![Merck Sharp & Dohme](https://media.trabajo.org/img/noimg.jpg)
Sr. Spclst, Drug Safety
hace 2 semanas
The 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 standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle) ICH/GCP International Conference on Harmonization/Good Clinical Practice) and PV requirements.
The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP, and PV regulations and guidance.This position will focus on the development and maintenance of the Label Validation Files.
The Label Validation File contains adverse event (AE) terms that are considered expected (or referred to as "labeled") for a product and is created from the Reference Safety Information (RSI).
The RSI is used to determine regulatory reporting requirements of an adverse reaction.The LVF is incorporated into the regulatory safety system and enables the expedited reporting of cases that are suspected unexpected serious adverse reactions (SUSARs).
The maintenance of the LVF includes creating and updating company and non-company products, MedDRA Upgrades, and ad-Hoc requests.The role collaborates cross-functionally to understand the study configuration, check document readiness, submission to health authorities, and local country pharmacovigilance.
Key Responsibilities:
Creation and Maintenance of Label Validation Files
Cross-functional collaboration with key customers in GCS&PV such as Clinical Safety & Risk Management (CSRM), Medical Safety Review (MSR) & PV-O&GPE (PV-Operations & Global Process Enablement); and Global Clinical Trial Operations (GCTO), in support of end-to-end creation and maintenance of Label Validation Files
Represent CSSO on cross-functional teams and strategic initiatives
Participate in interdepartmental and interdivisional meetings to support Label Validation Files and provide input for operational and regulatory PV requirements, and related processes
Participate in cross-functional meetings to support the development of data collection deliverables
Collaborate with external colleagues, business partners, and vendors as needed
Support the development/update of process documents
Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable
Education:
Required:
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field or MD/DO/International equivalent
A minimum 3 years of work experience in pharmaceutical, clinical drug development, and/or drug safety experience required
Preferred:
Medical degree/DO/International equivalent with clinical experience
Required Skills:
Basic understanding of drug development
Basic knowledge of ICH, GCP, and PV regulations
Experience working as part of a cross-functional team setting
Effective problem-solving skills, can analyze an issue and develop and implement solutions with oversight
Project management, and time management/organizational skills
Plans and coordinates work activities with others to maximize results
Proactively seeks out advice and information from others when addressing business issues
Strong communication skills with advanced oral and written English skills
Strong computer and database skills, experience working with Microsoft Office tools
We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees
Current Contingent Workers
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R231861
-
Drug Safety Associate
hace 2 semanas
Bogotá, Bogotá D.E., Colombia ICON 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.- Receives and...
-
Drug Safety Lead
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob 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 2 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob 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 4 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob 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 2 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoThe 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 2 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoThe 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 Scientist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Merck A tiempo completoThe 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)....
-
Assoc. Spclst, Drug Safety
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob 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...
-
Drug Safety Scientist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob 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 4 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob 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 4 semanas
Bogotá, Bogotá D.E., Colombia Organon A tiempo completoJob DescriptionThe PositionSupports the Global Pharmacovigilance and Safety Science (GPSS) team in safety surveillance and risk management of established brand products and key new asset products.Authoring regulatory documents and aggregate safety reports with cross-functional collaboration.Assists with safety surveillance review activities of adverse...
-
Director, Drug Safety
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob 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...
-
Clinica Safety Scientist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob 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 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoIndividual 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...
-
Clinical Safety Scientist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob 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 2 semanas
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob 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...
-
Sr Rep, Safety
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Edwards Lifesciences A tiempo completoKey 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...
-
medical safety expert
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Abbott Laboratories A tiempo completoJob 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 4 semanas
Bogotá, Bogotá D.E., Colombia Abbott Laboratories A tiempo completoJob 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...
-
Sr Manager Global Process Safety
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Ingredion Incorporated (Corporate) A tiempo completoSenior Manager, Process Safety, Global Corporate EHSS FLEX LOCATION : BRAZIL, COLOMBIA, MEXICO OR PERU (fully remote work) REPORTS TO : Global Director, Corporate Health, Safety, Security & Process Safety The Senior Manager, Process Safety, is primarily responsible to mentor and support Global operations as needed to promote, develop and oversee...