Pharmacovigilance Specialist: Drug Safety & Compliance Leader

Real; Haarlem; On-site; EUR 55,000 - 75,000; Full time

Job summary

Real, a leading global pharmaceutical company, is seeking an experienced Pharmacovigilance Specialist in the Haarlem area to support local and international drug safety activities. You will ensure compliance with pharmacovigilance regulations, manage adverse event reporting, and collaborate with QA, regulatory, and medical teams in a highly regulated setting.

This role offers broad exposure across PV, Regulatory Affairs, Medical Affairs, and Quality, with opportunities to drive continuous

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, Health Sciences, or a related discipline.
• Minimum 2 years of experience within Pharmacovigilance, Drug Safety, or Patient Safety in the pharmaceutical industry.
• Strong understanding of adverse event reporting requirements and PV regulations.
• Experience with case processing, safety reporting, and compliance activities.
• Knowledge of Pharmacovigilance quality systems and procedures.
• Experience supporting audits, inspections, or CAPA activities.
• Excellent English communication skills, both written and verbal.
• Strong stakeholder management and cross-functional collaboration skills.
• Ability to work independently and manage multiple priorities simultaneously.
• Strong analytical, organizational, and problem-solving abilities.

Responsibilities

• Execute and maintain local Pharmacovigilance processes in accordance with company procedures and regulatory requirements.
• Manage adverse event reporting activities, including intake, follow-up, assessment, and submission.
• Support implementation and maintenance of local PV agreements and compliance activities.
• Coordinate aggregate safety report submissions and Risk Management Plan activities.
• Support internal audits, vendor audits, regulatory inspections, and CAPA management.
• Develop, maintain, and improve local PV procedures, SOPs, and training materials.
• Conduct local literature screening and safety assessments where required.
• Monitor compliance with Risk Minimisation Measures and local PV legislation.
• Collaborate cross-functionally with Regulatory Affairs, Medical Affairs, Quality, and Commercial teams.
• Act as a local subject matter expert on Pharmacovigilance processes and regulations.
• Support business continuity planning and local safety governance initiatives.
• Review local initiatives, patient programs, and marketing activities for PV compliance.
• Contribute to Health Authority interactions and safety-related communications.
• Support training, onboarding, and development of PV capabilities within the organization.

Skills

English communication

Stakeholder management

Cross-functional collaboration

Independent work

Analytical skills

Organizational skills

Education

Bachelor's or Master's degree in Life Sciences / Pharmacy / Biomedical Sciences / Health Sciences

Job description

Real, a leading global pharmaceutical company, is seeking an experienced Pharmacovigilance Specialist in the Haarlem area to support local and international drug safety activities. You will ensure compliance with pharmacovigilance regulations, manage adverse event reporting, and collaborate with QA, regulatory, and medical teams in a highly regulated setting.

This role offers broad exposure across PV, Regulatory Affairs, Medical Affairs, and Quality, with opportunities to drive continuous