Labcorp Drug Development- Apply for Junior Safety Data Analyst
Pune, India
About the job
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.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
Principal Responsibilities
Triage and classify ICSRs for report type, seriousness, causality, labeling and reporting; prioritize ICSR according to regulatory requirements
Completion of remaining case data entry, including narrative or auto- narrative
Completion of risk and quality (label, approval, and manual coding). Clarification of unclear or illegible information from the ICSR sender (i.e. local safety officer [LSO] or Call Center)
Liaise with appropriate stakeholders (e.g. Global Medical Safety Operations Physicians [GMSOP], LabCorp Pharmacovigilance Physicians [PVPs]) to clarify appropriate information required for case processing
Prioritization of incoming cases for daily workflow management Participation in assigned projects, including inspection/audit readiness activities and inspection and audits as identified, including interviews and provision of requested data
Other activities relating to case processing as appropriate per case, including but not limited to:
Single case unblinding, Serious Adverse Event (SAE) reconciliation, deviation memo preparation, deletion/ requests as needed
Mentoring/training new hires, if required
Responding to Client in a timely manner
Involve and support quality improvement trainings and initiatives.
Quality Review (as Applicable)
Perform Quality Review of ICSRs after the data entry. Participate in project teams to improve ICSR quality Document the quality review results and provide feedback to relevant team members
Identify trends in errors and help identify training needs Processes & Procedures
Comply with SOPs and Work Instructions (WI) Comply with Client guidance documents
Adhere with MedDRA coding dictionary and MedDRA Points to Consider
Understand relevant safety implications regarding contracts with operating companies and/or marketing partners
Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned products
Interested candidate can apply through below link ;
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