Rudra Adhik Khanolkar

Pharmacovigilance Intern · Bayer Zydus Pharma Pvt. Ltd.

0years’ experienceLinkedIn

About

As a Bachelor of Pharmacy graduate from Mumbai University with direct corporate pharmacovigilance experience at Bayer Zydus Pharma, I am highly motivated to apply for the Benefit/Risk Associate II position. I am fully equipped to contribute to your Benefit-Risk Management team immediately, bringing the following credentials:Practical PV Experience: Managed Individual Case Safety Reports (ICSRs), tracked patient demographics, and processed suspect reaction logs during my Bayer Zydus internship. Database & Coding Proficiency: Certified in Oracle Argus Safety Database workflows and MedDRA Standard Coding Hierarchy protocols. Compliance Grounding: Certified in ICH Good Clinical Practice E6(R3), with a strong background in clinical narrative writing and data cleaning using advanced Excel analytics. Flexibility: Based in Maharashtra and fully available for your Pune office or a remote arrangement.My baseline industry training allows me to hit the ground running with minimal onboarding

Looking for

Pharmacovigilance associate, Pharmacovigilance trainee, Regulatory Affairs associate, Quality Control associate, Clinical data management, clinical research associate

Skills

Oracle Argus Safety DatabaseICSR ProcessingAdverse Event (AE) TriagePatient Safety SurveillanceSerious Adverse Event (SAE) LoggingDrug Regulatory Affairs (DRA)FDA/EMA Global Compliance FrameworksCorporate SOP AlignmentGxP StandardsMedDRA Medical CodingWHO Drug Dictionary (WHO-DD)Clinical Data Management (CDM)Database ValidationAdvanced Microsoft ExcelICH-GCP (E6 R3)Clinical Narrative WritingCommunicationLeadership

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