other
Posted May 8Lead Safety Science Specialist
at Fortrea
Bangalore, IndiaOn-site
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Responsibilities
- Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
- Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines.
- Perform peer/independent QC of Safety reports as needed.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
- Support audit or inspection preparations.
- Demonstrate role-specific Competencies and company values on a consistent basis.
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable).
Requirements
- Maintain a strong understanding of Fortrea’ s safety database conventions or client-specific database conventions, as appropriate.
- Maintains a comprehensive understanding of Fortrea PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance.
- Qualifications (Minimum Required): Non-degree + 2-3 years of Safety
- experience or 5 years of relevant experience. Associate degree + 2-3 years of Safety
- experience or 2-3 years relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience.
- Experience (Minimum Required): Good verbal and written communication skills and good presentation skills.
- Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct them.