Medical Reviewer Case Processing (Manager)
Medical Reviewer Case Processing (Manager)
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Job Description
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 Details
Conduct Medical Review and assessment of ICSRs 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 safetyrelevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service.
Maintain good knowledge of databases regulations guidelines and SOPs.
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.
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Qualification experience & skills:
Degree in Medicine. PG degree in any discipline is an advantage but not mandatory.
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety.
Strong interpersonal and organizational skills to be a good team player.
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.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: PharmaLex India Private LimitedEqual Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are nondiscriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
Employment Type
Full-Time
