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Local Contact for Pharmacovigilance, Colombia

hace 4 meses

Colombia Novasyte A tiempo completo

PURPOSE
Act as local contact for pharmacovigilance for customers requiring the services for their product(s).

RESPONSIBILITIES

  • Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or postauthorization of safety studies of medicinal l products.
  • Remain up to date and aware of any changes in local regulatory requirements; verifies the
necessary mechanisms and regulatory measures adopted for safety reasons and the risk

management plans are carried out.

  • Establish and maintain a thorough understanding of each project's budget and scope of
work (SOW); set up and maintain project materials such as project files, forms, templates,

databases and workflow.

  • Work in a collaborative team environment with project team members both remotely and onsite; lead by example; assist management with allocating resources to projects. Will be
required to work independently within the QPPV role.

  • Proactively identify issues and propose solutions. Respond promptly and effectively to all
requests.

  • Provide regular reports to project manager on project metrics, SOW changes, customer
requests or concerns; participate in project review meetings with management, communicate and document project issues to project team members and department

management in a timely manner.

  • Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required. Support pharmacovigilance operations as required.
  • Get involved with collection, translation, recording and followup of Individual Case Safety Report(s) (ICSRs) and/or other nonICSRs safety information relevant to the medicinal product(s) in scope of the project.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

  • Indepth knowledge of applicable global, regional, and local regulatory requirements; and
International Conference on Harmonization (ICH) guidelines

  • Indepth knowledge of the pharmacovigilance legal framework in Colombia.
  • Indepth knowledge of relevant Standard Operating Procedures (SOPs).
  • Deal directly with the Competent Authority and undergo questioning by regulatory authority
inspectors during statutory inspections.

  • Possess excellent written and verbal communication skills
  • Excellent analytical and problemsolving approach when interpreting safety reports,
literature and undergoing inspections

  • Demonstrate a positive and motivational attitude
  • Demonstrate ability to work independently as well as within teams
  • Effective telephone etiquette
  • Strong organizational and project management skills
  • Demonstrate confidence, professionalism and credibility whilst interacting with customer and
third parties

  • Ability to establish and maintain effective working relationships with coworkers, managers,
customers and third parties

  • Maintain an overview of the safety profile of the product and factors that may affect the
benefit/risk balance of a product

  • Demonstrate an understanding of compliance and of quality management systems

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in medicine OR pharmacy and 2 years relevant clinical experience including experience managing clinical trial safety/postmarketing safety; or equivalent combination of education, training, and experience.
  • Resident in the country where LQPPV services if required by local legislation with fluent local language skills & excellent command of the English language.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

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