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Director, Vaccine Pharmacovigilance Benefit-Risk Physician

Zurich, Switzerland

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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Success

What makes a successful member of our team?

We take action and make decisions by focusing on our four priorities in this order:

  • 1

    Putting the patient
    at the center

  • 2

    Building trust
    with society

  • 3

    Reinforcing our
    reputation

  • 4

    Developing the
    business

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Life at Takeda

  • Our People

    Our people

    To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.

  • Anders Tellefsen

    Procurement Lead, Northern Europe

    Anders Tellefsen
    “Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
  • Yves Leurquin

    Regional Head, Europe, Vaccines

    Susan Tillman
    “Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”

Opportunity

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

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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

DIRECTOR, VACCINE PHARMACOVIGILANCE BENEFIT-RISK PHYSICIAN

OBJECTIVES

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

ACCOUNTABILITIES: 

  • 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.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • 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.

*LI-TC2-EUR

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0010979

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