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Safety Science Analyst

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Fortrea

Oct 14

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Pune
  • Quick Apply

AI generated summary

  • You should process adverse events, perform data entry, write narratives, assist in regulatory submissions, maintain documentation, and ensure compliance with safety reporting requirements.
  • You will intake and process safety reports, enter data, write narratives, submit regulatory documents, reconcile databases, ensure compliance, and assist with queries while maintaining documentation.

Requirements

  • Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial
  • Assist with processing of the adverse events, including but not limited to:
  • Data entry of safety data onto adverse event tracking systems
  • Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
  • Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
  • Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed
  • Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines
  • Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines
  • Assist in the reconciliation of databases, as applicable
  • Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
  • Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable
  • Support upload/archival of case/study/project documentation, as appropriate
  • Build and maintain good PSS relationships across functional units
  • Support compliance of operations with governing regulatory requirements
  • Any other duties as assigned by management

Responsibilities

  • Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial
  • Assist with processing of the adverse events, including but not limited to:
  • Data entry of safety data onto adverse event tracking systems
  • Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
  • Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
  • Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed
  • Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines
  • Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines
  • Assist in the reconciliation of databases, as applicable
  • Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
  • Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable
  • Support upload/archival of case/study/project documentation, as appropriate
  • Build and maintain good PSS relationships across functional units
  • Support compliance of operations with governing regulatory requirements
  • Any other duties as assigned by management

FAQs

What are the primary responsibilities of a Safety Science Analyst?

The primary responsibilities include performing case intake and triage of safety information, processing adverse events, data entry onto tracking systems, writing patient narratives, coding adverse events, assisting with report submissions to regulatory agencies, and maintaining documentation regarding adverse event reporting requirements.

What qualifications are needed for this position?

While specific qualifications are not listed in the job description, a background in safety science, pharmacovigilance, or a related field is typically required, along with knowledge of regulatory requirements and adverse event reporting.

Is there any travel involved in this role?

The job description does not explicitly mention travel requirements, but it may be necessary to attend meetings or conferences, as needed.

What software or systems will I be required to use?

The role involves data entry onto adverse event tracking systems and may also require familiarity with MedDRA for coding adverse events.

How does Fortrea ensure diversity and inclusion in the workplace?

Fortrea is committed to diversity and inclusion and does not tolerate harassment or discrimination. They base employment decisions on business needs and individual qualifications, encouraging all applicants regardless of legally protected characteristics.

Are there opportunities for career advancement in this position?

While the job description does not specify, positions in safety science analysis often provide opportunities for career growth within regulatory affairs, safety management, or other related fields in the pharmaceutical industry.

Can I apply if I have a disability?

Yes, Fortrea encourages all individuals, including those with disabilities, to apply, as they are an Equal Opportunity Employer.

What is the work environment like for this role?

The work environment is likely collaborative, involving interactions with various functional units and adherence to a Quality Management System framework.

What types of reports will I be handling as a Safety Science Analyst?

You will be processing and submitting expedited and periodic reports related to adverse events to clients, regulatory authorities, ethics committees, and other stakeholders.

Who will I work with in this role?

You will work closely with medical staff, regulatory authorities, and project personnel from Fortrea, among others, fostering good relationships across functional units.

Science & Healthcare
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.