Safety Supervisor Genius Express Services Pvt Ltd

2.0 - 6.0 years

0 Lacs

bhubaneswar

On-site

As a Safety Compliance and Risk Management professional, your role will involve ensuring adherence to local, state, and federal electrical safety regulations. You will be responsible for conducting regular safety audits and inspections of electrical systems and equipment to identify potential hazards and implement corrective actions. Additionally, you will perform risk assessments, provide recommendations to mitigate risks, and investigate incidents and near-misses related to electrical systems. Key Responsibilities: - Ensure adherence to local, state, and federal electrical safety regulations - Conduct regular safety audits and inspections of electrical systems and equipment - Identify pote...

Posted 1 day 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...

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Executive - Pharmacovigilance Piramal Pharma Limited

1.0 - 4.0 years

0 - 2 Lacs

Mumbai, Maharashtra, India

On-site

Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly information system. Assist in responding ...

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Senior Executive Piramal Pharma Limited

1.0 - 3.0 years

0 - 3 Lacs

Mumbai, Maharashtra, India

On-site

Job description Business: Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No Reporting Structure Reports to Manager Essential Qualification Bachelors/ Masters degree in Pharmacy Experience Overall 2-3 years of experience in Pharmacovigilance with at least 1 year of relevant work experience in ICSR processing, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc. Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mai...

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Asst. Manager Medical Writing DDReg Pharma Pvt. Ltd.

3.0 - 7.0 years

0 Lacs

haryana

On-site

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specificati...

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The cleaned title is Assistant Manager Medical Writing DDReg Pharma Pvt. Ltd.

3.0 - 7.0 years

0 Lacs

haryana

On-site

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the deli...

Posted 2 months ago

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Life Science : Submissions Publisher : Apply Now Outpace Consulting Services

2 - 5 years

6 - 10 Lacs

Noida

Work from Office

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexitie...

Posted 4 months ago

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