Pharmacovigilance Compliance Specialist | ASTELLAS | LEIDEN

Preferred start date: ASAP/01/10/2026 End date: 31/03/2027 Deadline to apply: 31-08-2026 Location: Hybrid (in accordance with our client’s responsible flexibility guidelines), Leiden

We are Akkodis. We prioritize the talents, skills, and ambitions of our Consultants. By continuously offering challenging projects, we help you develop and realize your ambitions. This is our view on good employment practices. Akkodis Life Sciences provides internal and external projects in QA, QC, PV, RA, R&D, Supply Chain, and related fields.

We have approximately 60 Consultants working with clients such as the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen, and more!

We are currently seeking a Pharmacovigilance Compliance Specialist to strengthen the team at our customer, the European Medicines Agency, in Amsterdam.

Your role Are you passionate about patient safety and regulatory excellence? As a Pharmacovigilance Compliance Specialist, you will play a key role in ensuring our global pharmacovigilance operations meet the highest standards of compliance. In this dynamic and collaborative role, you will work across departments and borders to support safety reporting, audits, and continuous improvement initiatives that directly impact public health.

Purpose of the role:

Perform pharmacovigilance compliance-related tasks systematically and effectively while adhering to local regulations, procedural documents, and job aids. You will interface directly with internal pharmacovigilance and non-pharmacovigilance subject matter experts, including responsible staff in affiliates and other Astellas partners, such as Quality Assurance, Regulatory Affairs, and external CRO representatives or business partners. The primary objective of this temporary position is to support the closure of open and pending RCA activities and other targeted quality and compliance improvement projects. This role is intended to function as a short-term project management resource rather than a routine operational role.

Key Responsibilities:

• Conduct root cause analysis (RCA) for late submitted ICSRs to health authorities, CROs, and business partners.
• Enter RCA conclusions into the global safety database.
• Perform quality control of data.
• Manage an Excel-based spreadsheet for RCA tracking.
• Organize weekly/bi-weekly meetings with case processing vendors to discuss and resolve RCA issues.
• Attend weekly compliance team meetings and teleconferences with foreign colleagues and project team meetings.
• Support pharmacovigilance activities including local affiliate staff during internal audits and external health authority inspections, local affiliate audits, license partner audits, and local pharmacovigilance inspections in your region, including onsite support if required.
• Participate in project improvement activities.
• Maintain timely and effective communications among cross-functional pharmacovigilance team members, vendors, and business partners.

What do we offer?

• Employment for 40 hours per week and the opportunity to work at innovative and progressive companies. You will be part of a fast-growing Life Sciences team represented in various industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands.
• Temporary contract, with the possibility of extension depending on budget.
• Attractive salary.
• Work-life balance with 24 to 36 holidays.
• Company fitness, health insurance, and a good pension scheme.
• Annual team events.
• Options to attend training, coaching, and a personal development scheme.
• Career opportunities matching your aspirations and development.

Your profile

Required Qualifications:

• Bachelor’s degree in Life Sciences or a related field.
• Minimum 2 years of experience in pharmacovigilance, biotechnology, CRO, or a related industry.
• Experience in quality assurance, case processing, or data assurance.

Preferred Qualifications:

• Strong written and verbal communication skills in English.
• Solid understanding of global pharmacovigilance regulations (e.g., ICH, FDA, EU GVP, JP).
• Proficiency in Excel, SharePoint, and safety databases.
• Familiarity with RCA tools (e.g., 5 Whys, fishbone diagrams, CAPAs).
• A proactive mindset with strong problem-solving and decision-making skills.
• Comfortable working in a global, multicultural team environment.

Are you interested in this challenge, or would you like to get in touch? Please contact your Talent Acquisition Specialist at Akkodis Life Science by sending your CV and motivation letter.