Manager, Pharmacovigilance & Training

PVG & Training Manager - Contract - Wilmington, DE

Shape safety and quality in pharma by leading as our Pharmacovigilance & Training Manager.

Proclinical is seeking a Manager, Pharmacovigilance & Training to support the development and maintenance of quality standards within the Pharmacovigilance department.

Primary Responsibilities:

The successful candidate will coordinate training for Pharmacovigilance staff, ensure training documentation is inspection-ready, and contribute to audit and inspection readiness activities. This position involves collaboration with internal teams, external service providers, and business partners to maintain compliance and uphold quality standards.

Skills & Requirements:

• Proficiency in written and verbal English for effective workplace communication.
• Strong verbal and written communication skills.
• Excellent organizational, time management, and problem-solving abilities.
• Ability to work effectively within a team environment.
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
• Knowledge of global Pharmacovigilance regulations, including CFR-GVP, ICH Guidelines, and GCP.
• Experience preparing and delivering training to diverse audiences.
• Familiarity with learning management systems; proficiency with Veeva eLMS preferred.
• Experience developing procedural documents and working with document management systems; proficiency with Veeva eDMS preferred.
• Bachelor's degree in a science or healthcare-related discipline or equivalent experience.

The PVG & Training Manager's responsibilities will be:

• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to maintain inspection readiness.
• Coordinate the development, review, and maintenance of Pharmacovigilance quality standards documents.
• Manage documents through their approval lifecycle within document management systems.
• Train Pharmacovigilance staff and external service providers as needed.
• Assist in identifying cross-functional SOPs requiring training and provide support for GPRM training.
• Maintain accurate and up-to-date Pharmacovigilance training records.
• Develop and maintain Pharmacovigilance training programs and initiatives.
• Provide technical expertise on quality standards and training processes.
• Identify quality issues, propose solutions, and escalate concerns when necessary.
• Support audit processes and inspections related to Pharmacovigilance.
• Review and provide feedback on Pharmacovigilance documents and templates.
• Assist with updates to the Pharmacovigilance System Master File as applicable.
• Collaborate with internal teams, business partners, and external service providers.
• Provide support to Pharmacovigilance leadership as required.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at [email protected].

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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