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

NFVRdm1pSWFRVkpWdzBXQVNXVGtFTlp5aVE9PQ==
  • 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

Workforce Solutions Cameron

Regional Convener Coordinator Job at Workforce Solutions Cameron

 ...Workforce Initiative (Texas Education Agency, Texas Higher Education Coordinating Board and Texas Workforce Commission) by linking workforce,...  ...audiences. Ability to manage time efficiently and meet deadlines. Able to travel locally, statewide, and out of state.... 

Triple-S Steel Holdings, Inc.

Payroll Specialist Job at Triple-S Steel Holdings, Inc.

 ...handle frequent interruptions and shifting priorities. ~ Has experience in the following systems: ADP Workforce Now (required), Kronos Workforce Dimensions (preferred), iCIMS (preferred). ~ Experience with Microsoft tools, specifically Excel (required). ~ Bilingual... 

LHH

Mechanical Engineer Job at LHH

 ...Job Summary The Mechanical Engineer is responsible for providing hands-on technical expertise...  ...mechanical equipment, including pumps, conveyors, refiners, pressure vessels, boilers,...  ...capital projects, including equipment installations, modifications, and plant expansions.... 

Vectour Group

Employee CDL Driver PT - Shuttle Operations Job at Vectour Group

 ...Job Description: EMPLOYEE SHUTTLE DRIVER (HJAIA) About Vectour Group: Vectour Group (Vectour) is a leading transportation management...  ...a clean driving record, and the willingness to work nights and weekends. Prior shuttle bus driving experience is a plus. Duties &... 

Intermodal Services Inc

CDL A Truck Driver Job at Intermodal Services Inc

 ...Company Description Intermodal Services Inc is a dry bulk trucking company based out of Belvidere, Illinois Role Description This is a full-time on-site role for a CDL A Truck Driver located in Belvidere, IL. The Truck Driver will be responsible for transporting...