Subject Matter Expert

4 days ago

Pune, 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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Clinical Development | Fortrea

Coordinate activities related to various types of report writing across a team of writers, if applicable Liaise with client and act as a primary point of contact for all report writing activities
- Internal and external (client) communication & co-ordination to get the required inputs
- Get resolution on issues affecting project deliverables
- Timely escalation of unresolved issues to internal & external (client) points of contact
- Perform project management activities involving internal and external communication, co-ordination, planning and meeting submission timelines
- Review & analyze aggregate safety data (line listings, summary tabulations, literature reports, etc.) to draw appropriate safety conclusions for assigned aggregate safety reports (PADERs, PSURs, PBRERs, CARs, DSURs, ACOs, ad hoc reports), CCDS supporting documents, RMPs, signal reports, clinical and integrated safety summaries, etc.
- Review and analyze safety data (index/ sentinel cases, case series, line listings & other relevant safety data) to identify safety signals, discuss findings with the Aggregate Safety Physicians
- Contribute to and lead strategy/ kick-off meetings (internal & with Client PoCs) for assigned reports
- Discuss safety analysis in meetings and advise designated safety writer in appropriate presentation of data, interpretation and safety conclusions in consultation with Aggregate Safety Physicians
- Take part in signal/ safety review meetings with Clients and help gather additional safety data for signal evaluation (SMQs, literature search strategies, external databases), conduct literature review and analysis of collated data
- Review assigned reports to ensure overall scientific quality of aggregate reports & provide constructive feedback
- Author signal reports (ad hoc & periodic) & safety issue analysis reports
- Author and/or review SOPs, WIs and other procedural documents or sections of these, as applicable
- Guide and mentor Safety Writers/Scientists in acquiring relevant knowledge and skills for aggregate data analyses
- Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
- Assist in estimation of resource requirement and responding to RFPs as needed
- Maintain project schedules, conduct regular status reviews to ensure project timeline compliance

**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.

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