Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist

Biomapas

Remote, Europe

Responsibilities:

• Act as the Project Manager or deputy Project Manager for the assigned projects
• Perform accurate forecasting and contribute to budget planning, ensuring efficient functioning of the QPPV Office
• Update SOPs and act as a subject matter expert for PV in assigned company processes
• Maintain KPI reports and perform core and standard PV activities for assigned contractual partners
• Manage Full or local Pharmacovigilance systems and projects (or part of them) and/or central pharmacovigilance activities (e.g. end-to-end case processing, Aggregate Safety Reports, Risk Management Plans and risk minimization activities) in both pre- and post-authorization setting (as applicable)
• Act as a customer contact point (where applicable), ensuring consistent communication and escalation management across assigned projects
• Act as the appointed EU QPPV or deputy EU QPPV in accordance with a separate QPPV Job Description (if applicable)
• Ensure high-quality performance of PV services in assigned region/country and timely communication with Health Authorities
• Ensure inspection/audit readiness and finding remediation

Requirements:

• Biologist, Pharmacist, Medical Doctor, or other life science degree
• 4-year experience in global Pharmacovigilance activities
• Fluent English
• Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety experience is an advantage)
• Strong organizational and time management skills
• Ability to work independently and in a team
• Strong organization, prioritization, and time management with reliable delivery of commitments
• Strong communication and relationship building skills across functional teams