Acerca de nuestro cliente

The purpose of the role is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance (PhV) in aligned countries. In the absence of the primary PhV role, the PhV backup shall take up key responsibilities.

Descripción
- Execute pharmacovigilance activities as nationally required (such as adverse event management, expedited and periodic reporting).
- Responsible for appropriate communication between local product safety, Integral Patient Safety (GPS), and other relevant stakeholders (product complaints, medical affairs, and regulatory affairs).
- Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise awareness of PhV, as required.
- Strive for inspection and audit readiness, and participate in aligned affiliate inspections, audits, and assessments.
- Help interpret relevant regulations and guidelines and act as a contact person within the affiliate.
- Responsible for ensuring compliance with Ministry of Health/Regulatory Authority (MoH/RA)



requirements and GPS policies, procedures, and processes.
- Serve as the point of contact for the receipt and collection of AE reports.
- Enter adverse event/device cases into the safety database.
- Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, for both initial and follow-up reports.
- Be responsible for the accuracy and completeness of information reported from clinical trials, post‑marketing studies, and spontaneous adverse events for marketed products and devices.
- Complete case follow‑up as directed or required.
- Be responsible for generating and submitting the necessary case reports required for expedited reporting to the MoH/RA.
- Reconcile case reports with business partners, medical information, and product quality.
- Archive case source documentation.

Perfil buscado (h/m)

Bachelor's degree in a health profession (such as Pharmacy or Nursing) or a

📌 Pharmacovigilance Analyst (San Gil)
🏢 Michael Page Colombia
📍 San Gil