Safety Writer

3 weeks 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.

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables

Ensure compliance of operations with governing regulatory requirements

Create, maintain and assume accountability for a culture of high customer service

Efficiency in conducting literature searches for authoring various types of reports

Author/review various safety reports (or part of such reports) for global regulatory submissions for Fortrea’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.

Perform/review Signal detection activities

Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports

Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs

Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document

Author/review SOPs/WIs/process documents or sections as applicable

Impart/conduct Trainings for peers and team members

Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings

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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