Posted Sep 22, 2021
TFS is currently recruiting for a Senior PV-Associate to a client based in Uppsala, Sweden.
JOB DESCRIPTION / ARBETSBESKRIVNING
As the Senior PV Associate Analytics & Reporting, within the Corporate PV Department,
you will manage regular safety monitoring activities and compilation of periodic
aggregate safety reports as part of our post-market surveillance activities. You will also be
responsible for maintaining product Risk Management documentation and preparing
different safety-related reports for regulatory submissions. You will be part of crossfunctional
teams within the company to provide PV support as assigned.
JOB RESPONSIBILITIES / DITT UPPDRAG
Your main tasks:
Ensures regular and ad hoc safety data trending, signal detection and
Contributes to the regular post-market surveillance review meetings.
Coordinates and compiles the post-market surveillance plans and periodic
safety update reports (PSURs) and other aggregate safety reports
Contributes to relevant documentation for regulatory submissions for product
registration, design changes and renewals, etc.
Maintains and coordinates compilation of product Risk Management
Contributes to safety sections in the product Clinical Evaluation reports and
Post-Market Clinical Follow-up reports
Prepares responses to Competent Authorities or Notified Body for questions
related to product safety
Updates safety sections of product labelling, including the Instructions for Use
or other reference safety information and patient brochures
Supports study design discussions and compilation of safety sections of
protocols, study reports, investigator brochures, development safety update
reports (DSURs) and other applicable documentation for studies
MINIMUM REQUIREMENTS/ ÄR DU DEN VI SÖKER?
University Degree in Pharmacy or Life Sciences, ideally PhD
Fluency in English, Swedish preferable
Minimum 5 years of experience within pharmacovigilance/medical devices
vigilance in the pharmaceutical/medical devices industry
Solid knowledge of risk management and signal detection standards and
Expertise in the medical device/pharmaceutical regulations in Europe and US
Analytical skills with a capacity to interpret and compile large amounts of data
and to read and understand regulations
Excellent organization skills and the ability to plan work so that it is efficient
Independency and ability to take decisions to deliver results
Experience in collaborating with cross-functional teams in an international
Flexibility and ability to adapt in a fast-changing business environment
Positive and open-minded attitudeApply for this job