Global Safety Lead - Formulation Safety — CSL Behring
CHF 94'500 - 143'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- 61 days ago
SalaryCHF 94'500 - 143'000
Role overview
Integrate safety risk management activities of the product into their medical, business, and regulatory context.
The role serves as the safety representative in the cross-functional development teams and post-marketing product teams.
It is responsible for setting safety strategy for these global projects.
- Integrate safety risk management activities of the product into their medical, business, and regulatory context.
- The role serves as the safety representative in the cross-functional development teams and post-marketing product teams.
- Complying with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
- Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure.
Main responsibilities
- Complying with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
- Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure.
- Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.
- Contributing to the protection of patients and public health. and Accountabilities
- Safety Surveillance and Risk Management: Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment.
- Oversees the safety signal detection and medical signal evaluation process.
- Oversees analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion.
- Quality Management: Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.
- Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
- Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function.
Application process
- Located within CSLB’s GSPV department, the Director, Global Safety Lead, Formulation Safety provide expertise on all aspects of –clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and post approval. (S)He will apply sound medical judgment for analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation.
Additional details
- Contributing to the protection of patients and public health. Responsibilities and Accountabilities
- Represents GSPV in relevant cross functional teams.
Notes and original content
- Contributing to the protection of patients and public health.
- Responsibilities and Accountabilities
- Qualificati
