Anchal Shukla

Senior Manager - International Pharmacovigilance (Ipv) @MSD

Gurugram, HR, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2022 — Present

Senior Manager - International Pharmacovigilance (Ipv) @MSD

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Gurugram, IN

Responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring.• Responsible for PV activities for India and Neighbouring countries (Bangladesh, Bhutan, Nepal, Maldives, Pakistan and Sri Lanka): PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned.• Serving as a Back-up (BU) local Qualified Person for PV (QPPV)/BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation (Deputy Pharmacovigilance Officer Incharge).

SKILLS

Clinical ResearchHealthcareCROIchPharmaceutical IndustrySopFdaDrug SafetyPsursClinical TrialsGcpClinical Data ManagementClinical MonitoringRegulatory SubmissionsEdcMeddraCtmsSignal ProcessingIch-GcpPatient RecruitmentProtocolPharmacovigilanceMedical WritingQuality Control

ABOUT ANCHAL SHUKLA

Pharmacovigilance professional with 11 years of work experience with major pharmaceutical…

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