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!
Responsibilities:
Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
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 objective setting and annual appraisals of staff
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 SDEA’s, 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
Submission of ICSRs to Health Authorities and partners of a client
Case completion / documentation.
Identify potential risks in case processing workflows, Develop mitigation strategies
Implement robust quality control mechanisms
Ensure adherence to legal, regulatory and partner compliance
Interface with other departments like VDC office, QPPV office, compliance, and other relevant internal departments
Develop and implement comprehensive case processing strategies
Design and optimize workflow procedures to enhance efficiency and accuracy
Prepare comprehensive management reports
Develop dashboards and visual representations of operational performance
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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Education:
University degree in Life Science
Experience:
Minimum 10 years of experience and profound knowledge in the field of pharmacovigilance
Skills:
Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.
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 timeCencora 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 company’s 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned