QPPV (Home Based)

Pharma Point on behalf of an established and innovative pharma consulting services organization is looking for a
QPPV (Home Based)
The function is responsible for leading and managing all activities related to PV for a cluster of pharmaceutical and medical devices clients.
Main Responsabilities:
•            ACT as EU QPPV, Deputy QPPV or Local contact
•            Establishing and maintaining/managing the pharmaceutical company's pharmacovigilance system
•            Having an overview of the safety profiles and any emerging safety concerns for the company's drugs
•            Acting as a single contact point for the Health Authorities on a 24-hour basis
•            Write and Maintenance of PSMF;
•            Perform/Approve/review: PSMF, PSUR, DSUR, RMP; ACO, Signal Detection
•            Review: ICSR processing;
•            Creation, review and revision of PV SOPs in collaboration with QA dept; 
•            Evaluate the performance of PV system in collaboration with QA dept;
•            Perform PV local assessment visit;
•            Perform training;
•            Planning of audit, and training in collaboration with QA dept
•            Prepare, Review and approval of Pharmacovigilance Agreements;
•            Coordinate activities of DSO and DSA;
•            Reconciliation Activities;
•            Preparation/management/reviewer/Approval CAPA Plan in collaboration with QA dept
•            Preparation/management/reviewer/Approval of PHV questionnaire for PHV topics
•            Support QA Department on management of PHV Quality System
•            What above also for PHV in clinical studies
•            Management of PHV inspection from Competent authority
•            Management of audit from clients of third parties
Requirements:
  • B.S./M.S. in Pharmaceutical Chemistry or other Physical Sciences
  • a minimum of 4 years of experience as QPPV in pharmaceutical industries
  • Knowledge of EU PV  regulations
  • Excellent English  written and oral communication skills
Business unit
Farmacoviglianza
Sedi
Italia

CONTATTI

Pharma Point Srl - Foro Buonaparte, 48 - 20121 Milano, Italia

Email: info@pharmapoint.it - Tel. +39 02-89013167

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