Pharmacovigilance Specialist

hace 3 semanas

Bogota, Colombia MSD A tiempo completo

**Job Description**:
The **Specialist **Pharmacovigilance** is responsible for pharmacovigilance activities (as delegated/assigned by their manager) which may include but is not limited to pharmacovigilance Intake activities (including reconciliation and followup), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local Pharmacovigilance agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local Standard Operational Procedures, conducting local training, and archiving and is able to perform these tasks with mínimal supervision.

The Specialist may serve as the Back-up local Qualified Person for Pharmacovigilance matters. In the absence of the Pharmacovigilance Lead, they may manage day-to-day Pharmacovigilance activities and serve as their back-up.

**Responsibilities**:

- Responsible for execution of local Pharmacovigilance (PV) processes and activities in collaboration with internal functional areas and external parties as assigned.
- Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy
- May coordinate translation of PV documents and ensure a Quality Control check is performed by a second person for any in-house translations (as applicable).
- Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors
- Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.

**Position Qualifications**:

- Health, life science, or medical science degree or equivalent by education/experience
- Minimum 2 years of Experience in the pharmaceutical industry in Pharmacovigilance roles.
- General knowledge of adverse experiences or events (AE) reporting requirements and relevant PV regulations is preferred, but is not required
- Must be fluent in English/C1 (written and spoken)
- Preferable knowledge of Power BI tool.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are **

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for **

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.**

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R222965

  • Safety Data Specialist

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Safety Data Specialist (Contrato Termino Fijo)**: - **Si bien el contrato es a Termino Fijo, tiene posibilidad de renovación según rendimiento** **Como Safety Data Specialist, en Global Pharmacovigilance Case Management, eres responsable de procesar la información de eventos adversos, en el sistema de seguridad global para...

  • Safety Data Specialist

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Como Safety Data Specialist, en Global Pharmacovigilance Case Management, eres responsable de procesar la información de eventos adversos, en el sistema de seguridad global para productos en investigación y/o comercializados, bajo la dirección y supervisión de un Gerente de Global Pharmacovigilance Case Management. El Safety Data...

  • Senior Safety Data Specialist

    hace 2 meses

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Senior Safety Data Specialist (Contrato Termino Fijo)** - Si bien el contrato es a Termino Fijo, tiene posibilidad de renovación según rendimiento Como **Senior** **Safety Data Specialist, **en Global Pharmacovigilance Case Management, eres responsable de procesar la información de eventos adversos de alta complejidad, en el...

  • Senior Safety Data Specialist

    hace 2 semanas

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Senior Safety Data Specialist (Contrato Termino Fijo)** - Si bien el contrato es a Termino Fijo, tiene posibilidad de renovación según rendimiento Como **Senior** **Safety Data Specialist, **en Global Pharmacovigilance Case Management, eres responsable de procesar la información de eventos adversos de alta complejidad, en el...

  • Sr. Specialist, Ra/pv Quality Business Partner

    hace 2 semanas

    Bogota, Colombia Organon A tiempo completo

    **Job Description**: The Sr. Specialist, RA/PV Quality Business Partner (QBP), performs tasks that help improve and sustain global and local quality and compliance of regulatory affairs and pharmacovigilance activities for all products within the Organon portfolio of drugs, medical devices, and combination products that are commercialized or in development...

  • Specialist, Drug Safety

    hace 3 semanas

    Bogota, Colombia MSD A tiempo completo

    The Specialist is responsible for Pharmacovigilance (PV) activities (as delegated/assigned by their manager) which may include but is not limited to PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due...

  • Health Care Compliance Specialist

    hace 3 semanas

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...

  • Medical Operation Specialist

    hace 4 días

    Bogota, Colombia ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...

  • Senior Specialist, Quality Assurance Auditor

    hace 2 semanas

    Bogota, Colombia Organon A tiempo completo

    **Description of The Position** The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and...

  • Patient Safety Specialist

    hace 2 semanas

    Bogota, Colombia Novartis A tiempo completo

    **Summary**: Monitorea y audita el programa de vigilancia de medicamentos, productos biológicos o dispositivos médicos de la compañía, incluida la ingesta, evaluación, procesamiento y seguimiento de informes adversos. Participa en la resolución de cualquier responsabilidad legal y en el cumplimiento de la normativa gubernamental. Garantiza una...

  • Senior Specialist, Quality Assurance Auditor

    hace 1 mes

    Bogota, Colombia Organon A tiempo completo

    Job DescriptionDescription of The PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution...

  • Senior Specialist, Quality Assurance Auditor

    hace 4 semanas

    Bogota, Colombia Organon A tiempo completo

    Job DescriptionDescription of The PositionThe Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution...

  • Drug Safety Scientist

    hace 1 mes

    Bogota, Colombia Organon A tiempo completo

    **The Position** - High performing senior specialist who leads signal detection, safety evaluation and risk management planning and activities for key Organon’s _highly complex_ medicinal products and/or medical devices during clinical development and/or for post-marketing PV setting from a scientific perspective by active participation and contribution...

  • Drug Safety Lead

    hace 1 mes

    Bogota, Colombia Organon A tiempo completo

    Job DescriptionThe PositionLeads signal detection, safety evaluation and risk management planning and activities for low-medium complex, medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective by active participation and contribution to, amongst others, the Organon Asset teams (when...

  • Drug Safety Lead

    hace 4 semanas

    Bogota, Colombia Organon A tiempo completo

    Job DescriptionThe PositionLeads signal detection, safety evaluation and risk management planning and activities for low-medium complex, medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective by active participation and contribution to, amongst others, the Organon Asset teams (when...