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Pharmaceutical Safety Medical Evaluation

Company Name:
Digital Action, Inc.
Our client is one of the world's leading privately held international specialty pharmaceutical and medical device companies. This role provides medical review and evaluation of safety information and adverse event reports for both marketed and investigational medicinal products and medical devices. Performs scientific review and evaluation of single and aggregate adverse events reports, and assesses them in accordance with appropriate regulations/guidelines and internal procedures.
Competencies:
Solid clinical experience, pharmacological background and medical knowledge of methods to assess causality relationship between the adverse drug experiences and the administration of Company products and to evaluate adverse events against core and local labeling.
Ability to interpret complex safety data and to effectively synthesize and communicate scientific information
Effective oral and written communication skills
Effectiveness in cooperation and teamwork
Knowledge of MedDRA
Knowledge of safety database. Good working knowledge of computer technology desirable.
Knowledge of CFR and ICH Guidelines for drug safety surveillance and medical device reporting
Analytical and problem solving skills
Attention to details

EDUCATION and/or EXPERIENCE REQUIRED:
Medical degree with clinical experience, with certification in clinical pharmacology or an internal medicine discipline or public health
Post graduate medical training and/or epidemiology experience highly preferred
A minimum of 5 years' experience in pharmaceutical industry within medical affairs department, with at least 2 years in drug safety

Please contact Ken Diamond at 610-941-0700 for a confidential discussion or email kjdiamond@digital-action.com with resume and cover letter.

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