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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publications, unpublished sources, databases, websites, social media sites, market research,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’s 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

Understanding of relevant legal and related issues

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


 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.


 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.
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
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