Title: Senior Manager PV Operations
We are partnering with a global pharmaceutical company that works on getting cardiology, oncology, women's health, and dermatology products on the market. As the Senior Manager PV Operations consultant, you will take charge in reviewing study documents, communicating with PV vendors, and working on quality compliance practices for the company's product portfolio. If you have an affinity for the mentioned therapeutic areas, enjoy looking over safety documents, and working with vendors, this may be the job for you!
The Senior Manager PV Operations will be responsible for:
- Participating actively in Study Management Teams (SMTs) as a representative of the PV Operations team
- Monitoring PV vendors to account for ICSRs, SOPs, and aggregate reports (SUSAR, PSUR, PADER, DSUR, IND)
- Overseeing creation of programs and Service Provider vendors to ensure rollout of MAPs and vendor partnership
The Senior Manager PV Operations should have the following qualifications:
- Bachelor's in health care field with at least 5 years of experience in drug safety
- Mastery of FDA regulations, ICH guidelines, and other regulatory documents
- CAPA deviation and CCDS work
- Can travel up to 20% for the job domestically and internationally
- Medical, dental, and vision insurance
If you are interested in the Senior Manager PV Operations role, apply today!