General Electric Canada Careers 2021 | Apply For Drug Safety Specialist Jobs In Canada

General Electric Canada Careers 2021 | Apply For Drug Safety Specialist Jobs In Canada | General Electric Canada Careers 2021 | Latest Government Jobs In Canada, Latest Government Jobs in General Electric Canada Jobs. The Latest Information On General Electric Canada Jobs In Canada. Upcoming Government of Ontario Jobs In Canada General Electric Canada Careers. General Electric Canada Jobs For All Latest Notification Visit Official Web Site.

Canada Jobs Seekers who are looking for General Electric Canada Jobs in Canada can check here Canada Government Jobs in General Electric Canada. General Electric Canada jobs opportunity is available for Drug Safety Specialist Jobs In Canada.

General Electric Canada Careers | Jobs For Drug Safety Specialist Jobs in Canada

General Electric Canada Job Accounting Jobs in Canada:– General Electric Canada Jobs portal open for Drug Safety Specialist jobs vacancy in their Canada Branch. Currently General Electric Canada Job Drug Safety Specialist Jobs in Canada available now. Candidates who are searching for This Jobs in Canada with relevant experience can apply for General Electric Canada Careers Employment. Salary will be given to the candidate after selection of $ 62,288.00 Per Year (Not Conform).

General Electric Canada Careers Briefed Table

Department & AgencyGeneral Electric Canada
Job Profile –  Vacant PositionDrug Safety Specialist
Job StatusFull Time
Salary$ 62,288.00 Per Year (Not Conform)
Job LocationMississauga, Ontario
Job Type
Jobs In Canada

Overview / Job Description

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

Final Selection for General Electric Canada Careers Jobs In Canada

Candidates who have the required eligibility Drug Safety Specialist position can apply through the General Electric Canada careers page link provides in the below section. You can check on this page all upcoming General Electric Canada Jobs in Canada and other Accounting jobs in Canada Government Jobs.

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