Products:
- Small molecules, monoclonal antibodies, vaccines, medical devices, OTC, biosimilar, cosmetics, and food supplements.
Therapeutic areas:
- Oncology, Dermatology, Immunology/Inflammation, Infectious, CNS, Metabolic, Cardiovascular, Gastro-intestinal, Respiratory, Urology.
Post-marketing pharmacovigilance:
- Supported product launches: cetirizine, levetiracetam), certolizumab pegol (anti-TNFα), trifarotene (retinoid), isavuconazole, ceftobiprole.
- Phase 4 studies for several products. Close interactions with Medical Affairs, Marketing, and affiliates.
- Successfully managed several safety issues and safety related questions.
- Interacted with Health Authorities across the world for safety issues with potential business impact.
- Expert reports: for regulatory authorities, insurance companies, support of Legal department.
Clinical studies: (from Phase 1 to Phase 3)
- IDMC and safety review boards: sponsor representative, chair of internal safety data review meetings, firewall member in case review / discussion of unblinded data.
- Management of safety issues
- Optimisation of dose and dosing administration.
- Safety issues leading to project discontinuation.
- Measures leading to reduction of important safety concerns, including urgent safety measures.
Marketing authorisation applications
- Hands-on leading the safety aspects of multiple successful initial marketing authorisation submissions at health agencies and supported staff for initial submissions and line extensions.
- Meetings with FDA, EMA, and local Health Authorities, including public advisory meeting with FDA.
Risk management plan:
- Managed and contributed to a wide range of RMPs, whether initial or follow-up (immunology / inflammation, dermatology, psychiatrics, CNS, metabolic), including products requiring a patient registry, a controlled distribution, or a PASS.
Inspection /audits
- Global PV system inspections (post-marketing): preparation, interviewee, and back room.
- GCP inspections for clinical studies.
- Internal audits.
PV system
- Former Deputy EU QPPV; authored and reviewed SOPs.
- Aligned PV system to new regulations; set up post-marketing PV with local vendors and partners.
- Integrated medical PV activities after mergers.
- Steering Committee Member of outsourcing project: ensured vendor oversight
- Selected a new vendor for drug safety/PV.
Governance:
- Head Global Drug Safety (Basilea)
- Member of the PV Safety Leadership Team (different companies)
- Member of the Safety Board (different companies); Chair of Safety Board (Basilea)
- Member of Product Recall Committee (different companies)
- Qualified person for PV in Switzerland (Basilea)
- Member of Global Labelling Committee (different companies), Member of the QTc Committee, and the First-In-Man Committee (UCB)
Due diligence: several due diligences, mostly for in-licensing (all companies)