Associate, Compliance, Utrecht, Utrecht

The Company
Our client is a leading international biotechnology company focused on developing innovative antibody medicines that improve the lives of patients with serious diseases. Their teams work across research, development, drug safety and quality to ensure that every product meets the highest standards of efficacy, safety and compliance.

Role Overview
As an  Pharmacovigilance Specialist you will play a key role in the Global Drug Safety & Pharmacovigilance (GDS&PV) Compliance team. You’ll support audits and inspections, SOP and document management, and PV process governance, helping to ensure that the PV system is always inspection?ready and compliant with global regulatory requirements.
This is an excellent opportunity for an experienced PV / QA professional who enjoys structure, documentation and stakeholder coordination in a fast?paced, highly regulated environment.

Key Responsibilities
-Coordinate and support preparation activities for internal audits, partner audits and health authority inspections.
-Maintain audit and inspection trackers, action lists and timelines, and follow up on actions with PV compliance and process owners.
-Support scheduling of audit/inspection meetings, interviews and readiness activities.
-Coordinate the collection, organisation and version control of requested documentation.
-Support inspection readiness activities, including evidence repositories, storyboards and trackers.
-Support maintenance of selected SOPs, work instructions and templates owned by the GDS&PV Compliance team.
-Coordinate document updates, reviews and approvals in the document management system.
-Track review cycles, comments and approvals, and follow up with relevant stakeholders.
-Ensure formatting, consistency and completeness of documents according to company standards.
-Act as deputy to PV process owners, supporting PV experts with process documentation, periodic reviews and tracking of agreed actions.
-Serve as an operational point of contact for process?related administrative questions.

Requirements
-Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Health Sciences, Quality or relate
-6+ years of industry experience in pharmacovigilance, drug safety, QA/compliance or similar roles in pharma/biotech.
-Excellent knowledge and understanding of regulatory guidelines and policies related to drug safety and pharmacovigilance (e.g. GVP, EMA/FDA requirements).Proven experience working in cross?functional teams in a fast?paced environment with tight timelines. 
-Strong background in SOP / document management, audits/inspections, QMS/DMS tools and process documentation.
-Ability to work proactively, independently and in a structured way, with strong attention to detail.
-Excellent communication skills (oral & written) and ability to collaborate with diverse stakeholders (scientists, trial managers, medical affairs, commercial, clinical development, QA). 
-Fluency in English; Dutch is a strong plus.
    
Apply Now
Ready to contribute to the safety and compliance of innovative antibody medicines?
Send your CV (and short motivation) to Valeria Chetrari at SIRE and let’s connect to discuss this opportunity in more detail.

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