🕒 4 days ago
Coordinate QPPV office activities, oversee global pharmacovigilance agreement processes, and maintain authority-ready documentation, templates, and procedures that support regulatory compliance and patient safety.
Senior Pharmacovigilance Specialist
📅 Aug 28
PharmacovigilanceGlobal And Local PV SystemsPV Regulatory ComplianceProject Management
📜 Description
- Manage assigned pharmacovigilance systems, projects, and central PV activities, including case processing, safety reports, and risk management plans.
- Act as project manager or deputy project manager and customer contact for assigned projects, coordinating communication and escalations.
- Update SOPs, serve as a PV subject matter expert, and maintain KPI reports.
- Ensure quality, regulatory compliance, timely Health Authority communication, and inspection readiness, including remediation of findings.
- Perform core PV activities for contractual partners and, where applicable, serve as EU QPPV or deputy EU QPPV.
🛠️ 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
✨ Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home based
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
Full job description
Join our global Pharmacovigilance team as a Sr. Pharmacovigilance Specialist.
Senior Pharmacovigilance Specialist is responsible for supporting global and local PV systems and ensuring compliance with all PV activities with international or local regulations. May overtake additional regional or local PV responsible person roles for simple PV systems.
The position is remote, home-based in any EU country.
All CVs must be submitted in the English language for consideration.
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
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home based
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events
Similar jobs
Search more Clinical Operations Specialist jobs
🕒 4 days ago
The Regional Project Lead is a senior clinical trial manager responsible for overseeing project teams, ensuring compliance with regulations, and meeting study milestones across designated countries.
🕒 4 days ago
The Regional Project Lead is a senior clinical trial manager responsible for overseeing project teams, ensuring compliance, and meeting study milestones across designated regions.
🕒 5 days ago
The Regional Project Lead is a senior clinical trial manager responsible for overseeing project teams across regions, ensuring compliance and meeting study milestones.
🕒 5 days ago
The Regional Project Lead is responsible for overseeing and coordinating clinical trial activities across regions, ensuring compliance with regulations and meeting study milestones.