Drug Safety Scientist
hace 8 meses
**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).
- Authoring (drafts) of regulatory documents and aggregate safety reports with cross-functional collaboration, including but not limited to Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Renewal documents.
- In addition, with guidance from Global Medical Safety (GMS) team, assists with the safety surveillance review /signaling activities of individual adverse experience (AE) reports including the individual Device Adverse Event (DAE) reports, aggregate individual case safety report (ICSR) reviews, and with the development and evaluation of risk management plans (RMPs) and the various risk management files related to devices.
- GMS expert with primary ownership of designated products and/or medical devices. As an Associate Principal Scientist, overall independence, knowhow for safety surveillance/ pharmacovigilance and epidemiologic principles to complete signal detection, evaluation, and risk management process for assigned products throughout their life cycle and resourcefulness in all tasks and processes related to the products' safety surveillance and risk management are expected.
**Organizational Relationships**
- Under the general direction of the Drug Safety Scientists Lead
**Primary Responsibilities**
- Accountable for
- Maintaining product specific documents including but not limited to V-cards, product-specific MedDRA coding instructions, and follow-up (FU) questionnaires.
- Safety data retrieval, analysis and cross functional communication.
- Responsible
- for Signal management timelines and quality of activities (including documentation).
- to take over activities of new medicinal product/device integration if applicable.
- Contributes, if agreed to;
- The Risk Management Safety Team (RMST) and supports the RMST lead by expert evaluation of literature and other aggregates data, signal validation and evaluation, Health Authority Response to Questions (RTQ) documents.
- The creation of Aggregate Safety Reports (ASR) and Risk Management Plans (RMPs).
- Health Hazard Evaluations (HHE) and Medical Assessment Memos (MAMs).
- Company Core Data Sheet (CCDS)/Company Core Safety Information (CCSI) and key local labels (e.g., Summary of Product Characteristic [SPC], United States Prescribing Information [USPI], Patient Information Leaflet [PIL]).
- Safety related activities of clinical studies (protocol, Investigator’s Brochure [IB] including Reference Safety Information [RSI], Informed Consent Form [ICF], and Clinical Evaluation Report [CSR]) as agreed with the DSL.
- The development and/or implementation of Additional Risk Minimisation Measures (ARMMs).
- Timely response to internal and external (other than Health Authority) requests e.g., legal, Regulatory Development Review Committee (RDRC), medical information, business partners, affiliates).
- Technical Review Committee (TRC) 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**
- Leads the quality assurance of prepared responses to inquiries from health professionals, regulatory agencies and other stakeholders regarding adverse experiences reported products in preclinical, clinical, and post-marketed phases of development.
- Periodic review of AE reports at an individual and aggregate level, including presentation of safety data to the RMST.
- Continuously assess the benefit-risk profile at every stage of the medicine’s development and for the entire time the medicine is on the market.
- In collaboration with DSL, for timely response to requests posed by internal stakeholders.
- Active participation and contribution to product RMST.
- Authoring, in collaboration with the GPSS team, and with strategic guidance from the Therapeutic Area (TA) lead, of agency responses and regulatory documents, including but not limited to PSURs, DSURs, RMPs, Investigational New Drug (IND) and New Drug Application (NDA) Annual Safety Reports, Periodic Adverse Experience Reports (PAERs), Clinical Evaluation Report (CER), Product Renewal’s documentation and Clinical Overviews, as well as contributes to authoring and updating the Company product's labeling. In addition, conducts literature reviews, identifies background population rates and summarizes and interprets relevant findings to support regulatory responses, health authority commitments, and PSURs.
- Supports the submission process for regulatory documents and publications.
- Collaborating with GPSS and the appropriate functional areas, and with strategic guidance from the TA head, revi
-
Drug Safety Scientist
hace 7 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...
-
Clinical Safety Scientist
hace 6 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...
-
Drug Safety Lead
hace 7 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...
-
Drug Safety Associate
hace 6 meses
Bogota, Colombia ICON plc A tiempo completoAs 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.-...
