Beschreibung
Medical Safety Officer (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Strategically lead the Safety Management Teams (SMT) for assigned products
- Provide medical and safety expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams
- Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient risks by active participation in the design of the clinical protocols
- Be an active partner and core contributor of safety input to key regulatory or clinical documents
- Risk management plans, Safety development plan, Clinical Trial Protocols, Informed Consent Forms (ICF), Safety Sections of Investigator’s Brochure (IB) and IB addenda, Clinical Study Reports (CSR), Annual Safety Reports (ASR), Integrated Safety Summary (ISS) and Summary of Clinical Safety, (SCS) for NDA/BLA/MAA filings
- Contribute to structured benefit-risk assessment in development and post-approval in collaboration with the Benefit-Risk Team and Clinical teams
- Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations when necessary, to the GMS Leadership Team, CMO, and the Pharmaceuticals Medical Safety Council (MSC)
- Provide medical oversight for safety data evaluations by confirming the strategy for the safety review/analysis and endorsing the medical safety evaluation
- Actively participate and contribute to meetings with Health Authorities and external key opinion leaders
Main qualifications
- Physician (MD or equivalent) with related experience
- Pharmacovigilance experience or other relevant experience (e.g. Clinical research in Pharma or academic setting, Medical Affairs)
- Medical specialization preferred
- Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred
- Experience with structured benefit-risk frameworks (e.g. BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development is preferred
- Demonstrated knowledge of biostatistics and epidemiology are preferred
- Ability to influence, negotiate and communicate with both internal and external stakeholders
- Experience with Health Authority presentations is preferred
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Selma Hrustic
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