FEATURED JOBExecutive
Cadila Pharmaceuticals Ltd
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Posted: 23 Jun 26
Job Description
Major purpose of the Job:
• Literature Screening activity and its management.
• Coordination, updation and tracking with CRO for clinical trials data and collection of SAEs received from clinical trials.
• Coordination, updation, and tracking with post-marketing safety (PMS) study team for collection of SAEs and AEs.
• Responsible for Quality Control Check of ICSRs in safety database with the objective of achieving in high level of regulatory compliance.
• Submission of ICSRs to ROW regulatory authorities.
• Responsible for Quality Control check of calls and voice mail recording of inquiries (PI, PQC, AE, MI, and General Inquiries) via MICC.
Responsibilities:
1. Compliance:
• CATS (compliance assessment and tracking system) management.
• Maintenance of CAT tracker, Literature tracker, Medical Query Tracker, Quality Control tracker, and SAE tracker.
2. Quality & Compliance Governance:
• Revision/Review of quality system-related Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure that there are clear written procedures in place describing the pharmacovigilance system.
• Management of ad-hoc work/responsibilities as allocated by Head of Pharmacovigilance or designee.
• Participating in any internal audits or external inspections on CPL Global pharmacovigilance functions
3. Signal Management & Risk Evaluation:
• Drafting of Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER), Risk Management Plan (RMPs), and Signal Detection Reports as required.
Job Particulars
Role others
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2912291
Job Category Others
Locality Address
State West Bengal
Country India
About Company
Cadila Pharmaceuticals Ltd
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