Global Patient Safety PV Manager

Global Patient Safety PV Manager
TFS, Sweden

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Mar 16, 2021
Last Date
Apr 16, 2021
Location(s)

Job Description

Manage safety data using analytical skills, by processing all types of individual case safety reports (ICSRs) and aggregated reports and summaries of data. Develop and maintain processes required for Pharmacovigilance Systems.


Key Responsibilities

  • Contribute to receipt, tracking, monitoring and documentation of ICSRs
  • Perform data entry and quality control of ICSRs within the case-handling process
  • Contribute to exchange of ICSRs with internal and external sources, and to regulatory reporting
  • Contribute to follow-up of ICSRs
  • Support and participate in audits and inspections
  • Contribute to management of GPV Operation mailboxes

Requirements

  • University level qualification in biosciences or healthcare
  • At least 1 years’ experience post-graduation in the pharmaceutical industry
  • Thorough knowledge of regulatory Pharmacovigilance requirements, specially within the European Union and US
  • Fluent in English
  • Computer Literate
  • Able to work effectively both independently and collaboratively across the organization
  • Team player
  • Delivery focused with ability to exercise judgment, make decisions, and take action to complete assignments
  • Good attention to detail with high quality written outputs, with good organizational abilities, prioritization, and time management proficiencies.
  • Demonstrated problem solving the ability to successfully execute in an environment under time and resource pressures whilst maintaining resilience

Benefits

  • Private Health Insurance
  • Pension Plan
  • Paid Time Off
  • Work From Home
  • Training amp; Development

Job Specification

Job Rewards and Benefits

TFS

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