Local Contact for Pharmacovigilance, Colombia

hace 7 meses

Desde casa, Colombia IQVIA 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 post-authorization 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 follow-up of Individual Case Safety Report(s) (ICSRs) and/or other non-ICSRs safety information relevant to the medicinal product(s) in scope of the project.

**REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES**
- In-depth knowledge of applicable global, regional, and local regulatory requirements; and

International Conference on Harmonization (ICH) guidelines
- In-depth knowledge of the pharmacovigilance legal framework in Colombia.
- In-depth 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 problem-solving 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 co-workers, 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/post-marketing 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.

**#LI-Remote**

**#LI-MARIAARECHAGA

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