Pharmacovigilance Specialist II
Takeda Pharmaceuticals - Deerfield, IL

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OBJECTIVES:
  • Provide pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians

  • Represent pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams.

  • Lead signal detection/safety monitoring activities for pharmacovigilance operations.

ACCOUNTABILITIES:
  • Ability to perform case report QC, review, follow-up and reportability assessments.

  • Liaise with other relevant functional areas within TGRD, TPC and external parties to provide input on safety data collection, analyses, and risk management.

  • Represent pharmacovigilance department in cross-functional teams or committees and external environments that have global study or program impact.

  • In depth knowledge and understanding of designated products/studies.

  • Participate as Pharmacovigilance expert in the Global Safety Teams for designated products.

  • Work closely with Global Safety Lead on all aspects of signal detection/safety review activities.

  • Perform advanced searches in the safety database to retrieve requested safety data.

  • Active participation in internal and cross functional Task Forces

  • Project support activities for designated developmental products include:


    • Master working knowledge of regional protocols to effectively respond to safety issues.

    • Provide investigator and monitor training on safety procedures

    • Compile and write IND update/ACSR documents

    • Assist in set up of safety procedures and contribute to development of safety exchange agreements for co-development projects

    • Develop department templates for clinical and post-marketing projects

    • Compile, write and review monthly safety reports

    • Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents

    • Assist with writing and maintenance of the Safety Monitoring Plan

    • Assist with set-up and running of DSMBs

  • Project support activities for designated marketed products


    • Write, compile, and review of PSURs

    • Review of monthly safety reports

    • Assist in set up of safety procedures and contribute to development of safety exchange agreements for co-marketing projects

    • Develop department templates for post-marketing projects

    • Assist with writing and maintenance of the Risk Management Plan

  • US only activities include:


    • Creation of FDA periodic reports

    • Training of marketing and sales force in safety related topics

    • Review and provide input into documentation related to investigator sponsored studies

    • Liaison for internal commercial operations team (Commercial Product Quality, Medical Information, Medical Affairs) and external call center providers.

    • Review and provide input into documentation related to marketing studies (e.g., Registries)

    • Liaison and training of call-centre providers.

  • Identify, plan, and execute improvement of departmental processes.

  • Any other tasks assigned by manager to assist in departmental activities.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
  • Registered Nurse or Bachelors degree required; scientific/medical field preferred
  • Minimum 4 years healthcare, clinical or pharmacovigilance related experience including a minimum of 2 years in clinical monitoring, safety or Pharmacovigilance.
  • Excellent databases and coding skills including ability to perform advanced searches
  • In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
  • Critical thinking and decision making skills
  • Ability to review, analyze, interpret and present complex data to a high standard
  • Understanding of Takeda business needs with global business perspective and professional attitude.
  • Good level of computer literacy with Microsoft applications
  • Excellent organization skills and ability to prioritize
  • Excellent written and oral communication skills including ability to present to large internal/external groups.

TRAVEL REQUIREMENTS:

Estimated 5-10 times per year including possible international travel.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

*LI-KB1

Schedule
Regular Full-time

Takeda Pharmaceuticals - 17 months ago - save job - block
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