Drug Safety Specialist

Job Title: Pharmacovigilance Specialist / Drug Safety Associate

Location: Plainsboro, NJ (Onsite; occasional remote work may be permitted with manager approval)

Duration: 6-Months Contract

Schedule: Monday – Friday, 8:30 AM – 5:00 PM (up to 40 hours/week)

Required Skills:

• Bachelor's degree in a medical, scientific, or related discipline (or equivalent relevant experience, such as a Registered Nurse with clinical experience).
• Minimum 2 years of pharmacovigilance experience, including MedDRA coding and adverse event identification.
• Strong knowledge of medical and pharmacovigilance terminology.

Job Summary:

Responsible for receiving, processing, triaging, and assessing the quality of inbound safety information, including adverse events and technical complaints for marketed and investigational pharmaceutical and medical device products. Ensures compliance with internal procedures and external regulatory requirements related to drug and device safety reporting.

Key Responsibilities:

• Process adverse events and associated technical complaints within safety and complaint management databases.
• Conduct duplicate searches, product coding, MedDRA coding, narrative writing, and labelling assessments.
• Receive and manage inbound and outbound calls related to adverse events, technical complaints, refunds, and replacement requests.
• Perform case triage, classification, assignment, and quality review.

Qualifications:

• Bachelor's degree required; medical or science-related discipline preferred.
• 2 years of pharmacovigilance/drug safety experience.
• Experience with:
• Adverse Event (AE) Processing
• MedDRA Coding
• Safety Case Management
• Technical Complaint Handling
• Pharmacovigilance Compliance
• Strong knowledge of medical terminology.
• Customer service experience preferred.
• Experience with audits and inspections preferred.
• Knowledge of disease states such as diabetes, obesity, haemophilia, or growth hormone disorders is a plus.
• Proficient in Microsoft Word, Excel, Outlook, and Windows applications.
• Experience with safety databases and call centre environments preferred.
• Excellent verbal and written communication skills.
• Strong analytical, organizational, and time-management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work with confidential information and collaborate across multiple functions.
• Spanish English bilingual skills are a plus.