Medical Reviewer/Safety Reviewer

Job Description

Job Description

Job Description :

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.  

• Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.

• Monitoring of safety-related queries to Investigators.

• Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision.

• Current with knowledge of ICH, FDA, and EMA regulatory guidance's affecting safety surveillance.

• Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.

• May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.

• Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.

• May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Qualification:

• Bachelor's degree with related health science background.

• RN or clinical pharmacy experience strongly preferred.

• A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.

• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.

• Ability to present accurate and medically sound safety data, both orally and in writing.

• Effective communication skills in delivering study-related information.

• Proficiency in Computers (Windows, Word, Excel).

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities