Pharmacovigilance Analyst

Michael Page; Bogotá; Híbrido; COP 37.944.000 - 51.336.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Transportation allowance

Hybrid work arrangement

Contract: 1 year

Descripción de la vacante

Michael Page is seeking a Pharmacovigilance professional in Bogotá to ensure affiliate compliance with internal and external PhV requirements. The role covers AE management, reporting, and liaison with GPS across aligned countries.

The ideal candidate holds a health science degree, strong English medical language skills, and knowledge of regulatory guidelines. The position offers hybrid work and a 1-year contract.

Formación

• Bachelor's degree in a health profession (such as Pharmacy, Nursing) or life science field or equivalent demonstrated experience in patient safety.
• Knowledge of local, regional and global procedures as applicable.
• Knowledge of legislation with regards to relevant national regulatory guidelines, directives and regulations in Pharmacovigilance.
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Professional knowledge of English including medical terminology.
• Strong knowledge of quality systems.

Responsabilidades

• Execute pharmacovigilance activities as nationally required (AE management, expedited and periodic reporting).
• Serve as point of contact for reception and collection of AE reports and ensure timely reporting to GPS.
• Provide local training for employees and business partners to raise PhV awareness.
• Ensure accuracy and completeness of information from clinical trials, post-marketing studies, and spontaneous AE reports.
• Submit necessary case reports for expedited reporting to MoH/RA and reconcile with partners.
• Help interpret relevant regulations and ensure MoH/RA and GPS policy compliance.

Conocimientos

Communication

Interpersonal

Organizational

Negotiation

English (medical)

Educación

Bachelor's degree in health profession or life science

Descripción del empleo

About Our Client

A leading global pharmaceutical company focused on developing innovative medicines to treat serious and chronic health conditions. It is particularly known for its work in areas such as diabetes, obesity, oncology, neuroscience, and immunology, with a strong emphasis on research, clinical development, and improving patient outcomes.

Job Description

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 primary PhV role the PhV back-up shall take up key responsibilities described in this document.

• General Responsibilities and Regulatory Compliance:
• Execute pharmacovigilance activities as nationally required (such as: adverse event management, expedited and periodic reporting
• Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
• Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.
• Adverse event (AE) management responsibilities:
• Serve as point of contact for reception and collection of AE reports.
• Adverse event/device case entry into the safety database.
• Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, both for initial and follow-up reports.
• Responsible for the accuracy and completeness of information reported from clinical trial, post marketing study and spontaneous adverse events for marketed products and devices.
• Complete case follow-up as directed or required.
• Responsible for generating and submission of the necessary case reports that are required for expedited reporting to the MoH/RA.
• Reconciliate case reports with business partners, medical information, and product quality.

Archive case source documentation

• Standards and Inspection Readiness:
• Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments
• Help to interpret relevant regulations and guidelines.
• Responsible for ensuring compliance with MoH/RA(s) requirements and GPS policies, procedures, and processes.

The Successful Applicant

• Bachelor's degree in a health profession (such as: Pharmacy, Nursing) or life science field or equivalent demonstrated experience in patient safety.
• Knowledge and understanding of local, regional and global procedures as applicable.
• Knowledge of legislation with regards to relevant national regulatory guidelines, directives and regulations in Pharmacovigilance
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Professional knowledge of English including medical terminology.
• Strong knowledge of quality systems

What's on Offer

• Salary: COP $4,000,000 per month.
• Transportation allowance.
• Contract: 1 year.
• Work arrangement: Hybrid.

Contact: Estefany Cely

Quote job ref: JN-082026-7091245