Senior Case Management Specialist

2 days ago

Hyderabad, Telangana, India beBeeCaseManagement Full time US$ 1,00,000 - US$ 1,75,000
Senior Case Management Specialist

Job Overview:


The Senior Case Management Specialist will support interactions with business partners and vendors for all case intake and processing activities.


Key Responsibilities:


  • Vendor oversight of all case intake and processing activities and case quality, including analysis and reporting of trends in quality measures.
  • Ensure vendor compliance with approved processes and training requirements.
  • Submission of all individual case safety reports to regulatory authorities, business partners, and vendors.
  • Act as local safety office and point of contact for safety reporting.
  • Provide audit & external inspection support.

Additional Responsibilities:


  • Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors.
  • Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements.
  • Provide vendors with resources and training to perform their role.
  • Analysis and communication of case Quality Control results.
  • Responsible for escalation of case related issues from vendor(s).

What We Expect:


We are looking for a professional who is a detail-oriented team player with excellent communication skills. The ideal candidate will have a strong understanding of global regulatory requirements for pharmacovigilance, proficiency in safety case processing, and expertise in all aspects of case intake and processing in multiple global safety databases.


Requirements:


  • Doctorate degree and 3 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and 8 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Skills:


  • Understanding of global regulatory requirements for pharmacovigilance.
  • Proficiency in safety case processing.
  • Expertise in all aspects of case intake and processing in multiple global safety databases.
  • Experience in supporting inspections or internal audits.
  • Communication skills and attention to detail.

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