Safety Writing Assistant I
1 month ago
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.
Perform allied activities such as generation of line listings and summary tabulation, retrieval of data from safety tracking systems, preparation of call for information/contribution, drafting meeting minutes, maintenance of report trackers, mailboxes, etc.
Support Author for individual case narratives or summaries for adverse drug reactions and serious adverse events.
Compile or support experienced writers in preparations of parts of various safety reports for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned.
Perform any additional activities, as needed, to meet project requirement, per the manager’s discretion on completion of relevant training.
Implement the 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.
**Qualifications**:
Bachelor’s/Master’s degree in Pharmacy/related science area OR Bachelor’s degree in Medical Science
Experience
Fresher or minimum 06 months’ experience in the pharmaceutical industry.
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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