Skills

DRUG REGULATORY AFFAIRS FRESHER

I am a pharmacy professional with Mater in pharmacy and Diploma in Drug Regulatory Affairs. I have one year seven months experience in pharmacovigilance department and want to switch my career in Drug Regulatory Affairs as I have keen interest in Regulatory domain. I have sound knowledge of international Regulatory authorities USFDA, EMA, DMF, Dossier, test license, import license, BE NOC.

 I am a hardwoking, self motivating and enthusiastic professional if given a chance would definitely prove to be an asset for the company.

Refrences

I have worked as Drug Safety Associate. My job roles included

Processing Individual Case Safety Report (ICSRs) from variety of sources, health authority reports and spontaneous reports
Performing initial triage of received source documentation and determining whether they have a safety component, a Medical Information Request (MIR), or an Adverse Events (AE).
Validity assessment and seriousness assessment of ICSRs
Maintaining Client AE Inbox
Following up with reporters ICSRs, including generating follow queries, and sending follow up requests Accepted E2B cases received through Argus Electronic Submission Module (ESM)
Performing duplicate check using fields of ARGUS.
Performing triage of incoming source documentation Performing data entry ICSRs onto the safety database and MedDRA coding
Contributed to maintenance and compliance of pharmacovigilance activities.

Time and Spatial Flexiblity

Prefferably gurgaon

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