Pharmacovigilance Case Safety Expert

Anova Enterprises, Inc.; Schaumburg (IL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

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Job summary

Anova Enterprises, Inc. is seeking a PV Safety Specialist to manage safety reporting across clinical trials and related programs. The role emphasizes accurate ICSR handling, case-level assessments, and collaboration with sponsors and sites to maintain compliance.

The position focuses on timely, high-quality pharmacovigilance activities, including preparation of medical narratives and regulatory submissions in line with SOPs and regulatory requirements.

Qualifications

• Experience in pharmacovigilance and handling Individual Case Safety Reports (ICSRs).
• Ability to assess seriousness, expectedness, reportability, and completeness of safety information.
• Experience ensuring expedited safety reporting to regulators within required timelines.

Responsibilities

• Manage receipt, processing, tracking, and documentation of IC/SRs.
• Perform formal case-level assessments of adverse events.
• Prepare accurate medical narratives and follow-up queries as needed.
• Ensure timely regulatory submissions for expedited reports.

Job description

Anova Enterprises, Inc. is seeking a PV Safety Specialist to manage safety reporting across clinical trials and related programs. The role emphasizes accurate ICSR handling, case-level assessments, and collaboration with sponsors and sites to maintain compliance.

The position focuses on timely, high-quality pharmacovigilance activities, including preparation of medical narratives and regulatory submissions in line with SOPs and regulatory requirements.