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Medical Safety Officer (896529-J)

CTC Resourcing Solutions

 
Basel area
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Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Medical Safety Officer based in the Basel area.

Medical Safety Officer (896529-J)

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Medical Safety Officer based in the Basel area.

The ideal candidate should have at least 10 years of previous experience within the pharmaceutical industry, with at least 5 of them in Pharmacovigilance as well as a Medical Doctor degree.

 

Main Responsibilities:

  • Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection), benefit/risk assessment and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS);
  • Provide medical and safety expertise as the Global Medical Safety (GMS) representative on the Compound Development Team (CDT) and Clinical Teams;
  • Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
  • 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
  • Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR)
  • Health authority queries
  • Core Data Sheets (CDS)
  • 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 KOL’s.

 

Qualifications and Experience:

  • Physician (MD or equivalent) with 10 years related experience;:
  • At least 5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research in Pharma or academic setting, Medical Affairs);
  • Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience;
  • 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;
  • Ability to influence, negotiate and communicate with both internal and external stakeholders;
  • Experience With Health Authority Presentations Is Preferred;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

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