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Associate—Quality Assurance Full-time Job

1 week ago Pharma Bengaluru   15 views
Job Details

Job Description:

  • Performing QA review of the Periodic Safety Reports (PBRER, DSUR, RMP, etc.) against the applicable source documents provided by clients
  • Finding out discrepancies in the Periodic Safety Reports against the source documents and categorizing these observations into critical, major, and minor findings
  • Interfacing with clients on a regular basis to meet their expectations
  • Communicating the QA observations to the applicable stakeholders and ensuring the appropriate RCA/CAPA is obtained from the respective stakeholders for the applicable QA observations as per the client requirements
  • Presenting the QA data to the responsible stakeholders in an appropriate forum as required
  • Adhering to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards, requirements, and policies
  • Communicating and interacting effectively within and across client key stakeholders and within internal team management as appropriate
  • Attending all the internal trainings and client trainings and ensuring compliance with applicable guidelines
  • Being responsible for all content milestone deliverables such as quality and accuracy, timeliness, and efforts

Desired Skills and Experience:

  • Education—Life science postgraduate with 2-3 years of experience in pharmacovigilance, ICSR (case processing/data entry/quality review), and quality assurance
  • Preferably with a hands-on experience in Argus Safety Database
  • Understanding of root cause and CAPA process associated with ICSR
  • Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field
  • Strong written and verbal communication/presentation skills
  • Passion for networking
  • Being up to date with the latest technical/scientific developments and relating them to various projects

Selection Process: The selection will be on the basis of Interview.

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Company Description
Indegene Inc. is a company offering research and development and management services to healthcare and pharmaceutical enterprises. It was founded in 1998 and is based in Bangalore, India. Indegene has offices in North America, Europe, China and India.