Safety Physician - Home Based Europe
Syneos Health
Based, Home, BEL, Belgium
3 dagen geleden

SUMMARY

The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs),

conducting medical assessement 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.

Qualifications

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%)

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