Director Clinical Safety Physician (f/m) Therapeutic Area Immunology
To provide guidance and 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 state of the art pharmacovigilance post approval. Apply sound medical judgment for analysis and interpretation of complex clinical and postmarketing 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.
Requirements:
Main responsibilities and accountabilities:
• Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of medicinal products
• Guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data and liaise with KOLs, set up and coordinate Safety Advisory Boards, be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
• Lead multidisciplinary teams (e.g. Safety Management Teams) regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information
• Act as safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class.
• Be the accountable content owner for all safety relevant content or safety relevant safety documents during clinical development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g. PBRER, RMPs, medical expert statements and answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters and company statement. Develop and update safety relevant chapters of the CCSI/DCSI including frequency tables for ADRs and justification documents for new safety information.
• Perform investigation into safety profile of potential new product acquisitions (due diligence processes) and ensure that all necessary requirements are included in PV agreements, and also act as safety liaison to license partners
• Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies, also provide input into publications, input to legal counsel on all areas of safety risk management.
• Contribute to continuous quality and process improvement and training.
Qualifications and experience:
• Physician (MD or equivalent)
• Minimum of 2, preferred 5 years pharmacovigilance and / or clinical research / clinical safety experience in the pharmaceutical environment (industry, CRO)
• Medical practice of at least 2 years, preferred is a specialization in a relevant medical area including medical practice
• Sound clinical acumen and a wide range of therapeutic area knowledge
• Ability to synthesize and analyze safety data from various sources
• Proficiency in problem-solving within a highly complex environment
• Expertise in international regulations governing drug safety, knowledge of clinical research methodology, clinical epidemiology/biostatistics , pharmacovigilance tools and processes and relevant regulatory framework and experience in managing compliance or audits as well as specialization in a medical therapeutic area relevant for the CSL portfolio are of advantage
• Strong communicator with excellent English language skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing. Convincing argumentation and negotiating skills
• Good networking and team skills for successful cooperation with internal and external customers
