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Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature
Provision of scientific input in the course of literature surveillance service
Maintain good knowledge of databases, regulations, guidelines and SOP’s
To actively communicate and participate in internal project meetings
Participation in internal and external audits/inspections
Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs
Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes
Perform any other drug safety related activities as assigned
Requirements:
Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory
Nice to have:
PG degree in any discipline
Previous exposure to corporate environment, pharma and life sciences industry