ROW Market Pharmacovigilance Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeePharmacovigilance Full time US$ 90,000 - US$ 1,20,000

Job Summary

We are seeking a highly skilled and detail-oriented Pharmacovigilance Specialist to join our organization. The ideal candidate will have excellent communication and organizational skills, as well as a strong understanding of regulatory requirements in ROW countries.

Key Responsibilities:

  • Manage pharmacovigilance tasks, including updating PSMFs, collaborating with partners to create SDEAs, and ensuring compliance with SDEA requirements.
  • Keep activity tracking spreadsheets up-to-date to ensure all tasks are consistently monitored and recorded.
  • Manage the Eudravigilance database and perform signal detection activities as required.
  • Manage RMP queries and CMDh risk notifications.
  • Update RMPs post-authorization and track related variations with RA.
  • Ensure compliance for aggregate reports, including PSUSAs, for regulatory intelligence and tracking tasks to be addressed in the next PSUR.
  • Manage deviations and CAPAs: Identify and report any deviations in procedures and participate in CAPA development, assuming responsibility for CAPA completion when assigned.
  • Provide support during audit and inspection preparation, actively participate during audits, address any observations, and assist in CAPA closure.

Relationship Management:

  • Work with other regional teams and central cross-functional teams across the globe.
  • Interact with vendors/service providers for PV activities.

Process Improvement/Standardization:

  • Participate in process improvement initiatives under supervision of Head of Pharmacovigilance of respective region.

Qualifications:

Desired Skills & Competencies:

  • Bachelor's degree in pharmacy, Master's degree is preferred.
  • Minimum 8 years of experience in pharmacovigilance out of which at least 3 years in core pharmaceutical company.
  • Strong understanding of regulatory requirements and guidelines of respective countries.
  • Excellent communication and organizational skills.
  • Proficiency in Microsoft Office, including Excel, PowerPoint.
  • Ability to work independently and as part of a team.
  • Detail-oriented and able to manage multiple tasks simultaneously.

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