Job Description
Work with the Pharmacovigilance (PV) team in processing adverse event and safety information, from intake to regulatory submission. The PV Associate will support both the research and the post-marketing safety functional disciplines, across all therapeutic areas, domestic and global.
Requirements - Perform intake and triage of safety information from all sources (e.g., subjects, patients, healthcare professionals, sales representatives, general public).
- Ensure that cases are accurately completed in a timely manner in accordance with appropriate SOPs (standard operating procedures), study protocols and regulatory guidelines.
- Ensure compliance with health authority regulations in drug safety data processing and reporting.
- Participate in the preparation and drafting of ad-hoc and aggregate regulatory reports (e.g., IND/DSUR/PADER/PSUR) and labeling support documents.
- Enter and track safety information in safety databases.
- Prepare regulatory safety reports, including individual case safety reports and narratives, summarizing all relevant medical information.
- Code medical terms using standardized medical dictionaries (e.g., MedDRA and WHO Drug); assist with establishing coding conventions.
- Participate in the review and reconciliation of data between safety databases and data migration activities.
- Review product complaints and assess for potential adverse events or any impact on subject safety.
- Recognize, prioritize and escalate potential safety/compliance issues.
- Conduct literature review activities related to adverse event reporting.
- Contribute to the preparation of regulatory responses, Investigator's Brochure (IBs), study protocols, case report form, safety reports, and other documents as required.
- Provide information and assistance to medical/drug information staff (internal and/or external).
- Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters (research and post-market).
- Liaise with clinical operations, medical/drug information, regulatory affairs, clinical research organizations (CRO), study sites, affiliates, and data management groups regarding safety data collection and data reconciliation as required.
- Additional responsibilities & projects as assigned.
Qualifications - BA or BS degree in Life Science, or equivalent with relevant drug safety experience.
- Drug safety and pharmacovigilance experience preferred, including experience with global drug safety databases, MedDRA, and WHO-Drug coding dictionaries.
- Knowledge of regulatory authority regulations and guidance (e.g., FDA, ICH) as well as electronic submissions (E2B).
- Experience with safety databases.
- Team player, detailed-oriented and be willing to work in a fast-paced environment with time-sensitive materials.
- Proficient in using Microsoft Office, including Excel and Word.
- Strong analytical and problem solving skills.
Strong oral and written communication & interpersonal skills.
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