Specialist Pharmacovigilance

TMC Sweden; Haarlem; On-site; EUR 55,000 - 85,000; Full time

Job summary

TMC Sweden in Haarlem is seeking an experienced Pharmacovigilance professional to lead and improve PV processes, ensure regulatory compliance, and support audits and safety reporting.

You will coordinate local PV activities, process adverse event reports, contribute to CAPA programs, maintain PV documents, and collaborate with health authorities and cross-functional teams to ensure high-quality safety data and continuous improvement across the PV system.

Responsibilities

• Executing and coordinating local Pharmacovigilance (PV) activities, ensuring compliance with legislation, regulations, and internal procedures;
• Processing, following up on, and reporting adverse event (Adverse Events) notifications in accordance with applicable PV guidelines;
• Supporting PV audits, inspections, and compliance activities, including drafting and following up on CAPAs;
• Preparing, maintaining, and improving PV procedures, SOPs, training materials, and other controlled documents;
• Managing Risk Management Plans (RMPs), safety measures, and literature screening;
• Monitoring the quality, archiving, and documentation of safety-related data;
• Advising internal stakeholders on PV regulations, processes, and compliance matters;
• Collaborating with health authorities, business units, external partners, and vendors;
• Representing Pharmacovigilance in cross-functional projects and governance structures;
• Supporting the PV Lead and acting as backup during absences;

Job description

About This Vacancy

Are you experienced in Pharmacovigilance and eager to contribute to the safety of medicines worldwide? In this role, you will be responsible for executing and improving PV processes, ensuring compliance, and supporting audits, inspections, and safety reporting.

• Executing and coordinating local Pharmacovigilance (PV) activities, ensuring compliance with legislation, regulations, and internal procedures;
• Processing, following up on, and reporting adverse event (Adverse Events) notifications in accordance with applicable PV guidelines;
• Supporting PV audits, inspections, and compliance activities, including drafting and following up on CAPAs;
• Preparing, maintaining, and improving PV procedures, SOPs, training materials, and other controlled documents;
• Managing Risk Management Plans (RMPs), safety measures, and literature screening;
• Monitoring the quality, archiving, and documentation of safety-related data;
• Advising internal stakeholders on PV regulations, processes, and compliance matters;
• Collaborating with health authorities, business units, external partners, and vendors;
• Representing Pharmacovigilance in cross-functional projects and governance structures;
• Supporting the PV Lead and acting as backup during absences;