Global Safety Lead - Formulation Safety

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. 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. Strong product knowledge is needed for success in the role.

The role ensures that the medical and process standards delivered in CSLB are in alignment with the following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public:

• 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.

Responsibilities 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.
• Clinical Safety Development of the CSLB portfolio: Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports.  Oversees development of core safety information for new products.  Sets the strategy, reviews and approves key filing documents including Integrated Summary of Safety (ISS), Summary of Clinical safety (SCS), and risk management plans (RMPs). Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in CSLB’s studies.  Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions.
• Clinical Safety Representation: Chairs the Safety Management Team (SMT).  Represents GSPV in relevant cross functional teams.

Qualifications:

• Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.

• Two (2) years minimum experience as a physician in patient care.

• 3+ years pharmaceutical / biotechnology industry experience, with 1 of which include accountability for medical oversight/evaluation or clinical development.

• Industry experience in designated therapeutic area(s).

• Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.
 

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.