Drug Safety Associate

hace 3 meses


Bogotá Cundinamarca, Colombia ICON A tiempo completo

As a Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

**What you will be doing**:
- Receives and processes individual case safety reports ((ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports. This includes: Tracking of received ICSR, entry of ICSR into company or client safety database and query management.- Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.- Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.- Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement.- Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.- Supports interim data analysis for DMC reviews.- Receives inquiries from consumers or healthcare professionals in support of marketed
- products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions.

**You are**:
- Bachelor’s degree in a health, life sciences or other relevant field of study.- All employees must read, write and speak fluent English and host country language.

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.



  • Bogotá, Colombia MSD A tiempo completo

    The Clinical Safety and Risk Management Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned marketed drugs/vaccines. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide...


  • Bogotá, Colombia Merck Gruppe - MSD Sharp & Dohme A tiempo completo

    Job Description The Clinical Safety and Risk Management Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned marketed drugs/vaccines. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety...


  • Bogotá, Colombia Buscojobs Colombia A tiempo completo

    The Clinical Safety and Risk Management Physician is an expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned marketed drugs/vaccines. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in...


  • Bogotá, Cundinamarca, Colombia Velocity Global A tiempo completo

    We are looking for a Health & Safety Associate to join the Health and Safety section of our Subsidiary Management and Corporate Governance team. You will provide administrative support to the team, ensuring compliance with all relevant regulations, maintaining safety records, and assisting in the implementation of safety programs and procedures across the...


  • Bogotá, Colombia Buscojobs Colombia A tiempo completo

    Clinical data and pharmacovigilance associate COP 40.000.000 - 80.000.000 Clinical Data and Pharmacovigilance Associate About the Company: IGC Pharma SAS is based in Bogota and is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company that focuses on preventing and managing Alzheimer’s and other CNS diseases. We are...


  • Bogotá, Colombia ML Colombia S.A. A tiempo completo

    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 individuality is...


  • Bogotá, Cundinamarca, Colombia United Nations A tiempo completo

    Org. Setting and Reporting - This position is located in the Aviation Unit/Service Deliver Section of the United Nations Verification Mission in Colombia (UNVMC). The incumbent will be based in Bogota and will report to the Chief of Unit, Air Operations. - Responsibilities - Air Operations Centre (Unit) duties: - Monitors that air operations are conducted in...

  • Associate Director

    hace 4 meses


    Bogotá, Cundinamarca, Colombia Mace A tiempo completo

    **Associate** Director **- Project Controls** At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture and priorities, visit our strategy site. Within our Consult...

  • Sr Pay Associate

    hace 4 meses


    Bogotá, Cundinamarca, Colombia Fortrea 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...


  • Tocancipá, Cundinamarca, Colombia ChemTreat A tiempo completo

    Carry out the repair, conservation and maintenance of the facilities, equipment, vehicles and furniture; In addition to carrying out the activities of Preventive and Corrective Maintenance of plant equipment, within the guidelines and regulations established by LIPESA COLOMBIA S.A.S. Support the manufacturing process of chemical products and activities...


  • Bogotá, Cundinamarca, Colombia Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life **:As an Associate Quality Systems Specialist, you will have responsibility for development of...


  • Bogotá, Cundinamarca, Colombia J.S. Held LLC A tiempo completo

    **Company Description** Are you looking to join an organization that is growing and dynamic? What about a high-energy, collaborative environment that rewards hard work?** J.S. Held is a global consulting firm that combines technical, scientific, financial, and strategic expertise to advise clients seeking to realize value and mitigate risk. Our...


  • Bogotá, Colombia INGEPSY A tiempo completo

    At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture, and priorities, visit our. Within our consult business we harness our unique combination of leading-edge...

  • Rep Ii

    hace 4 meses


    Bogotá, Cundinamarca, Colombia Cencora A tiempo completo

    **Job Details**: - Job Description***: Prepares, and manages clients’ shipping orders domestically and internationally. Main duties include reviewing shipment requirements to ensure shipments are promptly processed and proactively communicating updates. **PRIMARY DUTIES AND RESPONSIBILITIES**: **Level II - Shipment Types** Drug/Biological domestic,...

  • Service Technician Ii

    hace 2 días


    Bogotá, Colombia Ecolab A tiempo completo

    Ecolab is seeking a **Service Technician** to join its industry leading Food & Beverage team. This is an entry level sales position responsible for selling Food & Beverage products/services by interacting with established customers and developing new sales prospects. We are increasing food safety and product quality, enhancing sustainability and boosting...


  • Bogotá, Bogotá D.E., Colombia Everise A tiempo completo

    Company OverviewEverise is a global experience company that believes in being people-first, celebrating diversity, and incubating innovation. Our dedication to our purpose and people has been recognized by our employees and the industry, with a 4.6/5 rating on Glassdoor and multiple Best Place to Work awards.Qualifications:We are looking for a...


  • Bogotá, Cundinamarca, Colombia PSI CRO A tiempo completo

    **Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...


  • Bogotá, Colombia ENGINEERINGUK A tiempo completo

    You will need to login before you can apply for a job. Site Management Associate (Senior and level I) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...


  • Bogotá, Cundinamarca, Colombia MSD A tiempo completo

    Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP,...


  • Bogotá, Cundinamarca, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...