Responsibilities:

• Oversee vendors handling adverse event (AE) and product quality complaint (PQC) intake and processing.
• Ensure compliance with global regulations (FDA, ICH, EMEA, MHRA) and Client's standards.
• Monitor vendor performance on quality, compliance, and productivity metrics.
• Support audits, inspections, and training programs (including train-the-trainer and refresher courses).
• Act as a subject matter expert on AE/PQC intake and liaise with internal teams for process improvements.
• Review case documentation for accuracy and provide constructive feedback.

Qualifications:

• Bachelor’s degree in Nursing (RN/BSN), Pharmacy (BS Pharm/PharmD), or related field.
• 2–4 years of clinical healthcare experience; pharmaceutical industry or contact center experience preferred.
• Strong understanding of pharmacovigilance and regulatory guidelines (FDA, ICH, etc.).
• Excellent communication, documentation, and problem-solving skills.
• Proven ability to manage vendor relationships and deliver process improvements.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)