- Vendor Oversight & Quality Assurance: You will oversee vendor activities, ensuring the quality of Individual Case Safety Reports (ICSRs) processed globally. This includes performing retrospective quality assurance, analyzing and reporting on QC trends, and managing vendor-related issues.
- Compliance & Training: Ensure vendors comply with approved processes and training requirements. You will provide vendors with the necessary resources and training and support the on-boarding and off-boarding of vendor staff.
- Safety Reporting & Regulatory Support: Submit all individual case safety reports to regulatory bodies like the FDA/EMA and business partners. You will act as a local safety office point of contact and provide essential support during audits and external inspections.
- Metrics & Analysis: Generate and distribute performance metrics related to retro QA and case corrections. You will also support the analysis of QC trends, including recommendations and actions to improve case quality.
- A Bachelor's degree with 3 years of directly related experience, an Associate's degree with 5 years of experience, or a High School diploma/GED with 7 years of experience.
- Previous experience managing teams, projects, or programs, or directing the allocation of resources.
- Expertise in safety case processing and a strong understanding of global regulatory requirements for pharmacovigilance.
- Experience in all aspects of case intake and processing in multiple global safety databases.
- Experience in supporting inspections or internal audits is preferred.
- Proficiency in Microsoft Suite (Word, Excel, PowerPoint, Project, Outlook).
- Communication: Strong communication skills and the ability to interact with business partners, vendors, and other local safety offices.
- Attention to Detail: Meticulous attention to detail to ensure the quality of case processing and accurate reporting.
- Initiative: A high degree of initiative and self-motivation to undertake delegated activities and ensure inspection readiness.
- Problem-Solving: The ability to escalate and resolve case-related issues from vendors effectively.
-
Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors · Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements · Provid ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Diensten Tech Limited is looking for Senior Associate Operations to join our dynamic team and embark on a rewarding career journey · An Associate - Operations is responsible for supporting and improving the day-to-day operational activities of a company · They may perform tasks s ...
Hyderabad / Secunderabad, Telangana ₹500,000 - ₹1,200,000 (INR) per year Full time4 days ago
-
Diensten Tech Limited is looking for Junior Associate Operations to join our dynamic team and embark on a rewarding career journey · An Associate - Operations is responsible for supporting and improving the day-to-day operational activities of a company · They may perform tasks s ...
Hyderabad / Secunderabad, Telangana Full time4 days ago
-
Job description · Corporate Quality: · To Lead the Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. · To pa ...
Hyderabad / Secunderabad, Telangana Full time4 days ago
-
Responsibilities: · Analyze, evaluate, and issue purchase request for proposals/quotes as a result of customer requests/requisitions. · Identify and select vendor to procure requisitioned commodities; meeting criteria, such as price, quantity, quality and delivery dates and specs ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Key Responsibilities: · Compliance Management: · Ensure timely renewal and submission of statutory documents such as CLRA Certificate, S&E Certificate, Holiday List, Integrated Annual Returns, Gratuity Form L, and Monthly Registers. · Conduct quarterly audits for notice boards an ...
Hyderabad / Secunderabad, Telangana Full time4 days ago
-
Roles & Responsibilities: · Design and manage governance with Global Procurement vendors to ensure optimal service delivery, compliance, and contract value · Execute vendor management strategies that align with the organizations procurement and business objectives. · Collaborate ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Major Accountabilities: · Ensure site compliance with all statutory requirements such as CLRA Certificate renewal, S&E Certificate renewal, Holiday List management, Integrated Annual Returns, Gratuity Form L, quarterly notice board audits, vendor audits, X6 submissions, and maint ...
Hyderabad / Secunderabad, Telangana Full time4 days ago
-
Role Summary · We are looking for a meticulous and process-driven File Room Specialist to manage the lifecycle of employee records across both physical storage (via an external vendor) and the digital file room leveraging the ServiceNow EDM (Enterprise Document Management) module ...
Hyderabad / Secunderabad, Telangana ₹350,000 - ₹800,000 (INR) per year Full time22 hours ago
-
Key Responsibilities · Physical File Room Management (Vendor Oversight) · Serve as the primary point of contact for the third-party vendor managing off-site physical records storage. · Coordinate record retrievals, returns, and new archival requests in compliance with company pol ...
