Senior Pharmacovigilance Scientist
Rockville, Maryland, United States
SENIOR PHARMACOVIGILANCE SCIENTIST, GLOBAL PHARMACOVIGILANCE
Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.
At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.
Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.
The Senior Pharmacovigilance Scientist supports the operational and medical components of pharmacovigilance activities including surveillance activities providing scientific/clinical pharmacovigilance expertise with focus on the identification, evaluation and management of safety risk for Immunocore products. The role will collaborate closely with the safety physician and cross-functional partners to evaluation and actively manage risks in accordance with global regulatory frameworks.
- 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.
- 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.
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical benefits, beginning your first day of employment
- Vision benefits
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
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.
Immunocore is an E-Verify employer.