Job Description
The Safety Associate (Hybrid Germantown, MD) assists in the processing of Serious Adverse Events (SAE) and Adverse Drug Reactions (ADR) and performs medical coding under supervision of the Medical Monitor(s).
Responsibilities - Enter incoming safety events into related tracking systems and databases.
- Handle incoming safety-related reports from clinical trial sites.
- Process expedited/non-expedited safety events based on the Medical Monitor's evaluation in accordance with company's SOPs and other regulatory guidelines.
- Perform data reconciliation for ad hoc and annual safety reports.
- Write SAE narratives
- Organize, attend and take minutes of Safety Department meetings.
- Provide administrative/logistical support for the Safety Department.
- Perform medical coding based on MedDRA and WHO Drug dictionaries under supervision of the Study's assigned Medical Monitor(s).
- Other duties as assigned
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Qualifications - RN preferred. Bachelor's degree in scientific or medical curriculum, or equivalent professional experience.
- At least one year of clinical research and drug safety and pharmacovigilance experience
- Competent in the use of Microsoft Office software.
- Understanding of medical terminology.
- Ability to work effectively both independently and in a team environment.
- Strong problem solving and decision-making skills.
- Strong oral communication skills.
- Written communication abilities to include drafting of memos, formatting and taking minutes.
Salary Range: $65,000 - $70,000 USD
The total pay range takes into account a wide range of factors that are considered in making compensation decisions including, but not limited to, skills; experience and training; licensure and certifications; and other business and organizational needs. The disclosed pay range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At NSF, it is not typical for an individual to be hired at or near the top of the pay range for their role and compensation decisions are dependent on the facts and circumstances of each case.
About Us With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life.
One of our core values is We Are One NSF. This means that while we're one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work.
Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org.
NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.
About the Team From research to patient, NSF's expert team provides comprehensive regulatory, quality and clinical support to pharmaceutical, biotech, medical devices, in-vitro diagnostics, and combination products clients across the product life cycle to navigate complex regulations and industry challenges.
Job Tags
Full time, Work at office, Worldwide, Shift work,