We are looking for a motivated and engaged new team member to support our Pharmacovigilance team based in Munich:

(Senior) Professional - Pharmacovigilance / Drug Safety Officer (m/w/d) Clinical Research
Kantar Munich​


Kantar’s Health Division is a leading global healthcare consulting company and trusted advisor to many of the world’s leading pharmaceutical, biotech, and medical device and diagnostic companies. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Kantar’s CRO business unit has almost 40 years of experience in the field of Clinical trials, Late Phase studies, non-interventional studies and epidemiological research.


YOUR TASKS
 
  • Case processing and follow up on (serious) adverse events occurring in non-interventional studies and clinical trials
  • Triage for reported adverse events
  • Creation and review of project specific Safety Management Plans and other project specific Safety documents
  • Screening of CRF data for adverse events
  • Preparation of periodic Safety status reports
  • SUSAR reporting within clinical trials
  • Support of creation of periodic safety reports (PSUR, DSUR)
  • Archiving and maintenance of Safety related documentation including maintenance of the Safety database
  • Quality control and pro-active improvement of safety procedures
  • Coding of adverse events with MedDRA 
 
 
YOUR QUALIFICATIONS
 
  • Graduate scientist in pharmacy, life sciences, medicine or vocational qualification
  • Minimum 2 years of practical experience in Pharmacovigilance, preferably within a CRO environment
  • Profound knowledge in local German and international regulations, especially in Drug Laws, GCP and GVP
  • Practical experience in Medical Writing, especially in the preparation of PSURs, DSUR and study reports is a plus
  • Experience using EVWeb desirable
  • Profound knowledge in MedDRA
  • Knowledge in the safety of medical devices is an advantage
  • Excellent communication skills in (spoken and written) English and German
  • Very high accuracy, well-structured and organized, high ability to understand complex facts
  • Ability to work independently but also work in a team
  • Service and client-oriented, focus on work with high quality
  • High resilience and assertiveness
  • Very good skills in MS Office

WHAT WE OFFER
 
  • We support your work-life balance with flexible working hours
  • We give you room to breathe through our extraordinary number of vacation days (30 + 5)
  • We support your wish for a sabbatical
  • We value your work, e.g. by annual salary adjustments
  • We safeguard your well-being, for instance with an accident insurance and we offer a subsidized company pension scheme
  • We socialize in our cantine and coffee bar


We are looking forward to your application including your salary expectation and notice period. Please be aware that due to data privacy, we are only able to accept your application via our online form.



HR CONTACT
Ms. Zuzana Markuskova
Tel. +39 348 016 9197
www.kantardeutschland.de


Kantar aims for diversity and equal opportunities.