Team Leader Case Specialist 822

ProductLife Group is looking for a Team Leader -Case Specialist to join our dynamic team to contribute to the activities performed in the Hub:

Group 10

  • To provide specialised and dedicated pharmacovigilance support to the team specifically with the review, assessment and querying of safety reports/case reports.
  • Accountable for adherence to client internal timelines, client specific conventions, compliance, ensuring quality and supporting the wider team.
  • Ability to support/participate in the regulatory authority inspections or internal client audits.
  • Strong understanding of FDA, EMA (GVP) and other Health Authority regulations

Group 10
Education and Experience

  • Preferably with a scientific background- Pharmacist
  • 5-10 years case processing experience (clinical and post-marketing).
  • In depth knowledge of GCP
  • In depth knowledge of GVP (especially module VI)
  • ICH E2B guidelines
  • Experience processing complex cases
  • Identification of special situations and instances of off label use
  • Development of SOPs and trainings
  • PV database experience essential (Argus)

Group 10

  • Good organizational skills
  • Positive attitude
  • Willingness to learn (job related and software related)
  • Team player
  • Pro-active thinker
  • Stress resistant
  • Demonstrated skills as a mentor/trainer
  • Client communications

Team Leader Case Specialist 822