Safety Physician Home-Based in Europe
- Employer
- Syneos Health
- Location
- Europe
- Salary
- Competitive
- Start date
- 29 Oct 2020
- Closing date
- 28 Nov 2020
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- Discipline
- Clinical Research, Clinical Operations, Drug Safety
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
SUMMARY
The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs),
conducting medical assessment of all safety related data and ensuring medical accuracy of the ICSR
narrative, coding and appropriate medical interpretation of all cases.
JOB RESPONSIBILITIES
Performs medical review of adverse events reported for investigational and marketed products.
Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.
Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical
interpretation and consistency are applied to adverse event case assessment.
Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of
clinical and post-marketing safety information.
Identifies, communicates and effectively manages potential safety issues.
Interacts with client’s safety/medical personnel as appropriate.
Stays abreast of clinical and drug development information relevant to contracted programs.
Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports,
PSURs, PADERs).
Maintains medical and pharmacovigilance expertise through appropriate internal or external
continued medical education.
Assists as a mentor and trainer for other internal safety staff including case processing staff.
Responsible for performing activities that are in compliance with applicable Corporate and D
Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific
Operating Guidelines.
Performing other duties as assigned by management.
REQUIREMENTS
The incumbent should possess M.D., MBBS, D.O. or equivalent combination of education and
experience
Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working
in pharmacovigilance/epidemiology preferred
Knowledge of global pharmacovigilance regulations and processes
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook),
TeamShare (or other management/shared content/workspace), safety databases, and internet.
Excellent verbal and written communication skills (proficient in English) as well as in the language
required for case processing
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to
inform and influence
Ability to travel as necessary (up to 10%)
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
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