Clinical Safety Scientist

**Job Description**:
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.

Key Responsibilities:

- Intake of reportable safety event information from clinical trial investigator sites
- Review, manage and create individual case safety reports for each event
- Ensure that all information required for a clinically complete and accurate case is present
- Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness
- Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes
- May collaborate with cross-functional colleagues as needed

Qualifications & Skills
- Basic understanding of scientific and medical concepts
- Basic understanding of drug development
- Basic knowledge of GCP and ICH regulations98
- Ability to work as part of a cross-functional team
- Ability to identify and escalate problems and contribute to issue resolution
- Time management and organizational skills
- Strong communication skills with advanced oral and written English skills
- Advanced computer, database skills

Education Requirement:

- M.D. with minimum 1 year of clinical work experience in a patient care setting or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.

Preferred:

- Experience in patient care setting, drug safety and pharmaceutical drug development

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are **

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for **

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
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**Requisition ID**:R237471