Director, Clinical Safety Physician
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 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 andregulatory context.
Main Responsibilities and Accountabilities:
1) 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 clinical development teams on all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
2) Liaise with KOLs, set up and coordinate Advisory Boards and Drug Safety Monitoring Boards. Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
3) 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
4) Act as safety expert providing strategic input to key stake holders in relation to product safety. Understand the business strategy for assigned products and be knowledgeable on the product class.
5) Be the accountable 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. PSUR, RMPs, medical expert statements and answers to HA requests). Be content owner for safety relevant communications such as DHCP letters and company statements.
6) Perform due diligence investigation into safety profile of potential new product acquisitions and ensure that all necessary requirements are included in PV agreements, and also act as safety liaison to license partners
7) Participate actively in continuous improvement processes.
8) Develop and update of safety relevant chapters of the CCSI/DCSI including frequency tables for ADRs and justification documents for new safety information
9) Interface with other departments (e.g. clinical development, regulatory, health economics, medical affairs) with regard to safety issues
10) Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies
11) Provide expert advice (expert witness as required) to legal counsel regarding safety issues, as well as safety expertise to project teams
12) Contribute to safety risk management relevant training and mentoring
13) Analyze and prepare safety data for manuscript and/or publication submissions
14) Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.
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.
Ideal candidate will have clinical experience in pediatric hematology.