PV Scientist, Global Pharmacovigilance
2275 Research Boulevard, suite 500, MD 20850
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
This is a temporary role, anticipated to be for 6-12 months.
This position is located in Conshohocken, PA, Rockville, MD or remote. A remote work location is flexible if approved by the Company except that the position may not be performed remotely from Colorado.
- Perform routine and ad hoc safety surveillance activities such as signal detection, literature search and risk management to support the safety physician on one or more programs.
- Take lead in managing and reviewing periodic safety reports (e.g. DSUR, PSUR, PBRER)
- Provide support to PV operations in ICSR quality oversight and in working with QA to maintaining a state of high PV inspection readiness across all regions/countries.
- Contribute to activities in the monitoring of compliance with regulations and development of internal SOPs related to PV function.
- Represents PV department on clinical development teams, as assigned.
- Perform medical review of some individual case safety reports.
- Participate in regulatory inspections/audits and related activities; prepares responses to audit findings that concern the PV department.
- Supports the safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts.
- Keeping current on relevant regulations associated with the above activities.
- Support company REMS and RMP activities.
Experience & knowledge
- Minimum 2 years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety servient in PV Scientist or similar role.
- Degree in Biomedical or Health Care related specialty (MD, RN, MS, RPh, MPH)
- Strong knowledge of clinical development process
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
- Expert evaluation skills and analytical thinking
- Demonstrated ability to work effectively either independently or collaboratively in a team environment, both internally or with external colleagues.
- Knowledge of drug approval process in major countries
Education & qualifications
Degree in Biomedical or Health Care related specialty
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.