Indegene Hiring Associate—Quality Assurance Life science postgraduate Apply Now
Job Description:
The roles and responsibilities of an Associate—Quality Assurance
include the following:
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
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