About the role:

How you will contribute:

• Identify potential Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them
  
• Perform tasks of daily study specific activities including SAE reconciliation, study set up, TMF filing
  
• Perform certain key tasks to ensure high data quality and efficiency
  
• Support study specific Inspection and Audit requests pertaining to their program
  
• Conduct sample quality review of outsourced activities including SAE Reconciliation, e TMF filling, SAE Forms and completion instructions
  
• Review and create Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation within their program
  
• Maintain knowledge of PV Regulations and global industry practices for PV operational efficiency and compliance
  
• Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs, 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 to optimize evaluation of safety data stemming from clinical trials
  
• Represent Pharmacovigilance Operations on Global Program/study teams
  

Minimum Requirements/Qualifications:

• Bachelor’s required. Degree in scientific/medical field or advanced degree preferred.
  
• 8+ years of related pharmaceutical industry experience required.
  
• Experience in SAE reconciliation and safety management plans.
  
• Demonstrated skills in negotiation and consensus decision making.
  
• Expert knowledge of clinical trial and Pharmacovigilance methodologies including 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, analyze, 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 organization skills and ability to prioritize individual and departmental workloads.
  
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously.
  
• Take the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness of GPSE processes and standards.
  

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