Sr. Drug Safety Analyst (50497189) Stamford, Connecticut

Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations. Develops and contributes Subject Matter Expertise in various safety case management functions. PRINCIPAL ACCOUNTABILITIES:
-All DS Analyst responsibilities
-Assist with review of scientific literature articles when required
-Assist with advanced case processing activities (merging cases, deletion, distribution to other companies, etc.)
-Assist in receiving and documenting incoming calls and performing follow-up (AE and PC)
-Coach and act as Subject Matter Expert for Analysts
-Assume project responsibility as assigned

Educational Requirements

RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related degree required, or Associates degree in a relevant field with commensurate Drug Safety experience.

Required Experience & Technical Requirements

Technical Requirements
-2 - 4 years of experience in a pharmaceutical company or clinical environment required
-Minimum 1 year Drug Safety experience required
-Working knowledge of FDA and international regulations
-Data entry and computer skills
-Proficiency with basic MS Office applications and experience with relational safety database
-Working knowledge of scientific terms and medical terminology
-Working knowledge of MedDRA
-Written and verbal communication skills; interpersonal skills
-Organization skills; analytical thinking
-Time management and ability to prioritize workload
-Quality orientation: attention to detail, accuracy
-Advanced understanding of safety processes
-Understanding of documentation requirements in regulated environment Preferred skills:
-Argus Safety knowledge

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