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General Electric Drug Safety Specialist in Mississauga, Ontario

Job Description Summary

Responsible for all activities related to the Global Drug Safety and Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. This individual will utilize clinical/pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives. In addition, S/he will oversee specific PV outsourced clinical trial activities and ensure that they produce a quality product and meet regulatory reporting requirements.

Job Description

Role Summary/Purpose

Responsible for all activities related to the Global Drug Safety and Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. This individual will utilize clinical/pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives. In addition, S/he will oversee specific PV outsourced clinical trial activities and ensure that they produce a quality product and meet regulatory reporting requirements.

Essential Responsibilities

  • Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature

  • Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines

  • Perform data entry and quality review of adverse event reports into the global adverse event database, including accurate coding of MedDRA terms and preparation of case narratives

  • Identify missing or discrepant information and perform active case follow-up via verbal or written contact

  • Prepare expedited reports for submission to regulatory authorities and ethics committee

  • Develops, participates and ensures the periodic internal safety review meetings/process

  • Contributes to the development, management and generation of SOPs for pharmacovigilance and drug safety monitoring. Evaluates and identifies areas that may require improvement or clarification and drafts procedural changes and adaptations as needed. Develops and implements internal pharmacovigilance guidelines, processes

  • Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., regulatory affairs, medical affairs, clinical development teams, CROs, etc) on issues related to pharmacovigilance

  • Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed

  • Support preparation of safety management plans (SMP) and interacts with PV vendors and Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and the prescriber community

  • Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed

  • Serve as pharmacovigilance resource during inspections and audits

Qualifications/Requirements

  • BS in a scientific area or healthcare and a minimum of 5 years of experience in drug safety/pharmacovigilance in the pharmaceutical/biotechnology industry; or equivalent.

  • Strong knowledge in FDA, EU, ICH Pharmacovigilance guidelines, initiatives and regulations governing both clinical and postmarketing safety.

  • Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and SUSAR/ICSR reporting

  • Experience with drug development and Phase I-III studies process and post marketing processes and regulations and knowledge and experience in the regulatory requirements for clinical trial documents and reporting is preferred

  • Serve as pharmacovigilance resource during inspections and audits

  • Solid communication, writing, and interpersonal skills with the ability to communicate technical information effectively verbally and in writing

  • Ability to work collaboratively and independently

  • Strong planning and organizational skills; detail-oriented

  • Understanding of Microsoft office applications, specifically Excel and Word

  • Experience with Argus preferred

Additional Information

Relocation Assistance Provided: No

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