Mar 15, 2023

Pharmacovigilance Project Lead

  • Melio Life Science
Full time Clinical Research Medical / Clinical Regulatory Affairs

Job Description

Title: Pharmacovigilance Project Lead

Location: Remote/Hybrid (UK and EU positions available)

Job Summary:

The Pharmacovigilance Project Lead will be responsible for leading pharmacovigilance projects, ensuring compliance with regulatory requirements, and maintaining the safety of products. The individual in this position will work closely with cross-functional teams to manage safety issues for both marketed products and products in development. The Pharmacovigilance Project Lead will also be responsible for managing timelines, resources, and budgets for the assigned projects.

Responsibilities:

·       Lead and manage pharmacovigilance projects, including but not limited to signal detection, risk assessment, and safety reporting.

·       Ensure compliance with regulatory requirements and guidelines for pharmacovigilance.

·       Collaborate with cross-functional teams to manage safety issues for both marketed products and products in development.

·       Collaborate with the PV manager on project timelines, resources, and budgets to ensure the timely completion of deliverables within allocated resources.

·       Develop and maintain project plans, including project timelines, resource allocation, and risk management plans.

·       Provide regular project updates to senior management.

·       Experience with relevant aggregate reports (i.e. DSURs, ICSRs, and PSURs/PBRERs)

Qualifications:

·       Degree in pharmacy, medicine, nursing, or other relevant life sciences (An advanced degree is an advantage).

·       Minimum of 3 years of experience in pharmacovigilance.

·       Strong knowledge of global pharmacovigilance regulations and guidelines.

·       Experience leading pharmacovigilance projects is an advantage.

·       Strong leadership, interpersonal, and communication skills.

·       Ability to work effectively in a cross-functional team environment.

If you're interested, please get in touch!

Salary description

Competitive

Job Reference

NCC-D-1701

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