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 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.
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.
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.
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. PSUR, RMPs, medical expert statements and answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters and company statements.
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.
Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods and communication.
Review and contribute to safety relevant SOP and improvement of safety relevant SOPs.
Develop and update of safety relevant chapters of the CCSI/DCSC including frequency tables for ADRs and justification documents for new safety information.
Interface with other departments (e.g. clinical development, regulatory, health economics, pharmaco-epidemiology, medical affairs) with regard to safety aspects.
Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies.
Provide expert advice (expert witness as required) to legal counsel regarding safety issues, as well as safety expertise to project teams
Contribute to clinical safety risk management relevant training and mentoring.
Analyze and prepare safety data for manuscript and/or publication submissions.
Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.
Position Qualifications and Experience Requirements:
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.
Good scientific skills – able to understand scientific methods and think scientifically.
Ability to synthesize and analyze safety data from various sources.
Proficiency in problem-solving within a highly complex environment.
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.
Expertise in international regulations governing drug safety.
Knowledge of clinical research methodology, clinical epidemiology/biostatistics , pharmacovigilance tools and processes and relevant regulatory framework.
Experience in managing compliance or audits.
Specialization in a medical therapeutic area relevant for the CSL portfolio.
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