Pharmacovigilance Analyst

Michael Page Colombia; Singapore; Hybrid; SGD 17,000 - 20,000; Full time

Benefits offered by this job

Transportation allowance

Hybrid work arrangement

1 year contract

Job summary

Michael Page Colombia busca un profesional para asegurar el cumplimiento de farmacovigilancia a nivel de filial y coordinar con GPS y reguladores. Se espera gestión de AE, reportes y capacitación interna para aliados de negocio.

Se valorará experiencia en regulaciones de MoH/RA, alta capacidad de comunicación y dominio de terminología médica. Puesto híbrido con oportunidad de desarrollo profesional en la región.

Qualifications

• Se necesita título en salud o ciencias afines y experiencia demostrable en seguridad de medicamentos.
• Conocimientos de normativas locales y guías de farmacovigilancia aplicables.
• Dominio del inglés técnico y terminología médica.

Responsibilities

• Ejecutar actividades de farmacovigilancia según requisitos nacionales.
• Servir como punto de contacto entre seguridad de producto, GPS y partes interesadas.
• Capacitar a empleados y socios para aumentar la conciencia de PhV.

Skills

Communication skills

English terminology

Quality systems

Education

Bachelor's degree in health profession

Job description

• Competitive salary
• contribute to a company committed to improving patients' lives

Acerca de nuestro cliente

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.

Descripción

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.

1. 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.

2. 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

3. 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.

Perfil buscado (h/m)

• 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

Qué Ofrecemos

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