Posted to MedZilla on 3/30/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Global Reporting Submissions 1602587-MZ


 
 

OBJECTIVES:

  • Leads and provides direction for expedited reporting requirements and processes for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs and Ethics Committees in collaboration with Global Standards and Compliance
  • Leads the strategy and execution of business processes, accountability and development of policies, procedures and tools to facilitate efficient operations and compliant reporting of ICSRs to regulators, LOCs and internal and external partners and vendors
  • Ensures the integrity of reporting rules in the safety database to enable compliant ICSR reporting.

ACCOUNTABILITIES:

  • Provide leadership and oversight to vendors performing ICSR submissions for Takeda ensuring adverse event information is processed according to company timelines and quality standards.
  • Manage and oversee Takeda requirements for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs and Ethics Committees; Ensure accuracy of safety system configuration against the reporting requirements.
  • Responsible for communication and collaboration with Global PV functions and regulatory intelligence to assist with seamless systems for compliant reporting to Health Authorities
  • Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to Global Health Authorities, alliance partners, LOCs, ECs, vendors and investigators and development of and implementation of a methodology for regular quality assessments.
  • Oversee and manage communication with alliance partners, vendors, CROs and internal partners regarding the evaluation and processing of ICSRs
  • Represent Global Pharmacovigilance Operations in internal audits and Health Authority inspections related to global expedited reporting and submissions
  • Approve Alliance Partner safety data exchange agreements for appropriate ICSR safety reporting processes and exchanges ensuring compliance with global expedited reporting requirements.
  • Responsible for update of reporting requirements and ensuring the Global Safety Database configuration is updated with new or revised Alliance Partner safety data exchange agreements requirements
  • Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, reporting reference materials and metrics
  • Monitor performance, accuracy, compliance, and training on Global Expedited Reporting and Submissions at a global level
  • Lead PV relationship with the PV BPO Vendor and/or vendors performing PV Processes and Global Expedited Reporting and Submissions to ensure compliance with SLAs
  • Support LOCs in PV tasks responding to queries and requests regarding case handling and expedited reporting
  • Establish and manage vendor oversight procedures
  • Partner with QA to establish and manage vendor quality agreement procedures related to PV Processes and Global Expedited Reporting and Submissions.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelors required. Advanced degree in scientific/medical field preferred.
  • Good cross cultural understanding and experience
  • Experience in matrix management and well developed skills in teambuilding, motivating and developing people.
  • Demonstrated skills in negotiation and consensus decision making
  • Critical thinking and analytical skills and ability to make key decisions
  • Demonstrated effectiveness in external partner relationship management
  • Understanding of medical/scientific terminology
  • Excellent knowledge of PV regulations for the global pre- and post-market
  • Experience with safety databases, including search and code dictionaries and performing expedited E2B reporting to regulatory authorities
  • Excellent written/oral communication skills
  • Accuracy and attention to detail
  • Flexible mindset
  • Team worker with collaborative approach
  • Ability to prioritize under pressure
  • Well developed organizational skills

PHYSICAL DEMANDS:

Routine demands of an office based environment.
TRAVEL REQUIREMENTS:

Some travel to global Takeda sites may be required.


*LI-PG1-USA

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx


Schedule

Please visit our website at takedajobs.com

 
 


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