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JOB DESCRIPTION

Pharmacovigilance Manager

Role overview

The Pharmacovigilance Manager is a health professional who works in the pharmaceutical industry or health institutions. This profession can be found in both human and animal medicine. It is open to medically trained professionals, in this case pharmacists, doctors and veterinary surgeons. This post is reserved for experienced people: to qualify, you need to have been in charge of pharmacovigilance for several years.

The role of the Pharmacovigilance Manager is to ensure the safety of patients who use medicines or pharmaceutical laboratory products. To do this, they supervise the monitoring of the effects of a drug before and after it is marketed. It assesses the risks and draws up recommendations in accordance with the procedures in force. The aim of these instructions is to reduce risks and promote the appropriate use of the medicine.

The Pharmacovigilance Manager works as part of a team. In a private company, they may report to the Medical Director, the Research and Development department or the Quality department. The job may be at national, continental or international level, in a subsidiary or a parent company.

This profession covers various areas such as management, communication and technical knowledge. Higher medical studies are compulsory. As a technician and relationship manager, the Pharmacovigilance Manager must be able to respond to health professionals, health authorities and patients. As a manager, they must be able to handle any situation relating to the use of pharmaceutical products.

 

Alternative Job Titles

  • Director of Pharmacovigilance
  • Senior Director Pharmacovigilance
  • Head of Drug Safety and Pharmacovigilance
  • Head of Safety Science

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Missions principales

Main Responsibilities

The Pharmacovigilance Manager is responsible for setting up the pharmacovigilance organisation. He/she maintains control over the quality profile of medicines and pharmaceutical products, in order to assess the benefit/disadvantage ratio of products.

As the senior manager, he or she is responsible for producing risk management plans. He or she oversees their implementation, the collection of clinical data through to archiving, and the development and transmission of reports. As a leader, he or she directs the team, ensures that staff follow the plans produced and represents them on the management committee.

The Pharmacovigilance Manager ensures that information is communicated internally and externally. He/she maintains relations with healthcare professionals and responds to internal auditors or health inspectors. He or she acts as an expert in institutions and certifies documentation where necessary.

When required by the company, the Pharmacovigilance Manager selects external partners and subcontractors. His or her role also involves studying and validating the clauses of the relevant contracts.

Competencies & Skills

 

  • Knowledge of national and international pharmacovigilance procedures: knowledge of regulations is fundamental to the job. The manager ensures that the company adopts regulatory procedures. He or she is responsible for keeping a regulatory watch. If necessary, when it comes to public health, they alert the relevant authorities.
  • Data analysis: the Pharmacovigilance Manager must be familiar with statistical tools. As a technician, he or she must be familiar with the handling and use of databases. The evaluation of information should enable them to anticipate health risks. This enables them to make recommendations. They must also ensure that the data is secure.
  • Communication skills: Pharmacovigilance Managers must be able to express themselves, circulate information and collect it. They need to know how to talk to healthcare professionals, patients, administrative staff, marketing managers and partners. Their work will probably bring them into contact with crisis situations and disputes. You need to be able to keep your cool and adapt to any interlocutor.
  • Familiarity with digital tools: this manager needs to know how to use applications and connected objects related to patient records. This enables them to monitor patient health. In addition, this job is dependent on scientific and technological advances in medicine, information transmission and so on. They must therefore be familiar with digital tools.
  • Demonstrate leadership:: as a team leader, the Pharmacovigilance Manager must be able to organise, motivate and unite his or her team for greater efficiency.
Main missions

Education & Training

  • Master in Clinical Research and Pharmacovigilance
  • Master in Pharmacoepidemiology
  • State diploma of doctor of medicine, pharmacy or veterinary medicine
  • Pharmacovigilance training for healthcare professionals

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