3.0 - 7.0 years

0 Lacs

pune, maharashtra

On-site

Medical Writer II (CSR Narrative exp Only) at Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. In our Clinical Development model, the customer and the patient are at the core of everything we do. We are constantly seeking ways to simplify and streamline our work to not only enhance the ease of collaboration with Syneos Health but also to make working for us more straightforward. Whether you are part of a Functional Service Provider partnership or a Full-Service en...

Posted 4 weeks ago

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Periodic Report QC Reviewer Amgen Technology Private Limited

1.0 - 9.0 years

3 - 12 Lacs

Hyderabad, Telangana, India

On-site

Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checkl...

Posted 2 months ago

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Appraisal QC Consolidated Analytics

2.0 - 6.0 years

0 Lacs

chennai, tamil nadu

On-site

Job Description: As an Appraisal QC Reviewer in the Valuation/Appraisal QC department located in Chennai and working in the US Shift, you will report to the Team Lead. With 2-3 years of relevant experience and excellent communication skills, we are looking for candidates who can join with an immediate to 1-month notice period. In this role, you will be responsible for conducting detailed reviews of residential real estate appraisal reports. Your primary tasks will include ensuring accuracy, consistency, and completeness in the reports. You will need to identify any discrepancies, inconsistencies, or red flags and effectively communicate with internal teams or appraisers for clarification or ...

Posted 2 months ago

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Document Review Services Team Lead (Contract Management) Epiq

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

You are a dedicated and experienced Team Lead for the Document Review Services team at Epiq Global in Hyderabad, India. Your expertise in e-discovery, legal analysis, and project management will be crucial for overseeing document review projects, maintaining quality standards, and ensuring timely delivery aligned with client expectations. Your responsibilities include reviewing documents for relevancy, privilege, and other issues as directed by clients, conducting research on technical and industry-specific matters, drafting reports and findings, participating in QC reviews, creating complex searches, establishing review workflows based on client requirements, managing document review projec...

Posted 2 months ago

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Assistant Manager- Analytical QA ( Qc reviewer + QMS) OSD Hr Services Chandigarh

11 - 15 years

10 - 15 Lacs

Chennai

Work from Office

Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and p...

Posted 5 months ago

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