Specialist, Drug Safety

hace 5 meses

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 diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with mínimal supervision.

Activities:
1. Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.

2. If serving as the local QPPV / Local PV Contact / Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations.

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

4. 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.

5. 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.

6. May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).

7. Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.

8. Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.

9. Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.

10. May support PV Lead in maintaining the local PV Training matrix and onboarding plans.

11. May support development and maintenance of local PV controlled documents (i.e., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.

12. Supports PV self-inspections as required by PV Legislations (where applicable).

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

14. Supports training of local company staff, distributors, vendors, and business partners as instructed by their manager.

15. Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

16. May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).

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

18. As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).

19. May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.

20. As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).

21. 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.

22. As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).

23. Support local implementation of applicable business continuity plans (as applicable)

24. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

25. Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures.

26. Liaises with the local bus

  • Drug Safety Scientist

    hace 6 meses

    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 Associate

    hace 5 meses

    Bogota, Colombia ICON plc 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.-...

  • Drug Safety Scientist

    hace 7 meses

    Bogota, 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...

  • Drug Safety Lead

    hace 6 meses

    Bogota, Colombia Organon A tiempo completo

    **The Position** - Leads 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...

  • Director, Drug Safety

    hace 5 meses

    Bogota, 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 5 meses

    Bogota, 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 5 meses

    Bogota, 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...

  • Assoc. Spclst, Drug Safety

    hace 5 meses

    Bogota, 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...

  • Safety Data Specialist

    hace 5 meses

    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...

  • Safety Data Specialist

    hace 2 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...

  • Sr. Specialist Safety

    hace 5 meses

    Bogota, Colombia MSD A tiempo completo

    We are looking for a Sr. Specialist Global Safety & Environment, reporting to the Manager Safety & Environment of LATAM, the Sr. Specialist is responsible for managing the development and implementation of environmental, health and safety programs for Commercial Operations (Fleet Safety, Offices and Warehouses) including both field sales and office...

  • Medical Safety Expert

    hace 5 meses

    Bogota, Colombia Abbott Laboratories A tiempo completo

    **Job Title** **MEDICAL SAFETY EXPERT** **About Abbott** Abbott 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...

  • Safety Admin

    hace 5 meses

    Bogota, Colombia Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Safety Service Delivery Specialist

    hace 5 meses

    Bogota, Colombia DiDi Global A tiempo completo

    Company Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...

  • Manager Security

    hace 5 meses

    Bogota, Colombia Philip Morris International A tiempo completo

    Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and...

  • EHS Specialist

    hace 5 meses

    Bogota, Colombia JLL A tiempo completo

    JLL supports the Whole You, personally and professionally. **Benefits to eligible employees, include**: Medical and life insurance for you. Annual Performance Bonus. Online platform with +15.000 certified courses available for your professional development. Wellbeing platform for employees with personalized programs (yoga, meditation, exercise, meal...

  • Nurse Medical Information Specialist Services

    hace 5 meses

    Bogota, 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...

  • Protection From Violence Specialist

    hace 5 meses

    Bogota, Colombia Norwegian Refugee Council A tiempo completo

    The Norwegian Refugee Council (NRC) seeks a dedicated **Protection from Violence (PfV) Specialist **to lead our efforts in ensuring safety and protection for those affected by violence in **Colombia, Ecuador, and Panama **. This role is crucial in developing **strategic direction, ensuring program quality, **identifying priority protection issues, **and...

  • Safety Service Delivery Specialist

    hace 5 meses

    Bogota, Colombia DiDi Global A tiempo completo

    Company Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...

  • Telecommunications Specialist

    hace 5 meses

    Bogota, Colombia U.S. Department of Justice A tiempo completo

    Summary This position is located in the Drug Enforcement Administration (DEA), Bogota, Colombia Country Office. This job is open to Career transition (CTAP, ICTAP, RPL) Federal employees who meet the definition of a "surplus" or "displaced" employee. Internal to an agency Current federal employees of this agency. Clarification from the agency Current...