PV Implementation Specialist job in Gaithersburg, USA

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First Name*

Last Name*

Email*

Phone Number*

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Job type: Permanent

Discipline: Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

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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Salary

Highly Competitive

Location:

Basel, Switzerland

Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to search for a new Safety Director!