[ref. q5961224] PV Specialist (Risk Management) 2-4Yrs

Job Description

Job Description

5 days from office (2pm shift)

Once training is complete, we can of course have some flexibility.

Summary

This position is part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support drug and biologic products.

• Serve as primary author for PV-RMPs, utilizing various regional/local/company templates and ensuring compliance to regional/local regulatory requirements.
• Facilitate cross-functional review and approval of PV-RMPs.
• Respond to queries/requests from regulatory authorities regarding PV-RMPs.
• Independently manage project timelines associated with preparation and submission of PV-RMPs.
• Represent GPS Risk Management on cross-functional teams.
• Collaborate with country organizations in developing and managing PV-RMPs and associated commitment activities.
• Support training of new GPS Risk Management team members.

• Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Prior experience with other regional/local regulations is desired.
• Prior experience with the implementation of additional risk minimization measures is desired.
• Excellent analytical and critical thinking skills.
• Excellent oral, written, and interpersonal skills, including ability and comfort in leading cross-functional group discussions and meetings.
• Scientific/clinical knowledge and excellent scientific writing skills.
• Ability to independently manage long- and short-term project timelines and deliverables.
• Experience in responding to queries/requests from regulatory authorities.

• Bachelor's degree in nursing/biologic/medical/clinical field advanced degree and prior clinical practice experience is desired.
• Minimum two years prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
• Minimum two to three years general experience authoring PV-RMPs is required. Prior experience authoring EU RMPs is required experience with generic PV-RMP submissions within the EU is desired. Prior experience authoring PV-RMPs in non-EU regions is desired.