Our client is a leading international player in regulatory and pharmacovigilance services for the pharmaceutical and medical device industry. They support global pharmaceutical companies across all activities related to product approval, development, and lifecycle management.
The organization operates in a consulting environment, involving multi-client management, performance tracking, and high-level technical delivery.
Role Overview
As a Manager in Local Pharmacovigilance, you are responsible for the execution of operational tasks, technical delivery, and project management within the field of local pharmacovigilance.
You manage local pharmacovigilance activities for multiple clients, are officially nominated with the relevant authorities, and assume local regulatory responsibility. This is a technical and operational role in a consulting environment, without hierarchical team management.
Key Responsibilities
1) Local Pharmacovigilance Management
* Set up and maintain the local pharmacovigilance system
* Manage and follow up on adverse event reports (ICSRs)
* Ensure compliance with national and European regulatory timelines
* Collaborate with global client teams
2) Surveillance & Compliance
* Perform regular scientific literature review (literature screening)
* Contribute to Periodic Safety Update Reports (PSUR)
* Support Risk Management Plan (RMP) activities
* Participate in audits and inspections
3) Coordination & Communication
* Act as the local point of contact for authorities
* Collaborate with Global Project Managers
* Provide regular reporting to clients
* Deliver internal training when required
4) Multi-client Management
* Manage a portfolio of approximately 20 to 30 clients
* Continuously prioritize urgent matters and regulatory obligations
5) Administrative Follow-up & Billing
* Accurately track working time (hourly time tracking)
* Ensure compliance with utilization and billing KPIs
* Maintain a high level of administrative rigor
6) On-call Duty
* Participate in an on-call rotation (1 week out of 4)
Profile
* University degree in Life Sciences (Pharmacy, Biology, Biomedical Sciences, Medicine, or equivalent)
* 2 to 4 years of experience in pharmacovigilance, with strong knowledge of applicable legislative and non-legislative guidelines
* Experience in a CRO or consulting environment is a plus
Key Skills
* Excellent organizational skills
* Strong attention to detail and accuracy
* Ability to manage multiple clients simultaneously
* Autonomous and proactive
* Service-oriented mindset
* Consulting mindset
Language Requirements
* Business fluent English
* Dutch and French as local languages (mandatory)
Conditions & Package
* Permanent contract – Full-time (40 hours/week)
* 20 legal vacation days + 12 additional RTT days
* 13th month salary and double holiday allowance
* Hybrid working model: 3 days remote work and 2 days on-site (Monday mandatory, second day defined by the team)
Compensation
* Monthly gross salary between €4,500 and €5,000 depending on experience
* Annual bonus of 7% based on collective, individual, and departmental performance
Additional Benefits
* Company car or mobility budget
* Meal vouchers and eco vouchers
* Hospitalization insurance, outpatient medical coverage, group insurance (4% of annual salary)
* Monthly net allowance