Senior Manager Pharmacovigilance (m/f/d)
CSPV Quality Assurance & Control: Maintaining a quality infrastructure within CSPV that complements the quality landscape within the biosimilars unit (FK-SBS) and the central Global Vigilance (GV) function. Contributing to workflows and process that provide quality through design. Acting as the custodian for all quality documents for which CSPV is the process owner (incl. updates, retirement etc.). Holder of the CSPV training matrix. Overseeing CSPV inspection readiness and acting as the coordinator during audits and inspections of CSPV including preparation, conduct and post-event activities such as CAPA management.
CSPV Vendor Oversight: Acting as the liaison and quality assurance partner for providers of services to CSPV (e.g. assuring the suitable qualification of contracted service providers, on-boarding and relevant subject matter training by CSPV). Holder of the documents outlining the nature and means of oversight over service providers to CSPV (incl. oversight methodology and agreed upon performance metrics). Monitoring the performance of service providers (e.g. late case processing, case quality). Identifying and classifying compliance risks for outsourced activities and for risks at the interfaces and handovers to Fresenius-Kabi.
CSPV Compliance Monitor: Monitoring and documenting workflow and process compliance within CSPV to designated recipients. Establishing and maintaining suitable systems in CSPV to monitor and communicate compliance, including the design and upkeep of suitable work-aids, checklists, dashboards, tracking documents and reports. Subject matter expert of compliance risks, codified requirements and expectations as outlined in inspection findings, health authority guidance, regulations and legislation concerning tasks and activities performed by CSPV.
CSPV Compliance Liaison: Facilitates communication of compliance data between CSPV and relevant Fresenius Kabi functions e.g. Global Vigilance (GV), the Corporate Safety Officer (CSO), other Vigilance Competence Centres (VCC) and central PV-Quality functions to ensure timely and informative communication on aspects of compliance concerning the FK-Pharmacovigilance System with respect to Biosimilars, but is not limited to
Providing in a timely manner relevant information via the CSPV Quality file for maintenance of the PUR (Global PV system Update Routine) by GV.
- Educated to university degree level in bioscience (or equivalent) with a solid understanding of the drug safety / PV area
- A minimum of 7 years industry experience in drug safety / PV, covering both a pre- and post-approval setting and with experience of quality assurance, service provider / vendor oversight, audits, regulatory inspections and follow-up actions with CAPA plans
- Sound understanding of the operational aspects of drug safety / PV from the receipt of ICSRs through processing and handling up to report compilation and submission, as well as other sources of safety information (literature reports, authority reports etc.)
- Proven ability to interpret regulatory requirements into practical working models with appropriate documentation
- Professional experience in collaborating with internal and external business partners
- Able to negotiate and achieve commitment with respect to compliance critical tasks and activities
- Ability to work independently in a small and agile team
- Strong team player with excellent networking skills
- Solution and results orientated, showing clear thinking and the ability to simplify potentially complex issues and develop pragmatic proposals
- Efficiency and organizational skills with the ability to prioritize assignments according business needs
- Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
- Excellent verbal and written communication skills (in English language)