Vaccines Pharmacovigilance Scientist (TKPHJP00001394) (m/f)

Zurich  ‐ Onsite
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Description


  • Takeda is a patient-oriented and innovative global pharmaceutical company, that is based on a 235 years old history and that always seeks to improve people's lives by researching, developing and bringing to market new and better medicines that help to address the nation's most pressing healthcare needs

Vaccines Pharmacovigilance Scientist (TKPHJP) (m/f)

Reference: -en
Start: asap
Duration: 12 MM++

Main tasks:
  • PV support for developmental programs, including both early and late stage development as required
  • Supports Vaccines Safety lead for assigned products, e.g. by performing the following activities
  • Compilation, analysis and Review of safety data and safety signal management for designated compound(s)
  • Prepares/reviews PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
  • Prepares/reviews Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports (e.g., Health Hazard Evaluations)
  • Reviews safety data and participates in dose escalation/continuation of vaccination decisions
  • Contributes to Safety Monitoring Plan/Risk Management Plan
  • Performs data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
  • Contributes to the set-up of safety procedures and development of safety exchange agreements for co-development projects


Main qualifications
  • Life science degree (BSc, MSc)
  • Vaccines and/or biotechnology industry experience preferred
  • Extensive experience in clinical trials and postmarketing pharmacovigilance
  • In-depth knowledge of the pharmaceutical and/or biotechnology industry in Pharmacovigilance functioning as a Pharmacovigilance specialist
  • Strong investigational event and aggregate assessment/review/documentation skills
  • Working knowledge of US/EU/APAC regulations and ICH guidelines
  • Experience in communicating with the FDA, EMA, and other global health authorities
  • Sound working knowledge of MedDRA coding
  • Understanding of pharmacovigilance-related information systems
  • Expert in Aggregate Report preparation and review
  • Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired
  • Leadership/managerial experience preferred


Main advantages:
  • Work experience in a global pharmaceutical environment
  • Gain experiences with vaccines (rare skill)
  • Takeda seeks to improve people's lives by researching, developing and bringing to market new and better medicines that help to address the nation's most pressing healthcare needs



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Start date
ASAP
Duration
12 MM++
(extension possible)
From
Hays AG
Published at
15.05.2018
Contact person:
Kerstin Werner
Project ID:
1554902
Contract type
Freelance
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