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COD Research Hiring Aggregate Report Writer
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#794751
Remote / WFH
COD Research
Job Description
COD Research is hiring an Aggregate Report Writer for its Patient Safety department in Ahmedabad. The position is open to Life Science graduates and postgraduates with 1 to 6 years of experience in aggregate reports or medical safety. The role involves preparing and reviewing PSURs, DSURs, and PBRERs, along with literature searches, signal detection, regulatory intelligence, and pharmacovigilance compliance activities. Candidates will also work with internal and external stakeholders and support audits, regulatory inspections, SOP preparation, and quality activities.
COD Research Hiring Aggregate Report Writer
Company: COD Research
Position: Aggregate Report Writer
Department: Patient Safety
Location: Ahmedabad
Employment Type: Full Time, Permanent
Openings: 1
Experience: 1–6 years
Job Description
Key Responsibilities
• Prepare, update, and quality review aggregate reports and safety documents, including PSURs, DSURs, and PBRERs.
• Be responsible for the generation of applicable line listings from the safety database and literature screening for inclusion, as applicable.
• Perform literature searches for aggregate reports and signal detection, as applicable.
• Review and identify case reports and AOIs from literature and regulatory sources, as applicable.
• Maintain awareness of changes to regulations and new regulations affecting pharmacovigilance activities, as applicable.
• Provide inputs into the preparation of regulatory actions in response to emerging safety concerns, such as variations, urgent safety restrictions, and communication to patients and healthcare professionals, as applicable.
• Consult and communicate with multiple internal and external stakeholders, including sponsors, clients, medical monitors, and pharmacovigilance physicians, to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable.
• Participate in audits and regulatory inspections in cooperation with QA, as needed.
• Review and prepare SOPs, WIs, guides, and training materials, and provide inputs to SOPs, as applicable.
• Provide various quality and compliance-related data/documents or any other data/documents/evidence required for the oversight and management of pharmacovigilance activities, as applicable.
• Screen and review regulatory intelligence to identify changes to or new regulations affecting pharmacovigilance activities.
• Communicate new or changed regulations to management and relevant team members of the department to initiate any required changes in processes, as applicable.
Qualifications & Experience Required
• Life Science Graduate/Post-Graduate.
• 1 to 6 years of experience in Aggregate Reports/Medical Safety.
Education Qualification
Undergraduate
B.Pharma in Any Specialization
Postgraduate
M.Pharma in Any Specialization
Key Skills
• Aggregate Reporting
• PBRER
• PSUR
• DSUR
• Medical Safety
• Pharmacovigilance
• Literature Search
• Signal Detection
• Regulatory Intelligence
About COD Research
COD Research is an organization assisting pharmaceutical, biotechnology, medical device, and vaccine companies with their pharmacovigilance and clinical research priorities globally.
COD Research is established in India and the USA and provides clinical trial solutions with a focus on research. Its global pharmacovigilance process includes safety management planning, safety reporting, risk assessment, regulatory reporting, and collection of appropriate evidence from laboratory reports and related clinical evidence.
How to Apply
Interested and eligible candidates can apply for the Aggregate Report Writer position through the job application provided by COD Research on Naukri.
Apply Online:
https://www.naukri.com/job-listings-aggregate-report-writer-cod-research-ahmedabad-1-to-6-years-110826038610
Job Summary
Company
COD Research
Vacancies
Aggregate Report Writer
Required Education
B.Pharma / M.Pharma or Life Science Graduate/Post-Graduate
Experience
1–6 years in Aggregate Reports / Medical Safety
COD Research Hiring Aggregate Report Writer
Company: COD Research
Position: Aggregate Report Writer
Department: Patient Safety
Location: Ahmedabad
Employment Type: Full Time, Permanent
Openings: 1
Experience: 1–6 years
Job Description
Key Responsibilities
• Prepare, update, and quality review aggregate reports and safety documents, including PSURs, DSURs, and PBRERs.
• Be responsible for the generation of applicable line listings from the safety database and literature screening for inclusion, as applicable.
• Perform literature searches for aggregate reports and signal detection, as applicable.
• Review and identify case reports and AOIs from literature and regulatory sources, as applicable.
• Maintain awareness of changes to regulations and new regulations affecting pharmacovigilance activities, as applicable.
• Provide inputs into the preparation of regulatory actions in response to emerging safety concerns, such as variations, urgent safety restrictions, and communication to patients and healthcare professionals, as applicable.
• Consult and communicate with multiple internal and external stakeholders, including sponsors, clients, medical monitors, and pharmacovigilance physicians, to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable.
• Participate in audits and regulatory inspections in cooperation with QA, as needed.
• Review and prepare SOPs, WIs, guides, and training materials, and provide inputs to SOPs, as applicable.
• Provide various quality and compliance-related data/documents or any other data/documents/evidence required for the oversight and management of pharmacovigilance activities, as applicable.
• Screen and review regulatory intelligence to identify changes to or new regulations affecting pharmacovigilance activities.
• Communicate new or changed regulations to management and relevant team members of the department to initiate any required changes in processes, as applicable.
Qualifications & Experience Required
• Life Science Graduate/Post-Graduate.
• 1 to 6 years of experience in Aggregate Reports/Medical Safety.
Education Qualification
Undergraduate
B.Pharma in Any Specialization
Postgraduate
M.Pharma in Any Specialization
Key Skills
• Aggregate Reporting
• PBRER
• PSUR
• DSUR
• Medical Safety
• Pharmacovigilance
• Literature Search
• Signal Detection
• Regulatory Intelligence
About COD Research
COD Research is an organization assisting pharmaceutical, biotechnology, medical device, and vaccine companies with their pharmacovigilance and clinical research priorities globally.
COD Research is established in India and the USA and provides clinical trial solutions with a focus on research. Its global pharmacovigilance process includes safety management planning, safety reporting, risk assessment, regulatory reporting, and collection of appropriate evidence from laboratory reports and related clinical evidence.
How to Apply
Interested and eligible candidates can apply for the Aggregate Report Writer position through the job application provided by COD Research on Naukri.
Apply Online:
https://www.naukri.com/job-listings-aggregate-report-writer-cod-research-ahmedabad-1-to-6-years-110826038610
Job Summary
Company
COD Research
Vacancies
Aggregate Report Writer
Required Education
B.Pharma / M.Pharma or Life Science Graduate/Post-Graduate
Experience
1–6 years in Aggregate Reports / Medical Safety
