Posted to MedZilla HealthCare on 10/20/2018


Takeda Pharmaceuticals

US-MA, Sr Mgr, Clinical Trial Pharmacovigilance Operations Oversight R0004683-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr Mgr Clinical Trial PV Operations Oversightin our Cambridge office.

OBJECTIVE:

Senior Manager, Clinical Trial PV Operations Oversight is responsible for overall leadership to support global principles and standard practices for operational activities for clinical trials.

Provides global functional expertise and strategic support to oversee and direct Clinical Global Pharmacovigilance operations activities including set up and conduct of clinical studies from a safety perspective, CRO training, agreements and management. Partners with key stakeholders within and outside PV to ensure continuous harmonised operations of global Pharmacovigilance activities and to maintain highest standards for integrated functioning.

ACCOUNTABILITIES:

  • Responsible for global oversight for Regulatory compliance and management of safety CRO activities for assigned region/therapeutic area
  • Provides strategic oversight of study management plans for PV operations ensuring PV Clinical and Product Support goals align with goals of the entire organization
  • Support review and reconciliation of invoices and help track Purchase Order spending
  • Support Resource forecasting based on historical data and future activities
  • Contribute to the development and maintenance of business continuity plans
  • PV operations ensuring PV Clinical goals align with goals of the entire organization
  • Participate in the conduct of Audits and Inspections related to PV Operations
  • Manages vendor operational meetings to ensure compliance with PV operational responsibilities
  • Oversight for investigator and CRO training
  • Maintain knowledge of PV Regulations and global industry practices for PV operational efficiency and compliance
  • Liaise with and advise clinical, BDM, QA, regulatory and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the company
  • Ensure consistency in collection, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in Takeda global processes.
  • Represent Pharmacovigilance Operations on global teams
  • Define the standard for safety reporting from clinical trials
  • Oversee activities for SAE reconciliation
  • Support Takeda sponsored clinical trials and development programmes
  • Develop, manage and implement special projects as required by Head Global Pharmacovigilance Operations

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor s required. Degree in scientific/medical field or advanced degree preferred.
  • Demonstrated skills in negotiation and consensus decision making
  • Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements.
  • Good cross cultural understanding and experience
  • Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments.
  • Ability to review, analyse, interpret and present complex data to a high standard
  • Understanding of and contribution to Takeda business needs and global strategy
  • Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.
  • Good level of computer literacy with Microsoft applications
  • Excellent organisation skills and ability to prioritize individual and departmental workloads.
  • Multi-tasking with the ability to successfully manage multiple critical issues simultaneously

TRAVEL REQUIREMENTS:

  • Some travel to global Takeda sites may be required.

  • WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
  • Empowering Our People to Shine

    Learn more at takedajobs.com.

    Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

    No Phone Calls or Recruiters Please.

    #LI-KL1

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
  • Empowering Our People to Shine

    Learn more at takedajobs.com.

    Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

    No Phone Calls or Recruiters Please.

    #LI-KL1


Please visit our website at takedajobs.com

 
 


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