Medical Reviewer/Safety Reviewer II

Location: REMOTE, Massachusetts

Category: Medical Affairs

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description Target PR Range: 24-34/hr

• Depending one experience

Ob 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.

Experience/Skills 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).

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. Off-label information would be disseminated at this level. 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.

• CO/NYC candidates might not be considered

Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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