Descripción del empleo
Join us on our exciting journey!
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Provide medical expertise on pharmacovigilance services to all Quinties divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
Represent safety and clinical data review findings during client meetings
Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
Provide medical oversight for label development, review and change
Provide medical support and attendance at Data Safety Monitoring Board Meetings
Attends and contributes medical safety evaluation on Safety Monitoring Committees
Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
Act as Global Safety Physician or Assistant or Back-up on projects as assigned
Attend project meetings, medical safety team meetings, and client meetings as requested
Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
Provide medical escalation support for medical information projects
Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
24 hour medical support as required on assigned projects
Maintain awareness of medical-safety-regulatory industry developments
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Pharmacovigilance / Medical Safety Experience is required
Fluency in English is a required
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
Knowledge of clinical trials and pharmaceutical research process
Ability to establish and meet priorities, deadlines, and objectives.
Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education and 5 years’ experience practicing clinical medicine after award of medical degree; or equivalent combination of education, training and experience; Graduate medical training can qualify for clinical practice experience; Three years of clinical practice experience with two additional years as a pharmaceutical physician in any role can also suffice.
- A valid medical license, or equivalent, from the country or region in which he/she resides and works
- Deep knowledge/experience of at least 2 years in Clinical Research including regulations/processes, Leadership/management experience, direct contacts with Sponsors (e.g. Bid-defence participation) experience and safety monitoring experience.
Extensive use of telephone, email, and face-to-face communication requiring accurate perception and elocution of spoken and written English
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
The ability to travel based on client or company needs,
- Carnet de conducir
- Carta de motivación