PV Implementation Specialist

Proclinical is currently recruiting for a PV Implementation Specialist with a pharmaceutical company located in Gaithersburg, MD.

Job Responsibilities:

• 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.

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