Empleos actuales relacionados con Drug Safety Scientist - Bogotá, Bogotá D.E. - Organon

  • Global Pharmacovigilance Specialist

    hace 4 semanas

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

    Position Overview This role is situated within the Established Pharmaceuticals division and focuses on enhancing the safety profile of our diverse portfolio of high-quality branded generic medications. At Abbott, we are dedicated to expanding access to our trusted therapies in rapidly growing markets. Our extensive range of medicines addresses various...

  • Global Pharmacovigilance Specialist

    hace 4 semanas

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

    Opportunity Overview This role is situated within the Established Pharmaceuticals division at Abbott, focusing on enhancing the safety of our pharmaceutical offerings. Our mission is to extend the reach of our trusted medications to a broader audience in rapidly developing markets. We maintain a diverse portfolio of high-quality branded generic...

  • Global Pharmacovigilance Specialist

    hace 4 semanas

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

    Position Overview This role is integral to our division focusing on Established Pharmaceuticals. We are dedicated to expanding access to our reliable medications in rapidly developing markets. Our extensive range of high-quality branded generic medicines spans various therapeutic fields, including gastroenterology, women's health, cardiometabolic...

  • Manufacturing Team Member

    hace 4 semanas

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

    Position Overview: Ecolab, a global leader in the development of premium cleaning, sanitizing, and maintenance solutions for various markets, is in search of a Production Associate. This role entails managing all facets of operation, filling, packaging, and tote washing. Candidates should be equipped to handle a variety of tasks within the production...

  • Manufacturing Operator

    hace 4 semanas

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

    Position Overview: Ecolab, a global leader in premium cleaning, sanitizing, and maintenance solutions for various markets, is in search of a Production Associate. This role encompasses the comprehensive operation, filling, packaging, and washing of totes. Candidates should possess the capability to undertake various tasks within the production sector,...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    Company Overview: Galderma stands as a leader in dermatology, with a legacy of innovation and a presence in around 90 countries. Our commitment to delivering a science-driven portfolio of premium brands and services spans the dynamic dermatology market, encompassing Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our inception in...

  • Manufacturing Operations Associate

    hace 4 semanas

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

    Position Overview: Ecolab, a global leader in the development of high-quality cleaning, sanitizing, and maintenance solutions for various sectors, is looking for a Production Associate. This role encompasses the full spectrum of tasks related to operating, filling, packaging, and washing totes. Candidates should be prepared to engage in multiple functions...

  • Pharmacovigilance and Regulatory Affairs Specialist

    hace 6 días

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

    Job DescriptionOrganon is seeking a highly skilled Pharmacovigilance and Regulatory Affairs Specialist to join our team in Colombia. As a key member of our Regulatory Affairs and Pharmacovigilance department, you will be responsible for ensuring compliance with local laws and regulations, managing Pharmacovigilance submission requirements, and executing...

  • Icmr - Clinical Safety Scientist (Css)

    hace 2 semanas

    Bogotá, Cundinamarca, 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...

  • Global Medical Safety Expert

    hace 1 mes

    Bogotá, Cundinamarca, Colombia Abbott Laboratories A tiempo completo

    **Job Title** **Global 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...

  • Medical Scientific Liaison

    hace 1 mes

    Bogotá, Cundinamarca, Colombia Bayer A tiempo completo

    **Medical Scientific Liaison** **TASKS AND RESPONSIBILITIES** - Exchange and dissemination of scientific, educational, and research related information: The MSL plans, prepares and engages with KOLs as an information scientist and colleague both proactively and reactively via various innovative KOL engagements tactics and formats to provide dissemination,...

  • Production Associate

    hace 4 meses

    Bogotá, Colombia Ecolab A tiempo completo

    JOB DESCRIPTION Ecolab, the leading global developer of premium cleaning, sanitizing and maintenance products and services for the hospitality, institutional and industrial markets is seeking a Production Associate  who will be responsible for all aspects of operating, filling, packaging, and tote washing. Incumbents in this position should have the...