-
Specialist, Drug Safety
hace 6 meses
Bogota, Colombia MSD A tiempo completoThe 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...
-
Assoc. Spclst, Drug Safety
hace 6 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...
-
Medical Safety Expert
hace 6 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...
-
Nurse Medical Information Specialist Services
hace 6 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...
-
Nlp Engineer
hace 7 meses
Bogota, Colombia Keller Executive Search A tiempo completoAs an NLP Engineer in their AI Labs, you will be responsible for bringing the latest innovations in ML research to the company. The mission of the department is to discover, architect, design, and refine solutions for the fields of Drug Discovery, Clinical Trials, Factory Automation, Medical Research, among others. **Specific Responsibilities**: - Design,...
-
Global Pharmacovigilance
hace 6 meses
Bogota, Colombia Abbott Laboratories A tiempo completo**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 family, be your true self, and live a...
-
Service Technician I
hace 6 meses
Bogota, Colombia EcoLab A tiempo completoJoin Ecolab’s industry leading Food & Beverage team as a **Service Technician**. We are increasing food safety and product quality, enhancing sustainability and boosting operational efficiency. We provide cleaning and sanitation solutions to food, beverage, and dairy manufacturing environments through a dual focus on sales and technical...
-
Production Associate
hace 6 meses
Bogota, Colombia Ecolab A tiempo completoEcolab, 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 ability to perform...
-
Production Associate
hace 6 meses
Bogota, Colombia EcoLab A tiempo completoEcolab, 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 ability to perform...
-
Director Medical Affairs
hace 6 meses
Bogota, Colombia IPSEN A tiempo completo**Title**: Director Medical Affairs **Company**: Ipsen Pharma (SAS) **Define the strategy for Medical Affairs locally and execute it**: - Create and implement strategic and operational plans in the country in line with the mission, strategy, and values of the Ipsen Group, thus achieving Global Medical Affairs and Local targets. - Secure the successful...
-
Mgr-human Resources I
hace 6 meses
Bogota, Colombia Marriott International, Inc A tiempo completo**Job Number** 24088499 **Job Category** Human Resources **Location** W Bogota, Avenida Carrera 9 #115 - 30, Bogota, Capital District, Colombia VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Management **JOB SUMMARY** As a member of the property Human Resources support staff, he/she works with Human...
-
Project Engineer I
hace 6 meses
Bogota, Colombia Schweitzer Engineering Laboratories A tiempo completoEssential Duties and Responsibilities_ 1. Possesses, understands and applies knowledge and experience of power system _focus area* _and related SEL products to complete complex assignments. 2. Lead in training and assisting customers with the creation, design configuration, validation, installation, commissioning and operation of automation and/or...
-
Project Engineer I
hace 6 meses
Bogota, Colombia Schweitzer Engineering Laboratories A tiempo completoEssential Duties and Responsibilities_ 1. Possesses, understands and applies the fundamental concepts, practices and procedures of power system focus area* and related SEL products. 2. Train and assist customers with the creation, design, configuration, validation, installation, commissioning and operation of automation and/or protection systems. 3....
-
Sma I
hace 6 meses
Bogota, Colombia ICON A tiempo completoAs a Site Management Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most...
-
Rep Ii
hace 6 meses
Bogota, Colombia Cencora A tiempo completo- What you will be doing - (_RESUMEN DE LA POSICIÓN_): 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. - (Prepara y gestiona los pedidos de envío de los clientes a nível nacional e...
-
Executive Assistant
hace 6 meses
Bogota, Colombia Emapta A tiempo completo**Job Information**: Work Arrangement **Permanent WFH** *** City **Bogota** *** State/Province **Distrito Capital de Bogotá** *** Country **Colombia** *** **Join the Heartbeat of Industrial Supply Chain - Embrace Global Opportunities Today!** Embark on a unique journey as the Executive Assistant to our client’s visionary CEO. This role offers...