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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 272121

Drug Safety Officer

  • Pharma & Biotech
  • Asap
  • Clinical Studies, Case Processing, PV Systems
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Masters in biological and medical sciences
Language Skills
French (native), English (business fluent)
Relevant Expertise
Drug Safety, Aggregate Reports, PV Reports, Clinical Studies, Case Processing, PV Trainings, Risk Management, PV Systems, Signal Detection, Project Management, Pharma, Biotech

Key Facts

  • Is working in the area of Pharmacovigilance for over 20 years

  • He has extensive experience of whole life cycle from clinical development till post marketing

  • Tremendous knowledge when it comes to: Aggregate Reports (PSUR, DSUR, PBRER, PADER), Risk Management, Signal Detection, Project Management and different PV Systems

  • Pursues a hands-on management style combined with strong communication skills

Extract from Previous Activities

2020 – date

Pharmaceutical Company, France

Case Medical Safety and Quality Expert

  • Identify KPIs, Topics & Trends in Case Processing samples

  • Perform Data analysis

  • Discuss CAPA and participate in CAPA elaboration (ad hoc)

  • Lead/present data during Quarterly Oversight Meeting

  • Monitor CAPA implementation

  • Management of French Legal cases from the patients

2017 – 2019

Pharmaceutical Company, France

Drug Safety Officer

  • Approval and medical assessment of PV reports from both post marketing experience and clinical studies (Immunotherapy)

  • Prepare aggregate reports within the timelines to Health authorities and Ethics committees of all safety (PV) data (PBRER / PSUR / PADER / DSUR / RMP)

  • Participation in the maintenance of the quality management system

  • Drafting and Validation of the SOPs

  • Regular Signal Detection and evaluation

  • Weekly Literature screening

  • PV training to different affiliates around the world

  • Participation in auditing and CAPA

  • Participation in CCDS preparation, Provide safety data for CTD submission

  • Review and drafting of Pharmacovigilance sections of clinical trial documents (study protocols, investigator's brochure, clinical study reports) in collaboration with different departments concerned

2015 – 2017

Pharmaceutical Company, France

Senior Pharmacovigilance Specialist

  • Staff management (PV Manager, Budget and Training)

  • Deputy for EEA QPPV and EVRP for different customers

  • To Know and be able to interpret/apply relevant technical/scientific guidelines

  • Provide relevant knowledge in the specific technical/scientific area to the other team members and advise Clients on technical questions

  • Participate in the writing of deliverables and especially the sections in relation to this specific technical/scientific area

  • Participate in the in-process and final review of deliverable