Director Clinical Safety & Pharmacovigilance (m/f/d)
For the assigned product or products, either directly or through effective delegation:
• Conceive and implement a clearly defined tailored safety strategy that serves to characterize the comparative safety profile of the assigned biosimilar product(s) against the matching originator i.e. reference product(s).
• Appropriately monitor the emerging safety profile of the biosimilar product(s); this includes the medical review and approval of ICSR, the conduct of periodic signal detection and evaluation exercises, and the compilation and submission of required aggregate periodic reports.
• Communicate emerging safety signals or other notable safety findings to key stakeholders within the company.
• Assess the risk-benefit balance of the assigned biosimilar products and initiate suitable risk management and risk mitigation / minimization activities.
• Ensure that subject safety and the expected product safety specifications are appropriately considered during the design, conduct, analysis and reporting of clinical investigations. This includes securing suitable safety monitoring during study conduct, as well as inclusion of suitable risk management and mitigation measures.
• Maintain a comprehensive level of knowledge about the biosimilar product(s), the matching originator i.e. reference product and the therapeutic area;
• Coach and mentor colleagues in the CSPV group and collaborating functions in the Fresenius-Kabi Swiss-BioSim Unit with respect to the safety of the assigned product(s) and the underlying methodology as required
• Act as a qualified and informed back-up for other members of the CSPV team, as needed.
• Represent clinical safety and pharmacovigilance on cross-functional teams for the assigned biosimilar product(s) in such a way that all negotiated and agreed upon deliverables and deadlines for these teams are met (may be delegated as appropriate).
• Contribute to and materially support the compilation of dossiers for marketing authorization applications (MAA) for all aspects pertaining to clinical safety for the assigned candidate biosimilars.
• Represent clinical safety and pharmacovigilance with respect to the assigned biosimilar product(s) externally, e.g. engagement with DSMBs / IDMCs. Contribute to and participate in health authority / regulatory agency meetings, interact with external advisers or opinion leaders, collaborate with colleagues from partnering companies (e.g. co-development or co-marketing).
• Provide product or disease area training with respect to the safety specifications of the assigned biosimilar product(s) and offer training on clinical safety and pharmacovigilance methodology to colleagues from other functions, as required.
• Communicate clearly and effectively during health authority / regulatory agency inspections concerning process and product-related aspects of the management of clinical safety and pharmacovigilance. Able to describe accountabilities and responsibilities accurately and succinctly when asked to by inspectors during pharmacovigilance or other regulatory authority inspections
Interfaces with other Departments/Functions:
• Biosimilars Project, Product and Program teams
• Biosimilars Regulatory Affairs Group, Biosimilars Clinical Development Team, and Leadership of the Fresenius-Kabi Leadership.
• Collaboration with Fresenius-Kabi central safety functions (CSO) including PV-QA and EU-QPPV, as required
• Health authorities / Regulatory agencies, Institutional Review Boards / Ethics Committees, members of IDMCs/DSMBs, Consultants and external subject matter experts and co-development partners, as appropriate.
• Service providers e.g. Contract Research Organization (CRO) staff and/or clinical investigators and site staff.
· Clinically versed MD with significant experience in pharmaceutical medicine (drug development and/or drug safety/pharmacovigilance)
· Excellent verbal and written communication skills (in English language)
· Industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety-based decision making)
· Excellent knowledge of product development process and experience of cross-functional teamwork.
· Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
· First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good understanding of either the oncology or rheumatology therapeutic area
· Professional experience in an international environment
· Several years of industry experience (minimum 10 years)
· Strong, mature project leadership and influencing skills
· Entrepreneurial thinking and striving to move project forward, within budget and timelines
· Strong team player and excellent networking skills
· Proven ability to chair meetings effectively
· Solution and results orientated
· Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets