Vendor Compliance Specialist

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 28,00,000

Job Summary

We are seeking a highly skilled Vendor Compliance Specialist to join our team. This role is responsible for ensuring that vendors comply with approved processes and training requirements.

About the Role

  • Support interactions with business partners and vendors for all case intake and processing activities.
  • Oversight of vendor compliance with approved processes and training requirements.
  • Submission of individual case safety reports to regulatory authorities and business partners.
  • Act as local safety office and point of contact for safety reporting.
  • Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally.
  • Ensure vendors deliver high-quality cases through metric management.
  • Provide vendors with resources and training to perform their role.
  • Analysis and communication of case Quality Control results.
  • Escalation of case-related issues from vendors.
  • Providing audit/inspection support for case management related activities.
  • Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV).
  • May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics.

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.
  • 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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