PV Implementation Specialist
Proclinical is currently recruiting for a PV Implementation Specialist with a pharmaceutical company located in Gaithersburg, MD.
- Lead validation activities must be skilled in authoring Validation documentation not limited to VP, UAT, PQ, TM, VSR
- Author and review SOPs, Work instructions including PV operations and PV systems procedures
- Develop Data entry guidelines in ARISg to support efficient case processing
- Author and review training documentation
- Support with troubleshooting of issues arising within Safety systems and support with quick resolution
Skills and Requirements:
- Experience in implementation of Pharmacovigilance Safety systems - ARISg preferred
- Very good understanding of FDA/EMA regulations and ICH standards
- Very good understanding of Pharmacovigilance business needs
- Very good understanding of Validation methodology pertaining to Clinical/PV needs
- Good understanding of GxP principles
If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.