Product Life Group is looking for Vigilance Specialist to join our dynamic team in Germany.

Responsibilities

  • Ability to take QPPV
  • To support the QPPV
  • Ability to support in PV audit/inspection
  • Ability to take on GPO (graduated plan officer) or local PV person responsibilities :
    − Main contact and communication for health authority and the MAH.
    − Nomination of the details with the local health authority
    − Revison of PhV contracts
    − Monthly reconciliations with partners
    − Weekly or monthly (depending on the frequency of publication)surveillance of local journals
    − Monthly surveillance of local Health Authority website for identification of safety related data.

Required Education

Life sciences degree (vigilance, Pharmacist or medical degree is a plus)

Required Experience

2-15 years of experience in Pharmacovigilance/drug safety

Required Languages

German speaker

any other European language would be desirable.

Required Technical Skills

  • Ability to take on GPO responsibilities (Stufenplanbeauftragter)
  • EU GVP and ICH/GCP understanding
  • Agility and analytical
  • 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

Additional Experience/Skills

  • 2-6 years of experience as a drug safety or Pharmacovigilance department/industry
  • Experience in case management or medical information and literature or medical writing in German or English
  • Knowledge of the relevant German regulation and EU GVP
  • Experience as a deputy GPO or (Stufenplanbeauftragter)
    or working closely with the QPPV office would be an advantage

Vigilance Specialist 963