Tasks

- Perform medical review of SAE's
- Perform ongoing surveillance of safety data from different sources
- Ensure handling of safety issues and implementing risk mitigation activities
- Perform medical review and provide input to different documents e.g. trial protocols and amendments, clinical trial reports, trial plans, eCRFs/CRFs, TMFs, investigator’s brochures, Subject Informed Consent, Development Safety Update Reports (DSURs), Integrated Safety Summaries, scientific articles, etc.
- Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds
- Active involvement in for establishing and managing external data monitoring committees (DMCs)
- Participate and/or run safety committees for assigned products
- Conduct safety training of internal employees, CROs and investigators
- Contribute to multidisciplinary project groups and provide input to clinical development programs

Qualifications

- Medical Degree (MD) required
- Clinical research and/or fellowship training in oncology, onco-hematology, internal, cardiometabolic diseases, autoimmune diseases, pharmacology or other relevant specialty is a plus
- Solid Drug Safety / Pharmacovigilance experience gained in the Pharmaceutical industry
- Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance Practices
- Exposure to interactions with the EMA/Swissmedic/MHRA and FDA preferred
- Strong knowledge of individual adverse event case report processing, triage and medical review
- Working knowledge of safety databases and electronic data capture systems is preferred (such as ARIS G or Argus).
- MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries
- Experience with PV audit process with active participation in Regulatory Authority Inspections
- Excellent knowledge of drug development process