Associate Pharmacovigilance Operations

  • Posted 5 hours ago | Updated 5 hours ago

Overview

Remote
Depends on Experience
Contract - W2
Contract - 6 Month(s)

Skills

Pharmacovigilance

Job Details

Job Title: Safety Surveillance Specialist Pharmacovigilance

Job Summary:
We are seeking a detail-oriented and organized Pharmacovigilance Specialist to support safety surveillance processes by managing follow-up activities for individual case safety reports (ICSRs). The role includes vendor oversight, case quality assurance, regulatory submissions, and serving as a key contact for audits and business partner communications.

Key Responsibilities:

  • Perform case reviews and ensure timely reporting of ICSRs to global regulatory authorities (FDA, EMA) and partners.

  • Oversee quality of US ICSRs, monitor trends, and address issues with vendors.

  • Act as the point of contact for case-related queries, business partners, audits, and regulatory communication.

  • Provide E2B support (nullification, redistribution) and coordinate follow-up testing (non-LAO).

  • Ensure compliance with all reporting timelines and processes.

  • Contribute to training materials and support convention-related training.

Required Skills & Qualifications:

  • Bachelor s degree with 2+ years of relevant experience OR Associate degree with 6+ years of experience.

  • Strong communication and organizational skills.

  • Experience in pharmacovigilance and ICSR case processing.

  • Familiarity with Argus safety database and global PV regulations.

  • Proficient in medical coding and MS Office applications.

  • Excellent phone and written communication skills in English.

Top 3 Must-Have Skills:

  • Strong verbal and written communication

  • Prior pharmacovigilance experience or exposure

  • Highly organized and detail-oriented

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