Product Life Group is looking for Vigilance Specialist to join our dynamic PV team.
Ability to support the QPPV Line of Business
Ability to support in PV audit and inspection
Ability to take the role of France responsible person for Pharmacovigilance. (LRPPV)
Ability to take on EUQPPV and UK QPPV responsibilities:
− Main contact and communication for health authority and the MAH.
− Revison of PhV contract/SDEA
− Monthly reconciliations with partners
− Monthly surveillance of local Health Authority websites for identification of safety related data.
− PSMF preparation, review and finalization
− Technical agreement redaction/review
Education & Experience
Life sciences degree or Healthcare professional (Pharmacist, dentist, or medical degree is a plus)
2-8 years of experience in Pharmacovigilance/drug safety
Experience in case management or medical information and literature or medical writing in English
Knowledge of the relevant European and French regulation and EU GVP
Experience as a deputy EUQPPV or working closely with the QPPV office would be an advantage
Ability to take on EU-QPPV and UK QPPV responsibilities
EU GVP and ICH/GCP understanding
Agility and analytical
Good interpersonal skills, team player and excellent communication skills
Ability to attend customer facing teams & F2F meetings
Proficiency in professional and technical Organization, initiative, anticipation and adaptability
French speaker and any other European language would be desirable