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publications, unpublished sources, databases, websites, social media sites, market research,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
Effective use of appropriate IT systems and programs.
Ability to understand in detail clinical, biomedical and scientific reports about
pharmaceutical products at a level to allow appropriate capture, review and processing of
Ability to analyse and appraise safety data as part of the ongoing benefit-risk assessment of
the company’s products.
Ability to make informed decisions after finding the relevant facts.
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
Understanding of relevant legal and related issues
European and Global PV Regulations
Medicines Act and Statutory Instruments.
Data Protection legislation.
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.
Ability to prioritise, plan and organise work with the appropriate sense of urgency based on
regulatory requirements and business needs.
Team management and leadership skills (for team leaders and managers).
Strategic planning (especially for managers).
Understanding of the needs and priorities of regulatory bodies.
Use of effective questioning to accurately record safety data.
Ability to actively listen.
Courteous manner and consideration of others' views.
Informing management of important issues as they arise which require their attention.
Ensuring all company employees and contractors are appropriately trained to capture safety
Actively increasing awareness of Pharmacovigilance requirements to colleagues and third
parties in appropriate ways.
Compliance with regulatory requirements.
Compliance with standard operating procedures and company policies.
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