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Pharmacovigilance Leader Empirica

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

1 Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools. Performs searches in external drug safety databases (such as FAERS/ Vigibase) for signal confirmation.2 Monitors the clinical safety of projects/products and responds appropriately. 3 Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. Medical review of single case reports will be performed by associates possessing medical degree. 4 Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.5 Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information. 6 Prepares medical input to aggregate clinical safety regulatory reports as required7 Provides input to safety profiling and risk management plan as required 8 Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/ expectedness assessment of adverse event reports as required.9 Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs. 10 Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. 11 Participates in review of clinical study protocols/reports/other regulatory documents as needed.12 Provides relevant input for Global Program/Brand Team (GPT/GBT), Global Clinical Team(GCT), and CTT meetings as needed. 13 Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities as required.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 4-9


Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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