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Sr. Assoc., Pharmacovigilance Operations
Posted: 06/04/2026
Employment Type:
Contract
Job Category: Pharmacovigilance (PV)/Drug Safety
Job Number: 5074
Job Description
Our client is seeking a highly organized and detail-oriented Sr. Associate, Pharmacovigilance Operations to support the safety surveillance process for pharmaceutical products. This role involves managing case follow-up activities with patients and healthcare professionals, ensuring vendor compliance, overseeing case quality metrics, and maintaining accurate safety reporting to regulatory authorities. The ideal candidate will play a key role in maintaining compliance with global regulatory requirements, supporting audit activities, and fostering strong vendor relationships, all while contributing to patient safety and product integrity.
Key Responsibilities:
- Perform thorough review and follow-up of individual case safety reports (ICSRs) with patients and healthcare professionals.
- Support the development, delivery, and maintenance of training materials related to pharmacovigilance activities.
- Ensure all safety reporting activities are completed in accordance with established timelines, quality standards, and regulatory criteria.
- Manage case processing activities, including case review, data entry, and medical coding, using safety databases (preferably Lifesphere Multivigilance by ArisGlobal).
- Interface effectively with local office staff, clinical research organizations (CROs), and business partners to resolve case processing issues.
- Support E2B submissions, including nullification and redistribution, to ensure accurate and compliant data transfer.
- Serve as the primary point of contact for audit activities related to case processing and safety reporting.
- Manage vendor relationships, ensuring compliance with contractual safety agreements and quality standards.
- Oversee and analyze trend reports to identify areas for quality improvement.
- Act as the FDA point of contact for ICSR reporting, including submission of safety reports to the FDA, EMA, and other partners.
Qualifications:
- Master’s degree or Bachelor’s degree with 2+ years of pharmacovigilance experience; or Associate’s degree with at least 6 years of relevant experience.
- Solid understanding of global regulatory requirements for pharmacovigilance.
- Experience with clinical development processes and case processing.
- Attention to detail and accuracy in data management.
- Proficiency in safety database systems, preferably Lifesphere Multivigilance by ArisGlobal.
- Knowledge of medical coding and medical terminology.
- Strong written and verbal communication skills in English.
- Competent in Microsoft Office applications.
- Ability to work independently in a remote setting and collaborate effectively across teams.
Work Location: Remote - United States