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Safety Science Coordinator Ii

3 months ago

Pune, Maharashtra, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.


  • Data entry of safety data on to 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.
  • Support and/or participate in audits and inspections including the preparation, as needed.
  • Determine listedness against appropriate label (for Marketed products, if applicable)
  • Identifies clinically significant information missing from the reports and ensures its collection; Prepare followup correspondence in consultation with the medical staff, as needed.
  • Perform any other support activities as assigned tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
  • Reconciliation of Safety information with; SDEA partners; managing timelines of reconciliation
Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea 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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