Hyderabad / Secunderabad, Telangana ₹350,000 - ₹800,000 (INR) per year Full time22 hours ago
-
We are looking for a professional, well-spoken, and sensible Intern to manage vendor communication and feedback collection. The intern will be responsible for reaching out to service vendors associated with our company, conducting structured surveys, collecting feedback regarding ...
Hyderabad / Secunderabad, Telangana ₹180,000 - ₹450,000 (INR) per year Full time22 hours ago
-
As a Cyber and Third-Party Risk Analyst, you will be responsible for identifying, analyzing, and mitigating IT-related risks. This role is critical for ensuring that risk controls are in place, policies are adhered to, and security standards are met across the organization. You w ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
In this vital role, you will be responsible for the Supplier Onboarding process and Vendor Master data oversight and management. This is a leadership position where you will manage a small team of internal staff and an external Business Process Outsourcing (BPO) provider. This ro ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Job Summary Responsibilities : · SAP SuccessFactors Techno-Functional Consultant will play a crucial role in implementing and optimizing the SAP SuccessFactors Human Capital Management (HCM) suite · This role combines technical expertise · with a deep understanding of business pr ...
Hyderabad / Secunderabad, Telangana Full time4 days ago
-
Your role and responsibilities · As a Process Associate – Procure to Pay (P2P), you will be responsible for transaction processing in Accounts Payable and management of Vendor Accounts. You should be flexible to work in shifts. · Your primary responsibilities include: · Coordin ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Roles and Responsibilities: · Preparing plans for the purchase of equipment, services, and supplies. · Following and enforcing the Qualcomm procurement policies and procedures. · Reviewing, comparing, analyzing, products and services to be purchased. · Managing and Maintaining ac ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Key Responsibilities · Install, customize, support, and maintain z/OS and associated IBM/third-party products. · Administer SMP/E product installs and manage Broadcom ESP installations and maintenance. · Debug system and application dumps using IPCS and Abend-aid tools. · Maintai ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
About The Role · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electron ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
Manager, CSAR - Electronic Data Interchange and Acquisition · Role Description · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programmi ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
-
The Manager, CSAR - Electronic Data Interchange and Acquisition · What you will do · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Intercha ...
Hyderabad / Secunderabad, Telangana Full time22 hours ago
Case Management QA Vendor Associate - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
As a Case Management QA Vendor Associate, you will be responsible for the quality and oversight of case intake and processing activities conducted by vendors. This role involves ensuring vendor compliance with approved processes and training requirements, managing relationships with business partners, and supporting safety reporting to regulatory bodies. You will be a key player in ensuring high-quality case processing, meeting all worldwide regulatory requirements, and maintaining a state of inspection readiness.
Roles & Responsibilities
Qualifications
Soft Skills
-
Case Management QA Vendor Associate
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Senior Associate Operations
Full time confidential- Hyderabad / Secunderabad, Telangana
-
Junior Associate Operations
Full time confidential- Hyderabad / Secunderabad, Telangana
-
r - AGM
Full time confidential- Hyderabad / Secunderabad, Telangana
-
Procure-to-Pay Associate Advisor
Full time Cigna Medical Group- Hyderabad / Secunderabad, Telangana
-
Hr Associate 2
Full time confidential- Hyderabad / Secunderabad, Telangana
-
Senior Manager Global Procurement
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Hr Associate 2
Full time confidential- Hyderabad / Secunderabad, Telangana
-
Associate, Human Resource
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Associate, Human Resource
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Quality Analyst Intern
Full time NxtWave Disruptive Technologies- Hyderabad / Secunderabad, Telangana
-
Cyber and 3rd party risk analyst
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Global Supplier Onboarding
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
SAP SuccessFactors Techno-Functional Consultant
Full time confidential- Hyderabad / Secunderabad, Telangana
-
process delivery specialist-procure to pay
Full time IBM- Hyderabad / Secunderabad, Telangana
-
Procurement Executive
Full time Sodexo- Hyderabad / Secunderabad, Telangana
-
Infrastructure Engineering Senior Advisor HIH
Full time Cigna Medical Group- Hyderabad / Secunderabad, Telangana
-
The Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
The Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana