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Director, Vaccines Pharmacovigilance Medical Safety

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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    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.”

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Director, Vaccines Pharmacovigilance Medical Safety

Apply Now
Job ID R0007575 Date posted 03/11/2019 Location Zurich, Canton of Zurich

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Job Description

Director, Vaccines Pharmacovigilance Medical Safety

OBJECTIVES:

Provide medical oversight on Adverse Event processing, including medical review and signal management to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and global and local regulatory requirements. This will include pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to compounds in development and marketed products.

ACCOUNTABILITIES: 

  • Responsible for medical oversight on the reporting and processing of individual case safety reports and other safety relevant information in association with assigned products, including medical review of SAEs and nonserious AEs occurring during clinical development and postmarketing surveillance of assigned products as well as input for medical coding of events according to standard MedDRA terminology and data cleaning.
  • Provide oversight and guidance to Medical reviewer from outsorced vendor’s or contractors to ensure consistent high-quality reports.
  • Responsible for early safety signal detection activities (identified through medical ICSR review) for Vaccines Business Unit (VBU) portfolio of investigational and marketed products; support Vaccine Safety leads for medically-reasonable evaluations of safety signals, including the preparation of safety signal evaluation reports; make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals
  • Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
  • Responsible for early signal detection & medical surveillance process improvements and updates, including new means of effective presentation of early phase clinical study status reports with regard to safety findings.
  • Perform activities required to serve as VBU PV representative as outlined in applicable Takeda quality managem system documents (e.g. Procedures, Job Aids). This includes
    • 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, PV audits & inspections as applicable.

Education:  Medical Degree (MD)

Skills:

  • Medical Degree (MD) required
  • Vaccines and/or biotechnology industry experience preferred
  • Minimum 8 years of experience in clinical trials and postmarketing pharmacovigilance
  • Minimum 5 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance functioning as a senior Pharmacovigilance Physician, including profound experience in medical assessment, signal detection and management as well as aggregate safety reports
  • Strong investigational event and aggregate assessment/review/documentation skills.
  • Strong working knowledge of US/EU/APAC regulations and ICH guidelines.
  • Strong experience in risk management plan preparation and review, including European Union Risk Management Plans (EU - RMPs) and US REMS.
  • Experience in communicating with the FDA, EMA, and other global health authorities.
  • Sound working knowledge of MedDRA coding.
  • Good understanding of pharmacovigilance-related information systems.
  • Vaccines and/or biotechnology industry experience preferred

Desired Characteristics:

  • Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.
  • High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach".
  • Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired.
  • Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.
  • Demonstrated experience in effectively working in matrix organisations, systems, and processes; proven ability to identify, select and manage a variety of external resources.

TRAVEL REQUIREMENTS:

  • Requires approximately 10% - 20% travel, including overnight and international travel to other Takeda sites and other required travel.

*LI-TC2-EUR

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0007575

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