Job Description

Join to apply for the Pharmacovigilance Associate role at OPKO Health, Inc. Join to apply for the Pharmacovigilance Associate role at OPKO Health, Inc. This range is provided by OPKO Health, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $28.85/hr - $35.00/hr About the Role The PV Associate will support both the research and the post-marketing safety functional disciplines, across all therapeutic areas, domestic and global. 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. Required Skills Drug safety and pharmacovigilance experience preferred. Knowledge of regulatory authority regulations and guidance. Experience with safety databases. Proficient in using Microsoft Office. Strong analytical and problem solving skills. Preferred Skills Experience with global drug safety databases. Experience with MedDRA and WHO-Drug coding dictionaries. OPKO Health is an equal opportunity employer. Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Administrative Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at OPKO Health, Inc. by 2x Inferred from the description for this job Medical insurance 401(k) Get notified about new Drug Safety Associate jobs in Miami, FL . BC_Oncology-Clinical Research Associate/Recruitment Specialist Senior Clinical Research Associate - East Coast - Florida - Spanish speaking Miami, FL $49,393.77-$49,393.77 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr OPKO Health, Inc.

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