Pharmacovigilance Specialist


Job ID 18-00178

Industry Pharma

Job Type Permanent

Location East Windsor, NJ

Description

% OF TIME FREQUENCY ESSENTIAL DUTIES
20 Daily Processing and completing all the required documentation for any/all inquiries, product quality complaint, and or adverse drug event that is received via email, internal, external sources. This includes inputting ADE cases in Argus
20 Daily Conducting follow-ups for Product complaints and ADEs by interacting with the customer or complainant to acquire further information that may be required to effectively resolve the customer concern
30 Daily Forwarding all cases received domestically via the drug safety database, ARGUS, or manually in a timely manner to ensure timely case assessment. Assisting in conducting follow-up for ADE cases received domestically, and as per GPvD deems appropriate. When deemed appropriate, ensuring that all ADE cases are processed without delay and in accordance with current SOPs and FDA guidelines
20 Daily Assist the Pharmacovigilance Manager and other functional teams to compile REMS submissions and reports to the Food and Drug Administration (FDA) for approval and attend REMS program meetings with vendors or regulators as necessary to ensure vendor compliance with established programs
10 Monthly Maintain and update SDEA templates for co-licensing partners, distributors, service providers and wholesalers in line with internal processes and procedures. Work alongside Quality to ensure awareness of TAs (Technical Agreements) impacting PVG

OTHER RESPONSIBILITIES
Additional dutoes may be assigned depending on the work load of the department



Qualifications

QUALIFICATIONS PREFERRED & REQUIRED
BS/BA in a health or biological science discipline (or licensed certification) and clinical experience as a health care professional. 2-3 years relevant experience in clinical safety/pharmacovigilance with a concentration of experience in clinical safety activities. Very strong written and verbal communication skills. Working knowledge of Microsoft Word, Excel and PowerPoint. Critical thinker, intellectually creative and with ability to synthesize, analyze and critique data.