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Archiviertes Projekt - Medical Safety Officer (m/f/d)

September 2019

nicht angegeben

Basel Land

auf Anfrage

12.09.2019

438162/1-en

Projektbeschreibung

Ihre Aufgaben:
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

Ihre Qualifikationen:
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

Ihre Vorteile:
A very renowned company

Projektdauer: 12 MM+


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