Responsibilities

  • Experienced in preparation and review of,
  • ➢ Periodic Safety Update Report (PSUR/PBRER)
  • ➢ 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

Profile

  • Master of Pharmacy / Pharmacist / Physician
  • 4 - 12 years of aggregate report experience
  • Knowledge of the relevant EU regulations and GVP Modules
  • Audits and Inspections experience would be an advantage
  • Agility and analytical
  • Proficiency in professional and technical Organization, initiative, anticipation and adaptability
  • Good interpersonal skills, team player and excellent communication skills
  • Good team management skills

Publish Date

18 January, 2023

Spontaneous Application

Senior Medical Writer 765

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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