ICSR Subject Matter Expert (SME)
ICSR Subject Matter Expert (SME)
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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
The Subject Matter Expert (SME) in Pharmacovigilance (PV) outsourcing is crucial in ensuring the safety and efficacy of pharmaceutical products by overseeing and guiding PV processes. This role demands extensive knowledge of drug safety regulations risk management strategies and the capability to lead teams in adherence to industry standards. It is pivotal in maintaining the integrity of drug safety practices within the PV outsourcing sector ensuring all activities comply with regulatory standards while promoting a culture of safety and quality within the organization.
Description:
Lead Quality & Compliance initiatives in highvolume ICSRs projects.
Strategic planning implementation and execution in highvolume ICSRs services.
Collaborate closely with client and Delivery Head to ensure seamless project execution.
Evaluate projectspecific data workstreams and process controls periodically to support informed decisionmaking.
Ensure project readiness by providing realtime floor support for query resolution and ICSR processing guidance.
Liaise with clients on technical calibration regarding quality and compliance discussions.
Lead and guide project teams during daily huddles and operational discussions.
Assist delivery teams in proactive issue management to prevent potential problems.
Create and implement innovative business solutions for improved cost management and efficiency while maintaining high compliance in pharmacovigilance.
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Oversight of PV Operations
Regulatory Compliance
Training and Development
Data Management
Stakeholder Communication
Quality Assurance
Excellent Communication
Experience in Pharmacovigilance
Graduate/Postgraduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or
equivalent degrees.810 years of relevant experience in Pharmacovigilance with 35 years in team handling peoplemanagement and project management.
Proficient organizational skills with the ability to manage multiple complex projects/tasks at the
same time.
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
Employment Type
Full-Time
