LabCorp Freshers D Pharma Job Opening – Safety Science Specialist
Labcorp Senior Safety Science Specialist vacancy. D Pharma job opening 2021, Pharma specialist job opening at Lapcorp. Candidates with a diploma degree in pharma may apply for the job opening. Interested and eligible candidates may apply and check out all the details on the same below:
Job Title: Senior Safety Science Specialist
Location Bangalore, India
Job ID: 69199
Eligibility Criteria:
PharmD + 0 yrs relevant experience
BS/BA + 1-2 yrs relevant experience**
MS/MA + 0 yr relevant experience**
- Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
- Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
- Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
Job Overview:
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- entry of safety data onto adverse event database(s) and tracking systems
review of adverse events for completeness, accuracy, and appropriateness for expedited reporting - write patient narratives
- code adverse events accurately using MedDRA determine expectedness/listed news against appropriate label identifies clinically significant information missing from initial reports and ensures its collection ensure case receives appropriate medical review
prepare follow-up correspondence consulting the medical staff accordingly. - ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, and Labcorp project personnel, if required, within study specified timelines
- Maintain a strong understanding of Labcorp’s safety database conventions or client-specific database conventions, as appropriate.
- Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
- Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
- Assist in the preparation of listings for Annual IND reports Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
- Work with Data Management or client on reconciliation of safety databases.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Maintains a comprehensive understanding of Labcorp’s Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs, and safety processing guidelines set forth by the departmental management team and the client.
- Build and maintain good PV&DSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company values on a consistent basis.
- Begin to develop a good knowledge of contract assumptions; identifying out-of-scope work.
- Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Begin participating in Labcorp’s project teams and client meetings as appropriate. Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities, or clients.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Assist in the coordination of endpoint committees, as required.
- Any other duties as assigned by management.
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