Job Description
Job Description The Medical Monitor/ Safety Data Analyst processes Adverse Event (AE) and Serious Adverse Event (SAE) cases promptly and with medical accuracy. The Medical Monitor/ Safety Data Analyst will also assist the Head of Safety and Pharmacovigilance Department with Medical Coding and Medical Monitoring activities and oversees the overall conduct of pre- and post-marketing studies regarding safety of the subjects for his/her studies, and as a back-up for other Medical Monitors.
Responsibilities - Oversee the overall conduct of pre- and post-marketing studies regarding Safety of study subjects for the assigned studies.
- Perform medical review of Protocols, Investigator's Brochures, Case Report Forms, Informed Consent forms, and Clinical Study Reports according to the Scope of Work
- Have a good understanding of all projects related to Safety and Coding.
- Interacts with Sponsors/Clients directly with minimal or no supervision for the assigned studies and other projects, as needed.
- Direct assigned Safety designees of each assigned projects with regard to Safety and Coding activities.
- Develop Pharmacovigilance, Safety Management and Medical Monitoring Plans
- Lead coding procedures of medical data including medications (utilizing WHODrug), adverse events and serious adverse events (utilizing MedDRA)
- Prepare safety case reports to the FDA and regional regulatory agencies using MedWatch and CIOMS-I forms, and annual/ periodic safety reports.
- Oversee Processing, Documentation, and Reporting of Adverse Event and Serious Adverse Event Information to the Client, and the FDA
- Prepare safety narratives
- Maintain, review, and reconcile safety and clinical databases for paper-based studies
- Evaluate safety trends, and pharmacovigilance risk assessment in collaboration with the biometrics department according to the Scope of Work.
- Assure that the required study documents are complete, accurate, and in accordance with required global and region-specific regulations and guidelines
- Participate in sponsor audits as required
- Participate in Bid Defense meetings.
- Provide support for the audits of clinical sites according to the Scope of Work.
- Participate in project team meetings as required
- Participate in Data Safety Monitoring Committees (DSMC), provide and present safety and pharmacovigilance reports for the DSMC meetings for various sponsors, as applicable
- Communicate orally and /or in writing, in a timely and effective manner, with the appropriate internal or external individuals involved in the project, including serving as the Medical Point of Contact for Investigator, and Sponsor teams.
#LI-SV1
Qualifications - Medical Degree required (e.g., M.D./D.O.)
- Knowledge of global and region-specific regulations and guidelines including ICH, US and EU, UK regulations.
- Knowledge of Adverse Event processing environments such as ArisGlobal or similar is preferred.
- Exceptional and effective verbal and written communication skills to facilitate and complete concise safety reporting.
- Experience with Safety audits of clinical trials is preferred
- Experience with Electronic Data Capture system (EDC)
- Ability to work in a fast-paced environment, handling multiple projects with high degree of accuracy and attention to detail.
- Basic understanding of clinical bio-statistical analysis, and the ability to think critically, analyze data, and problem solve.
- Ability to work independently as well as in a team environment contributing to a collaborative work atmosphere.
- Experience in communicating with Regulatory Agencies, Data Safety Monitoring Committees (DSMC), Sponsors, and Principal Investigators is preferred.
- Experience working with MedDRA and WHODrug dictionaries is preferred.
- Proficient in the use of Microsoft Office Software.
Salary Range: $102,00 - $133,000 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
Work at office, Worldwide, Shift work,