Drug Safety Specialist Position Available In Suffolk, Massachusetts

Drug Safety Specialist SGF Global Boston, MA 02133 • Hybrid work

Job Title:

Pharmacovigilance Specialist Location:

Boston, MA (Hybrid Role – 3 days/week in office) The Pharmacovigilance Specialist is responsible for day-to-day case management of adverse event records. This position assesses incoming communication to identify potential adverse event reports. The Pharmacovigilance Specialist provides medical evaluation of adverse event reports, compiles pharmacovigilance data, and analyzes and submits expedited reports to the FDA. The adverse event handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives. Key Responsibilities Evaluate incoming communication for potential adverse event reports via local intake system, phone, fax, mail, and other methods. Medically evaluate adverse event reports for seriousness and expedited reporting to FDA. Perform/coordinate follow-up activities to obtain missing and additional information required for case processing. Compile, evaluate, and submit serious and periodic reports to FDA. Ensure receipt of adverse events from marketing programs, license partners, and social media platforms. Perform monthly reconciliation activities. Support internal audits and external inspections. Maintain a current working knowledge of: Company policies and procedures, departmental processes, and associated work instructions Evolving local and international regulations, guidelines, and applicable directives Company products (product inserts, DFUs, promotional materials) Maintain and verify local database of complaint contacts/case tracking and management. Perform reconciliation with Medical Information, Product Quality, and License partner. Provide training to new employees about adverse event collection and reporting including training to call center vendors. Other duties as assigned. Skills & Qualifications Bachelor’s degree, preferably in healthcare or science discipline, is required. Healthcare education/certifications (e.g., RN, LVN, pharmacist) preferred. Two (2) to three (3) or more years of professional experience in a healthcare setting, pharmaceutical company, or supporting clinical trials required. Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance. Working knowledge of medical terminology, medical conditions, chemical structures/biological systems, and drug products. Familiarity with relevant computer software such as ARGUS or similar Drug Safety databases. Ability to prioritize, problem-solve, think critically, and multi-task under pressure. Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook. Good written and verbal communication skills. Strong organizational skills. Ability to work independently as well as collaboratively with a team.

Job Types:

Full-time, Contract Education:

Bachelor’s (Required)

Work Location:

In person