Assoc. Spclst, Drug Safety

hace 3 semanas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

Job Description:


The Associate Specialist, PV is responsible for undertaking specified PV activities including projects with oversight by their manager or a designated PV colleague.


The items listed below are activities that can be performed by the role and is applicable for all supported countries. Additional local specific tasks and responsibilities may be further described in the section below entitled "Additional Local Specific Activities".


Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.

Assists with 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.

Assists with Individual Case Safety Report (ICSR)

Health Authority submissions in accordance with company procedures and health authority requirements, when requested.

Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested.

Responsible for filing (electronic, paper), storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports. Supports local PV audits and inspections when requested. Supports PV self-inspections as required by PV Legislations (where applicable). 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 01:
Patient Safety.

Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.

May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system.

May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.

Support local implementation of applicable business continuity plans (as applicable). Performs other activities as requested by their Manager. May participate on special projects or rotational assignments within or outside of IPV as part of their professional development.

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R253257

  • Sr. Spclst, Drug Safety

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Merck Sharp & Dohme A tiempo completo

    Job DescriptionThe Senior Specialist within the PV-operations Clinical Safety Strategy Operations team collaborates with MRL colleagues to provide operational and regulatory pharmacovigilance (PV) input for company processes and standards and software system configuration that impact trial adverse event (AE) reporting and management. Maintains PV global...

  • Drug Safety Associate

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia ICON A tiempo completo

    As a Drug Safety Associate you will be joining the world' s largest & most comprehensive clinical research organization, powered by healthcare intelligence.What you will be doing:A Drug Safety Associate is a professional who is an integral part of drug development lifecycles to collect accurate safety information and to ensure patient safety.- Receives and...

  • Drug Safety Lead

    hace 3 semanas

    Bogotá, Bogotá D.E., 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 3 semanas

    Bogotá, Bogotá D.E., 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 1 mes

    Bogotá, Bogotá D.E., 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 Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., 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 postmarketing PV setting from a scientific perspective by active participation and contribution to, amongst...

  • Drug Safety Lead

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Organon A tiempo completo

    The Position Leads signal detection, safety evaluation and risk management planning and activities for lowmedium 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 available) Risk...

  • Drug Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Merck A tiempo completo

    The Position Supports the Global Pharmacovigilance and Safety Science (GPSS) team in the safety surveillance (e.g., signaling) and risk management (routine as well as additional risk minimization measures, Risk Management Planning) of assigned, more complex established brands products and/or key new asset products (devices and/or medicinal products)....

  • Drug Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Organon A tiempo completo

    Job DescriptionThe PositionSupports the Global Pharmacovigilance and Safety Science (GPSS) team in the safety surveillance (e.g., signaling) and risk management (routine – as well as additional risk minimization measures, Risk Management Planning) of assigned, more complex established brands products and/or key new asset products (devices and/or medicinal...

  • Drug Safety Scientist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Organon A tiempo completo

    Job DescriptionThe PositionSupports the Global Pharmacovigilance and Safety Science (GPSS) team in the safety surveillance (e.g., signaling) and risk management (routine – as well as additional risk minimization measures, Risk Management Planning) of assigned, more complex established brands products and/or key new asset products (devices and/or medicinal...

  • Director, Drug Safety

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job Description:The Director provides dynamic leadership and strategic direction with regards to high quality and excellent compliance of individual case safety reports (ICSRs) and, the performance and results of the Medical Safety Review (MSR) Physicians in the US and globally. This role has responsibilities for ensuring operational and scientific...

  • Clinical Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Individual Case Medical Review (ICMR)The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for...

  • Clinica Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job Description:Individual Case Medical Review (ICMR)The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting...

  • Clinical Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job Description:The Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late stage development.Key responsibilities: Intake of reportable safety event information from clinical trial investigator sites...

  • Clinical Safety Scientist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job Description:Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and...

  • medical safety expert

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Abbott Laboratories A tiempo completo

    Job TitleMEDICAL SAFETY EXPERT About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self...

  • medical safety expert

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Abbott Laboratories A tiempo completo

    Job TitleMEDICAL SAFETY EXPERT About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self...

  • Assoc. Spclst, Quality Assurance

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Merck A tiempo completo

    Descripción del Puesto/de la PosiciónLa persona será encargada de dar soporte al área de In Market Quality con el fin de mantener un sistema de calidad efectivo y alineado a regulaciones locales y Procedimientos globales corporativos.Responsabilidades Soporte en el desarrollo y mantenimiento del sistema de gestión de calidad local para asegurar con...

  • Sr Rep, Safety

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Edwards Lifesciences A tiempo completo

    Key Tasks under the role:Manage Personal Protective Equipment (PPE) inventory in coordination with cross-functional teams (e.g., Sales & Clinical Team) including purchasing new PPE, conduct training on the use of PPE's (Bio Safety Training), and inspect equipment for damages on an annual basis.Review monthly radiation control report, monthly dosimeter...

  • Nurse Medical Information Specialist Services

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia CONDUENT A tiempo completo

    Sobre Conduent: Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where...