Senior Specialist Case Processing
Senior Specialist Case Processing
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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
Performing triage and review for initial validity assessment of cases including spontaneous health authority Clinical Trial and literature cases.
Responsible for quality management workload management compliance management and document management for the assigned PV projects
Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned including reporting timelines
Preparation of standard reporting forms (e.g. CIOMS I / MedWatch Forms and XML files)
Preparation and sending of followup requests
Submission of ICSRs to Health Authorities and partners of a client
Acts as line manager of assigned staff
Manages project coordination and resource allocation within the projects
Train and mentor PV department staff as needed
Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
Responsible for recruitment of new staff in PV Department
Ensures all departmental CVs job descriptions and training records are complete and up to date and as per SOPs
Is involved in goal setting and annual appraisals of staff
Participate in the goal-setting process and conduct annual appraisals for staff providing constructive feedback and support to foster individual development and align team objectives with organizational goals.
Ensures training compliance by PV staff at all times
Represents PV department during for-cause/maintenance client audits or regulatory authority inspections
Ensure compliance with internal standards and external (national and international) regulations
To write/ review QA documents such as SDEAs Working Instructions SOPs Working Procedures templates project metafiles etc. for PharmaLex Pharmacovigilance projects
To organize and perform training of the above-mentioned documents
Case processing including data entry and QC
Case completion / documentation.
Actively mentor and support new joiners by providing guidance on company processes facilitating their integration into the team and fostering a collaborative learning environment to enhance their professional development.
Responsibilities will be assigned by the supervisor in accordance with process requirements.
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To write/ review QA documents such as SDEAs Working Instructions SOPs Working Procedures templates project metafiles etc. for PharmaLex Pharmacovigilance projects
To organize and perform training of the above-mentioned documents
Case processing including data entry and QC
Case completion / documentation.
Actively mentor and support new joiners by providing guidance on company processes facilitating their integration into the team and fostering a collaborative learning environment to enhance their professional development.
Responsibilities will be assigned by the supervisor in accordance with process requirements.
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 non-discriminatory.
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 request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Senior IC
Employment Type
Full-Time
