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Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Responsibility:
Conduct initial assessment and Medical Review of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment
Review and respond to any queries/comments from the Case Owner in the Safety database
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
To detail any follow-up information that is required and not already noted within the Safety database
To provide documentation of the review and case comments in Safety database in Medical Review workflow
Maintain good knowledge of databases, regulations, guidelines and SOP’s
Maintain strong GPVP and GCP knowledge. Following ICH, EMA and FDA guidelines strongly and implementing them appropriately
To actively communicate and participate in internal project meetings
Participation in internal and external audits/inspections
Perform any other drug safety related activities as assigned by the management
Requirements:
Degree in Medicine
PG degree in any discipline is an advantage but not mandatory
Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure as required
Highly service oriented
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
Good communication skills
Fluent in English- spoken and written
Nice to have:
PG degree in any discipline
Previous exposure to corporate environment, pharma and life sciences industry