Safety Writing Associate Ii

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. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

**Job Overview**:
Responsible for the preparation and review of parts of aggregate safety, risk management, and signal detection reports/activities, as assigned. Assist medical writers in data collection, strategy execution, and report content development. Prepare data summaries, literature abstracts, and other report components per specific requirements. Participate in the review process and provide inputs for resolving comments and finalizing report content. Support report management activities to ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

**Summary of Responsibilities**:

- Perform allied activities such as generation of outputs/reports from the databases or safety systems, distribution of data requests, sales data calculations, regulatory website searches, collating report planning materials, etc.
- Author full or 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.
- Develop the assigned report parts, examples of which may include sections with majorly pre-populated template text, re-use of content from other documents, or low to medium complexity of safety analyses. Review and annotate line listings, prepare case narratives or data summaries, and present data per approved strategy. Participate in comment resolution discussions for the assigned sections.
- Support medical writers in signal detection activities, including data cleaning, review and annotation of line listings, creating supporting material for signal review meetings, and preparing parts of signal reports.
- Support the preparation of ad hoc reports such as safety issue analysis reports, and justification/supporting documents for label updates.
- Write sections of Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
- Conduct literature searches for authoring various types of reports. Review the search outputs for selection of articles potentially relevant for inclusion in safety reports. Prepare abstracts or summaries of the selected articles.
- Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
- 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.

**Qualifications (Minimum Required)**:

- Minimum of first degree in life sciences (or equivalent).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

**Experience (Minimum Required)**:

- Excellent command of written and spoken English.
- Good written and verbal communication skills.
- Knowledge of MS Office.
- Good organizational and time management ability.
- Excellent interpersonal skills.
- Scientific or Clinical research experience desirable.
- Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

**Preferred Qualifications Include**:

- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- Preferably 2-year experience in the medical writing or Pharmaceutical Industry.

**Physical Demands/Work Environment**:

- Office environment or remote.

**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, ge