We have partnered with a leading global bio-pharmaceutical company in its search for a Sr. Pharmacovigilance Medical Director for Immuno-Oncology in its Boston based office! This world renown organization has had a tremendous amount of success in various therapeutic areas and has a prolific Oncology pipeline that has to potential to propel this organization into the realm of the world's leading biopharmaceutical company. It's worth noting that amidst COVID-19 this company is conducting virtual interviews and moving forward with remote starts until the virus subsides with the expectations that candidates are open to being based in the Boston office when it is safe to do so. Looking to explore a fantastic new career opportunity without having to leave the comfort of your own home? Then don't hesitate to apply!
The Sr. Pharmacovigilance Medical Director for Immuno-Oncology will have the following responsibilities:
- Provides technical and scientific expertise to ensure a proactive and integrated approach for identifying, monitoring and managing IO and cell therapy toxicities and potential patient safety risks.
- Viewed as the subject matter expert in Medical Safety for IO and cell therapy, mentors other PV physicians.
- Supports IO and cell therapy diligence activities, communicating at a senior leadership level the impact of patient safety data in terms of "go/no go" decisions or modification of development plans and/or study designs and the associated impact on development and regulatory timelines.
- Contributes to development of signal detection strategy.
- In collaboration with Oncology Medical Safety TA Head, ensures adequate resourcing for IO and cell therapy development programs.
- Functions as the Global Safety Lead for one or more IO or cell therapy programs as portfolio expands.
- Curates a network of expert consultants to assist with development and delivery of innovative patient safety strategies and evaluation of emerging novel and serious safety signals.
- Supports cross functional (within and outside Global PV) team evaluations in preparation for Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety Board.
- Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues.
The ideal candidate will have the following skill-set:
- Medical Degree with 2 years of clinical experience
- Hands on Medical PV experience with Immuno-oncology products.
