Safety Writing Assistant Ii

**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 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 several 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.
- And all other duties as needed or assigned.

**Qualifications (Minimum Required)**:

- Minimum of first degree in life sciences (or equivalent).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- At least 6 months or a year's experience in the pharmaceutical industry.

**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 guideline.

**Preferred Qualifications Include**:

- Advanced degree (e.g., PhD or Masters) preferred.

**Physical Demands/Work Environment**:

- Available for travel 5% of the time, including overnight stays as necessary consistent with project needs and office location.

Learn more about our EEO & Accommodations request here.