Job Description:
Quality check and review of individual case safety reports (ICSRs) based on accepted industry and regulatory guidelines.
Write various safety reports for global regulatory submissions including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events.
Review of literature search output or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Overview compliance of ICSR with governing regulatory requirements
Skills
Masters degree in Pharmacy or Life sciences with at least 3-4 years of experience in the pharmacovigilance.
Prior experience of ICSR processing in pharmacovigilance/drug safety field.
Experience of aggregate report writing specially PBRER.
Familiarity with the global reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities.
Strong written and verbal language skills
Ability to analyze and synthesize medical information.
Eye for quality, detail orientation for various pharmacovigilance processes.
Recruiter Name:Venkat Vishwanath
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