Title: Senior PV Operations Manager
Salary: $125,000 - $170,000
Summary: Looking to make an impact?!?! This leading biopharmaceutical company that focuses on the development, discovery, and marketing of new medicines for people with cancer is seeking a devoted and motivated Senior PV Operations Manager to lead the Pharmacovigilance department in supporting new study teams and projects and supervision of the drug safety database. In addition of that, you will provide support to risk management for all clinical trials. Sounds like a great opportunity, right? Reach out and learn more about it!
Responsibility for this position includes:
- Responsible for ensuring that all pharmacovigilance actions are carried out in an efficient, consistent, and compliant way by performing key safety vendor oversight.
- Oversees and reviews the operations of an external vendor in case processing and submission, including the review and monitoring of compliance through various monitoring reports and other supervision activities.
- Manage vendor oversight, including KPI tracking, metrics, and quality control of SAE/ICSR instances in the Safety database.
- Ensure that the case reporting procedure for global clinical trials is quick and adheres to the reporting standards outlined in the safety management plans / PV agreements.
- Work together to ensure that case management, aggregate reporting, and signal detecting operations are all in sync.
- Assist in the creation of pertinent safety portions of clinical trial reports, yearly reports, accelerated safety reports, and other regulatory filing papers.
Qualifications for this position:
- Degree preferably in life science or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
- 5+ Years in direct pharmacovigilance work experience
- Ability to work independently & to manage work priorities
- Build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects
- ICSR submission experience is highly preferred
- Review, assess, interpret, and synthesize clinical and safety data with excellent clinical knowledge and analytic abilities.
- 401(k) Retirement Plan
- Medical, Dental, and Vision Insurance
- Non-accrual paid time off
If you are interested in the Medical Director role, then please don't wait to apply.