Pharmacovigilance (PV) Manager

What does a Regulatory Pharmacovigilance (PV) Manager do?

A Pharmacovigilance (PV) Manager is a key member of the pharmacovigilance (drugs safety) department in an organisation. Your expert pharmacovigilance knowledge and experience determine the safety profile of products and ensures they meet regulatory requirements. This involves adverse event monitoring, reviewing, analysing and preparation of reports with the help of your team. You also mentor your team and often advise colleagues in other departments and business units on aspects such as case handling, data extraction and analysis.

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What tasks and responsibilities can you expect as a Pharmacovigilance (PV) Manager?

Your tasks and responsibilities as a PV Manager will vary according to the organisation, and the size of the Pharmacovigilance Department (also known as a Drug Safety Unit – DSU). Overall, as an expert in the field you manage pharmacovigilance activities which can include safety reporting, adverse event monitoring, risk management and the application of regulatory requirements, for example.

Other typical tasks and responsibilities are:

• analysing and monitoring activities – reviewing completed cases to verify accuracy, consistency and compliance with all requirements;
• conducting any necessary follow-up on cases including corrective actions;
• keeping your knowledge of corporate policies and local regulations, guidelines and SOPs up to date as well as data entry conventions and search functions on the database;
• preparing and writing reports, input of information to aggregate reports and other regulatory documents as needed, to agreed deadlines;
• being the main point of contact as the expert in the Pharmacovigilance Department for the organisation concerned;
• being the expert for suppliers and stakeholders concerning pharmacovigilance-related issues;
• promoting and attending company safety activities, and liaising with key partners.

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What education and skills do you need as a Pharmacovigilance (PV) Manager?

You will need a minimum 4 years’ experience in pharmacovigilance or a related discipline for this role. A related discipline might be in scientific research, clinical care or data management, for example. Therefore, you will already meet the requirements for a relevant degree (preferably post graduate). A medical writing background is an advantage for report writing.
Other skills you will probably need include:

• comprehensive knowledge of pharmacovigilance concepts, including national and global regulations and guidelines;
• advanced computer skills, especially using relational database systems;
• a proven ability in excellent organisation and time management;
• the ability to lead a team to achieve set goals;
• good communication and writing skills in Dutch and English.

What salary can you expect as a Pharmacovigilance (PV) Manager?

The salary of a PV Manager will depend on your experience and the scope of the job in question. Your salary in the Netherlands is likely to be between €75.000,- and €100.000,- per annum, plus bonus in many cases.

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