Competency Areas for Pharmacovigilance Professionals

Pharmacovigilance Competency Areas

Information management skills

  • Knowledge of relevant Pharmacovigilance information sources including: printed publications, unpublished sources, databases, websites, social media sites, market research, patients and healthcare professionals, investigator sponsored research and external bodies.
  • Effective understanding and use of the principles of information capture, storage, searching and retrieval.
  • Effective use of appropriate IT systems and programs.

Scientific knowledge

  • Ability to understand in detail clinical, biomedical and scientific reports about pharmaceutical products at a level to allow appropriate capture, review and processing of safety data.

Analytical skills

  • Ability to analyse and appraise safety data as part of the ongoing benefit-risk assessment of the company¬ís products.
  • Ability to make informed decisions after finding the relevant facts.

Communication skills

  • Ability to communicate information effectively and clearly in written form to allow sharing of safety data within the company and to regulatory bodies as required.
  • Understanding the wider context
  • Knowledge of the business and of the pharmaceutical industry.
  • Understanding of the external environment: the NHS, Government policy, regulatory requirements.

Understanding of relevant legal and related issues

  • European and Global PV Regulations
  • Medicines Act and Statutory Instruments.
  • Data Protection legislation.
  • Copyright.

Ethics

  • Understanding of, and compliance with, company policies, legal requirements, the European Good Vigilance Practice Modules, ABPI Pharmacovigilance Expert Network guidance and other industry guidelines that are relevant to pharmacovigilance.
  • Application of sound professional judgement to ethical issues.

Workload Management

  • Ability to prioritise, plan and organise work with the appropriate sense of urgency based on regulatory requirements and business needs.

Personal skills

  • Team management and leadership skills (for team leaders and managers).
  • Strategic planning (especially for managers).
  • Interpersonal skills.
  • Understanding of  the needs and priorities of regulatory bodies.
  • Use of effective questioning  to accurately record safety data.
  • Ability to actively listen.
  • Teamwork.
  • Courteous manner and consideration of others' views.

Proactivity

  • Informing management of important issues as they arise which require their attention.
  • Ensuring all company employees and contractors are appropriately trained to capture safety data.
  • Actively increasing awareness of Pharmacovigilance requirements to colleagues and third parties in appropriate ways.

Accountability

  • Compliance with regulatory requirements.
  • Compliance with standard operating procedures and company policies.

Continuous development

  • Developing and improving knowledge and skills.
  • Keeping abreast of developments in regulatory requirements.
  • Developing the role in line with regulatory requirements and the company's needs.Identifying and implementing improvements in ways of working - for self and for team/department.