Pharmacovigilance Compliance Specialist

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 put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more!

We, Akkodis Life Sciences, are looking for a Pharmacovigilance Compliance Specialist who can strengthen the team at our customer, European Medicines Agency, in Amsterdam.

Your role

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

Purpose of the role:

• Perform PV Compliance related tasks systematically and effectively while complying with PV related local regulations, procedural documents, and job aids.
• Interface directly with internal PV and non-PV subject matter experts, including the PV responsible staff in the affiliates, and other Astellas partners, including 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. The role is intended to function as a short-term project management resource rather than a routine operational role.

Key Responsibilities

• Perform root case analysis (RCA) pertaining to ICSRs submitted late to health authorities, CROs and business partners;
• Perform data entry of RCA conclusions into the global safety database;
• Perform QC of data;
• Manage excel based spreadsheet RCA tracking tool;
• Manage weekly/bi-weekly meetings with case processing vendor(s) to discuss and resolve RCA;
• Attend weekly Compliance team meetings and teleconferences with foreign colleagues, and project team meetings;
• Support PV including local affiliate staff, before, during and after, internal audits and external Health Authority; inspections, local affiliate audits, license partners audits and local PV inspections in own region, including onsite support if required;
• Participate in project improvement activities;
• Maintain timely and effective communications among cross-functional PV team members, vendors, and business partners.

What do we offer?

Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands.

• Temporary contract, depending on the budget the possibility to extend;
• Attractive salary;
• Work-life balance with 24 to 36 holidays;
• Company fitness, health insurance and 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 related field;
• Minimum 2 years of experience in Pharmacovigilance, Biotechnology, CRO , or 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 PV 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 do you want to come in touch?

Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV and motivation letter.