Pharmacovigilance Associate Job at OPKO Health, Inc., Miami, FL

NGFlaHp3RVpYRit4TlFqc0hyc1hON2dtNkE9PQ==
  • OPKO Health, Inc.
  • Miami, FL

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.

Minimum 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.

OPKO Health is an equal opportunity employer.

Job Tags

Similar Jobs

Jobleads-US

Go-To-Market Director, Licensing & Extended Line Job at Jobleads-US

 ...landing strategic priorities with major US accounts like Target, Walmart and Amazon in a non-brick/non-toy capacity.In-depth...  ...-driven mindset that stems from multiple years of key account management experience including P&L responsibility.Proven experience in... 

Fairfield Property Management

Leasing Agent Job at Fairfield Property Management

 ...Health insurance ~ Paid time off ~ Vision insurance Job Summary Fairfield Property Management is seeking a motivated Leasing Agent with great communication skills to join our team! As the liaison between our management office and current/prospective... 

Polymaker LLC

Paid Marketing Manager Job at Polymaker LLC

Location: Houston, Texas (On-Site, Full-Time) About Polymaker Paid Marketing Manager/Specialist Job Description Polymaker is a global leader in 3D printing materials innovation. Our mission is to empower creators, engineers, and industries to unlock new possibilities...

Core Medical Group

Travel Wound Care Nurse - $2,260 per week Job at Core Medical Group

 ...Core Medical Group is seeking a travel nurse RN Wound Care for a travel nursing job in Detroit, Michigan. Job Description & Requirements ~ Specialty: Wound Care ~ Discipline: RN ~ Start Date: 06/17/2025~ Duration: 13 weeks ~40 hours per week ~ Shift:... 

Semper Valens Solutions

Physical Security Specialist Job at Semper Valens Solutions

 ...Job Description Job Description Physical Security Specialist Full time Aberdeen, MD Top Secret /SCI clearance Referral bonus: $1,000 Semper Valens Solutions is looking for a qualified and motivated Physical Security Specialist (Security Professional) -...