Responsibilities

Experienced in,
  • Handling of the team and support in MW
  • Working closely with QPPV and aware of QPPV role
  • Periodic Safety Update Report (PSUR/PBRER/PADER)
  • Addendum to Clinical Overview (ACO)
  • Development safety update report (DSUR)
  • Risk management plans (RMP)
  • Signal Detection Reports
  • Experienced in providing the responses of assessment reports from agencies
  • Ability to attend customer facing remote meetings & F2F meetings and communication
  • Analysis and assessment of benefit/risk profile of the products
  • Ability to participate to clients audits and inspections
  • Good interpersonal skills, support in utilization of the team members
  • PSMF, SDEA and PV TA review and finalization

Required Education

Bachelor or Master of Pharmacy, life science , Medical degree

Required Experience

More than 8 years of experience in PV

Technical Skills

Knowledge of the relevant EU regulations and GVP Modules

Additional Experience

  • Audits and Inspections experience would be an advantage
  • Good interpersonal skills, team player and excellent communication skills
  • Good team handling skills

Publish Date

14 September, 2023

Spontaneous Application

Director-Medical Writing 984

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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