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Sun Pharma

QA Pharmacovigilance Executive

Sun Pharma

Gurugram, Haryana, India ・ フルタイム

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経験
2年
給料
求人情報
1
投稿済み
2週間前
作業モード
在任中
教育
M. Pharma or BDS
資格
Candidates with a postgraduate pharmacy qualification (M. Pharma) or BDS and around 2 years of relevant experience in pharmacovigilance quality assurance, PSUR, or signal management can apply.
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勤務地

仕事内容

Role Overview

This position sits within Sun Pharma’s R&D Quality Pharmacovigilance QA team in Gurgaon, where the focus is on maintaining compliant, inspection-ready pharmacovigilance quality systems. The role is at Executive level and contributes to audit management, quality oversight, documentation control, and cross-functional coordination.

About the Workplace

Sun Pharma describes its culture as one that encourages people to build their own path, improve continuously, take ownership, and succeed through teamwork. The organization emphasizes steady growth, collaboration, and a supportive environment.

Key Responsibilities

  • Support the creation of a global pharmacovigilance audit framework and take part in planning, conducting, and documenting audits as a lead auditor or co-auditor for CROs, vendors, service providers, affiliates, and partners connected to pharmacovigilance operations.
  • Carry out and document audits of Sun Pharma sites involved in pharmacovigilance activities to confirm that quality systems are being followed properly.
  • Manage the Internal Audit Observation Database and circulate audit reports, CAPA updates, and observations with global and regional pharmacovigilance teams as needed.
  • Follow up on CAPAs to make sure they are addressed effectively and formally closed.
  • Review deviations raised at global and regional levels and ensure the linked CAPA responses are appropriate and complete.
  • Check pharmacovigilance SOPs for accuracy, completeness, clarity, and alignment with global and regional policies as well as applicable regulations and guidelines.
  • Draft and review departmental SOPs.
  • Contribute to monthly reporting activities.
  • Maintain training records for the GPvP-QA team through the LMS.
  • Assist the operations team during corporate and external audits.
  • Work with cross-functional teams to uphold quality standards across pharmacovigilance processes.
  • Track global actions, monitor progress, and support assessment of actions tied to corporate initiatives.
  • Handle additional tasks related to the R&D quality system as assigned.
  • Keep records and documentation aligned with quality expectations and regulatory requirements.

Requirements

  • Postgraduate qualification in Pharmacy (M. Pharma) or a BDS degree.
  • About 2 years of experience in pharmacovigilance quality assurance, or 2 years of experience in PSUR or signal management.
  • Strong audit capability and attention to detail.
  • Clear spoken and written English communication skills.

Additional Information

This job summary is intended to describe the general nature and level of work expected in this role. It is not a complete list of all duties, responsibilities, or qualifications. The employer may adjust responsibilities over time or assign similar tasks based on business need and the incumbent’s background.

Benefits and Growth

Sun Pharma highlights opportunities for professional development, collaboration, and long-term impact, along with a workplace that supports both personal and career growth.

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