and ensures good quality presentation by the SMT at Client Drug Safety Committee;
- Provide drug safety expertise in all phases of drug development;
- Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information;
- Responsible for the preparation of aggregated periodic safety reports: DSUR, PSUR/PBRER, Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contribute to other key regulatory key safety documents;
- Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Pediatric Investigation Plan (PIP) as required;
- Represents Client in interactions with Health Authorities and Independent Data Safety Monitoring;
- Responsible for responses on safety inquiries from regulatory authorities or health care professionals.
Qualifications and Experience:
- Doctor of Medicine degree with at least 10-15-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry;
- Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information;
- Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance;
- Full understanding of the clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents;
- Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements;
- Previous experience with regulatory filing and contribution to key safety documents;
- Good experience and knowledge with safety signal identification methodology and risk minimization measures;
- Excellent medical writing, presentation and communication skills;
- Relevant working/residency permit or Swiss/EU-Citizenship required.