12 Safety Reports Jobs

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer techn...

As a Safety Compliance and Risk Management professional, your role involves 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. - Develop and implement electrical safety policies and procedures - Conduct safety training sessions for employees - Create educational materials and programs to enhance safety awareness - Stay updated o...

As a Regulatory Affairs Specialist, you will be responsible for preparing and maintaining Aggregate Safety Reports (ASRs) in compliance with regulatory guidelines. Your key responsibilities will include: - Collaborating with cross-functional teams to gather necessary data and analyses. - Ensuring compliance with applicable regulations and internal policies. - Identifying and assessing safety signals, and reporting findings to relevant stakeholders. - Reviewing and interpreting clinical trial data and safety information. - Assisting in the preparation and submission of regulatory documents to health authorities. - Providing expert advice and guidance on regulatory matters. - Identifying poten...

Job Description: As a Medical-Regulatory Writer Assistant Manager, your main responsibility will be to plan and manage Medico-Regulatory Writing in accordance with relevant Regulatory Guidelines. You will be expected to deliver high-quality medical and scientific writing, provide technical consultation and advice on strategy and regulations, demonstrate subject matter expertise, effectively manage writing projects to meet deadlines, collaborate with internal and external clients, and produce various types of reports including CTD Modules, Safety Reports, and Aggregate Reports. Key Responsibilities: - Conduct science reviews of aggregate reports - Ensure document compliance with client specif...

As a member of the team at Cencora, you will play a crucial role in creating healthier futures for people and animals everywhere. Your responsibilities will include: - Performing triage and review for initial validity assessment of cases, such as spontaneous, health authority, Clinical Trial, and literature cases. - Data entry into the PV database. - Conducting initial ICSR assessment, when applicable. - Evaluating the need for expedited reporting to Health Authorities or partners of a client, including reporting timelines. - Preparing standard reporting forms like CIOMS I/MedWatch Forms and XML files. - Sending follow-up requests and submitting ICSRs to Health Authorities and partners of a ...

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...

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...

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 ...

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...

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...

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...

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...