  • Service Coord. Specialist

    hace 2 meses

    Bogotá, Colombia SAN Fortrea Chile Limitada A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Rep II

    hace 7 días

    Bogotá, Colombia World Courier de Colombia S.A. A tiempo completo

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Rep II

    hace 7 días

    Bogotá, Colombia World Courier Inc A tiempo completo

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

Drug Safety Scientist

hace 3 meses

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 others, the Organon Asset teams, Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST and other safety related decision making governance bodies. Safeguard patient from harm.
  • Lead Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
  • Lead the safety contributions to global regulatory submissions.
  • Ensure that appropriate safety objectives and risk minimization strategies are included in clinical development programs and shows confidence, credibility and influence at all levels of the organization.
  • Expert evaluation for literature review, clinical data synthesis, analysis, and interpretation.
  • Ensure that the scientific safety assessment of individual development assets is driven by comprehensive and customerfocused strategic patient safety expertise, for effective benefitrisk decisionmaking.

Responsibilities
Accountable for

  • Signal management of assigned products, timely handling of signal evaluations and benefit/risk assessments for assigned products and signal detection escalation level for drug safety scientist.
  • CCDS/CCSI and key local labels (SPC, USPI, PIL) safety sections.
  • Risk management planning (RMP) and Additional Risk Minimization Measures (ARMM) development and execution.
Responsible for

  • Evaluation strategies and RMST presentations as well as adequate documentation.
  • The creation of Aggregate Safety Reports (ASR) and Risk Management Plans (RMP) i.e. data completeness, accuracy and timely submission to GRA publishing.
  • PQC risk assessment evaluation strategies and presentations i.e. generation of Health Hazard Evaluations (HHE) and MAMs.
  • When applicable (less complex product in postmarketing or new straight forward developmental asset), Safety related activities of clinical studies (protocol, IB including RSI, ICF, CSR).
  • Evaluation strategy, presentations and timely response to internal and external (other than Health Authority) requests e.g. legal, RDRC, medical information, business partners, affiliates).
  • To take over activities of new medicinal product/device integration if applicable.
Contributes to

  • Technical Review Committee (TRC), Developmental Review Committee (DRC), NORSAP, if applicable and RDRC activities.
  • The onboarding curriculum and/or materials for new staff.
  • IT system selection, user requirements testing and providing user support, when requested.
Tasks

  • Under the general direction of the Therapeutic Area Lead, partners with cross functional teams to ensure efforts are aligned to meet global risk management strategies for assigned products.
  • May chair the RMST, upon request TA lead for assigned products and includes review of data analysis, review of presentation slide decks, review of RMST post meeting notes (PMN) and checking process compliance.
  • Supports Clinical Development/Regulatory Affairs/Affiliates on ad hoc questions concerning medical / clinical safety (expert reports, regulatory dossiers).
  • Ensures escalation of emerging safety issues or significant safety signals qualifying for urgent notification to Heath Authorities are investigated in a timely manner and as per the urgent potential safety issue (UPSI) process.
  • Ensures that patient risk reduction strategies are included in relevant documents such as clinical study protocols, study reports, informed consent forms and SmPC/Patient Leaflet before going to TRC/DRC.
  • Involvement in the correct communication and information on drug safety topics, in particular drug safety review of promotional and medical affairs material.
  • Ensures in close collaboration with Clinical Operations and Clinical Development, the exchange of all safety relevant information between the Global Pharmacovigilance (GPV) Department Organon and involved CROs for all clinical development projects is organized.
  • Responsible, in close collaboration with Clinical Operations and involved CROs, for the review/preparation of individual safety reports (incl. SUSARs) and reports of aggregated clinical data (Annual Safety Reports/Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees and external Safety Review Boards.
  • Oversees programs and registries safety related compliance, including the monitoring and followup of reports in special programs such as pregnancy registries, Patient support programs, market research, prelicense access programs, digital health solutions if appropriate.
  • MedDRA updates for assigned products twice per year.
  • Creation and/or maintenance of targeted