Medical Writer LRPPV 671

ProductLife Group is looking to strengthen its PV Team. We are looking to fill the position of a Medical Writer LRPPV.

Group 10
Responsibilities:

  • Experience in preparation and review of Signal Detection Reports, Periodic Safety Update Report (PSUR/PBRER), Development safety update report (DSUR), Risk management plans (RMP),
  • An experience in the redaction of “Dossier de Transparence” and “Autorisation d’Accès Précoce” would be really appreciated.
  • Ability to perform LRPPV role and deputy (Local PV person in France)
  • Good interpersonal skills, team player and excellent communication skills
  • Ability to attend customer facing remote meetings & F2F meetings
  • Ability to participate to clients audits and inspections

Group 12
Ideal profile

  • Physician / pharmacist, specialist in PV safety reports
  • Minimum of 4 – 10 years of experience years.
  • Knowledge of the relevant EU regulations and local French regulation
  • Experience in case management (from collection to submission)
  • Audit and Inspection Participation experience would be an advantage
  • Experience as a deputy or working closely with the QPPV office would be an advantage
  • Good interpersonal skills, team player and excellent communication skills
  • Good team handling skills
  • Practical and theoretical knowledge of Medical writing
  • Ability to take on LRPPV (Local PV person in France) role & deputy roles

Medical Writer LRPPV 671