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.
- Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of
- Ensures ICSRs are medically accurate, complete, coded appropriately (MedDRA), with appropriate causality assessment, seriousness and
- Ensures accuracy and timeliness of expedited reports and periodic reports from postmarketing surveillance and clinical
- Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature
- Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels)
- Actively participate in a multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues
- Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management
- Author medical-safety sections of aggregate safety reports (DSUR, PBRER)
- Participate in development of safety-related responses to queries from Regulatory Authorities
- Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.
- Maintain knowledge of Immunocore disease and therapeutic areas for marketed products and products in development
- Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, )
Experience & knowledge
- Experience in PGV, particularly with individual case review and evaluation.
- Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues.
- Knowledge of clinical development process
- Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
- Experience with different commercially available safety databases.
- Knowledge of drug approval process in major countries
Education & qualifications
M.D./D.O degree with at least two years of pharmacovigilance experience and at least two years of clinical experience or relevant experience to understand clinical drug development
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.