Pharmacovigilance Specialist

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

Sector: Pharmaceutical Industry / Pharmacovigilance / Drug Safety / Regulatory Compliance

About the Role

A leading global pharmaceutical company is seeking an experienced Pharmacovigilance Specialist to support local and international drug safety activities. You will be responsible for ensuring compliance with pharmacovigilance regulations, managing adverse event reporting processes, supporting audits and inspections, and collaborating with internal and external stakeholders to maintain the highest patient safety standards.

This role offers broad exposure across Pharmacovigilance, Regulatory Affairs, Medical Affairs, Quality, and Commercial functions. It is ideal for someone who can work independently while driving compliance and continuous improvement initiatives within a highly regulated environment.

Key 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.

Who We Are Looking For

You are an experienced Pharmacovigilance professional with strong knowledge of drug safety regulations, compliance requirements, and adverse event management. You enjoy working in a dynamic international environment and are capable of independently managing complex PV activities while partnering effectively with a variety of stakeholders.

Must-Haves

• 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.

Preferred

• Experience as Local Safety Officer (LSO), Local PV Contact, or QPPV back-up.
• Experience with Risk Management Plans (RMPs) and risk minimisation activities.
• Knowledge of EU GVP guidelines and Pharmacovigilance legislation.
• Experience with Pharmacovigilance agreements and vendor oversight.
• Previous exposure to global or regional Pharmacovigilance operations.
• Experience supporting Health Authority inspections.
• Project management experience within Drug Safety or Pharmacovigilance.
• Experience within a multinational pharmaceutical or biotechnology organization.