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OPKO Health, Inc. · 2 days ago

Pharmacovigilance Associate

United States

Full-time

Remote

New Grad, Entry Level

OPKO Health, Inc. is focused on advancing healthcare solutions, and they are seeking a Pharmacovigilance Associate to support the processing of adverse event and safety information. The role involves ensuring compliance with health authority regulations and participating in the preparation of regulatory reports while collaborating with various teams on safety data collection.

BiotechnologyHealth DiagnosticsPharmaceutical

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

Qualification

Drug safety experiencePharmacovigilance experienceRegulatory knowledgeSafety databasesMedDRA codingWHO-Drug codingMicrosoft OfficeAnalytical skillsCommunication skillsInterpersonal skills

Required

BA or BS degree in Life Science, or equivalent with relevant drug safety experience

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

Preferred

Drug safety and pharmacovigilance experience preferred, including experience with global drug safety databases, MedDRA, and WHO-Drug coding dictionaries

Company

OPKO Health, Inc.

At OPKO Health, we seek to serve unmet patient needs through our first in class products, comprehensive diagnostics laboratories, robust research and development pipeline, and unique pharmaceutical business solutions.

Founded in 2005