Vigilance Specialist 506

Vigilance Coordinator 463

ProductLife Group is looking for a Vigilance Specialist to join our dynamic teams as soon as possible and contribute to improve patient’s life.

About us

will be involved in QPPV role
writing of PV documents (PSMF, SDEA, PV SOPs,…) and PV training
will be facing the customer
deputy or working closely with the QPPV office would be an advantage
Audit and Inspection Participation experience
Check that all files are properly handled as the day progresses and ensure that the workload is reorganized as necessary
Ensure that all necessary information is disseminated to the relevant staff to ensure that the BU’s activities are handled correctly and within the required timeframe
Acts as a facilitator for the activity(ies) of the LoB he/she belongs to

Ability to take on EU QPPV role & deputy roles
Decision-making and alert ability
Rigor, analysis and method
Proficiency in professional and technical Organization, initiative, anticipation and adaptability
Good interpersonal skills, team player and excellent communication skills
Ability to attend customer facing teams & F2F meetings
Ability to participate to clients audits and inspections

3-7 years of experience as a drug safety or Pharmacovigilance assimilated
Experience in case management (from collection to submission), RMP, SDEA, PSUR and Signal
Experience in Eudravigilance
Knowledge of the relevant EU regulations and GVP
Audit and Inspection Participation experience would be an advantage
Experience as a deputy or working closely with the QPPV office would be an advantage