Safety Writer

1 week ago

Navi Mumbai, India Labcorp Full time

Labcorp Drug Development

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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Job responsibilities

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables

Ensure compliance of operations with governing regulatory requirements

Create, maintain and assume accountability for a culture of high customer service

Efficiency in conducting literature searches for authoring various types of reports

Author/review various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.

Perform/review Signal detection activities

Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports

Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs

Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document

Author/review SOPs/WIs/process documents or sections as applicable

Impart/conduct Trainings for peers and team members

Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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