Job Description

About the Role - 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.

Responsibilities

• 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.

Equal Opportunity Statement - OPKO Health is an equal opportunity employer.

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