Local Contact for Pharmacovigilance, Colombia

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.

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