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Director, Vaccine Pharmacovigilance Benefit-Risk Physician

Zurich, Switzerland


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Director, Vaccine Pharmacovigilance Benefit-Risk Physician

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Job ID R0010979 Date posted 08/21/2019 Location Zurich, Switzerland

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Job Description



Responsible for providing support to Takeda’s Vaccine Pharmacovigilance in the monitoring of the safety profile of assigned products within agreed time frames and to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and global and local regulatory requirements.

  • Support developmental programs, including both early and late stage development as required.
  • Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s). 
  • Supporting Global Head Vaccines PV, Functional management of contractors and/or junior staff supporting the assigned product


  • Perform activities required to serve as Vaccine Safety Lead as outlined Takeda quality management system documents (e.g. applicable Procedures, Job Aids). This includes:
  • Review and oversight of safety data and safety signal management,
  • Review and/or sign off of protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
  • Preparation, review and and sign off of Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
  • Interactions with external experts and regulatory agencies and partner/co-development companies
  • Review of safety data and participate in dose escalation/continuation of vaccination decisions
  • Authorship / sign off of Safety Monitoring Plan
  • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
  • Direct the set-up of safety procedures and development of safety exchange agreements for co-development projects
  • Perform activities required to serve as VBU PV representative as outlined in applicable Takeda quality management system documents (e.g. Procedures, Job Aids). This includes:
  • Reviews and performs clinical evaluation of individual case safety reports of SAEs and non-serious AEs occurring in association with assigned products, including input for medical coding of events according to standard MedDRA terminology, as well as data cleaning.
  • Reviews clinical protocols and other clinical development documents to ensure adequacy of safety sections, assists in the preparation of other safety documents, as required (e.g., the Investigator's Brochure (IB), CCSI).
  • Responsible for the  development and maintenance of the Reference Safety Information for assigned products (e.g., Company Core Safety Information DCSI / CCSI, the respective information of the Core Data Sheet and Investigator's Brochure).
  • Supports the preparation of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
  • Ensures integration or Benefit Risk Management framework / tools / expertise in global development and commercialization process
  • Performs signal detection analyses and evaluation of potential signals, incl. respective literature search.
  • Prepares, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators.
  • Provides input into responses to inquiries from internal sources, health care professionals, and other external sources.
  • Provides support as required for licensing activities, regulatory authority inspections, company audits, and for project product recall activities.
  • Performs pharmacovigilance training and mentoring of internal and cross-functional team members.
  • Participates as a safety expert in Clinical Trial Teams, Clinical Development Teams, DMC meetings, Investigator meetings, as applicable.


  • Minimum of 7 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organisation. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required and ideally  experience in filing vaccines products.
  • Vaccines and/or biotechnology industry experience preferred
  • Strong investigational event and aggregate assessment/review/documentation skills.
  • Extensive working knowledge of US/EU/APAC regulations and ICH guidelines.
  • Proven experience in communicating with the FDA, EMA, and other global health authorities.
  • Sound working knowledge of MedDRA coding.
  • Excellent  understanding of pharmacovigilance-related information systems.
  • Expert in Aggregate Report preparation and review.



Zurich, Switzerland

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0010979

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