Drug Safety Specialist

Location: Waltham, MA
Duration: 6-month
Schedule: hybrid – 3 days on site per week 

Summary

The Drug Safety Specialist supports clinical and post-marketing pharmacovigilance activities for investigational and marketed products. This position is responsible for adverse event case processing, safety surveillance, vendor coordination, and supporting cross-functional clinical teams while ensuring compliance with FDA, ICH, GCP, and company pharmacovigilance procedures.

Primary Responsibilities

Case Processing (50%)

• Process adverse event reports from receipt through case closure for clinical trial and post-marketing products.
• Review, evaluate, code, and report SAEs, SUSARs, and adverse events in accordance with FDA, ICH, and company SOPs.
• Perform MedDRA coding, narrative writing, medical history/medication coding, and quality review.
• Follow up on incomplete cases to ensure timely reconciliation and closure.
• Perform SAE reconciliation and maintain high-quality safety data.
• Support ongoing safety surveillance and assist with aggregate safety reviews and events of special interest.

Vendor & Cross-Functional Coordination (25%)

• Serve as the pharmacovigilance representative between CROs, vendors, investigator sites, and internal stakeholders.
• Collaborate with Clinical Operations, Regulatory Affairs, Medical Information, Data Management, Biostatistics, Quality, Product Development, and Legal.
• Coordinate external safety reporting activities and ensure vendor compliance.

Clinical Project Support (25%)

• Participate on clinical project teams supporting ongoing studies.
• Review study documents and provide safety-related feedback.
• Assist with Safety Management Plans and pharmacovigilance processes for assigned studies.
• Support regulatory submissions including IND Safety Reports, Annual Safety Reports, PSURs, Clinical Study Reports, and responses to health authority inquiries.
• Contribute to SOP development and continuous process improvements.

Must-Have Qualifications

• BS in Pharmacy, PharmD, RN, BSN, or other clinical degree.
• 3–5 years of drug safety or clinical safety experience.
• Clinical trial pharmacovigilance experience.
• Experience processing adverse event cases (ICSRs, SAEs, SUSARs).
• Knowledge of FDA, ICH, GCP, and global pharmacovigilance regulations.
• Experience with safety databases.
• Strong cross-functional communication skills.
• Ability to work independently while managing multiple priorities.

Preferred Qualifications

• Oncology case processing experience.
• Experience with Argus, ArisG, Clintrace, or similar safety databases.
• Experience with aggregate reports (DSURs, PSURs, IND Annual Reports).
• Vendor/CRO oversight experience.
• SOP development and Safety Management Plan experience.
• Inspection and audit readiness experience.