Medical Reviewer

YOH Services LLC
United States, Massachusetts, Cambridge
Feb 22, 2025
Medical Reviewer Category: Life Science Employment Type: Contract Reference: BH-382714 Medical Reviewer Cambridge, MA (hybrid, 2 days per week onsite, Monday - Friday) 1 year contract Pay Rate: $140.00 - $142.34 Per Hour (depending on experience) *M.D. is required with experience in medical case review is must for this role Candidates do not need to be licensed in the U.S and no specialization is needed Required: Minimum of 1 year ARGUS and ISR review (individual case study reports)* Qualifications: The ideal candidate will have the following mix of personal and professional characteristics: Medical Degree with a minimum of 1 year of medical practice is required Must have a minimum of 2 years of pharmaceutical industry experience within pharmacovigilance or clinical research Experience in medical case review is a strong plus Sound clinical acumen and a wide range of therapeutic area knowledge. Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment Strong communications skills, both written and spoken, ideally with experience in medical / scientific writing Expertise in international regulations governing drug safety. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments highly preferred Experience in managing compliance or audits is a plus Ability to work in fast-paced environment with rapidly approaching timelines is important Summary: The Medical Reviewer role is to perform medical case review and to provide expertise on all aspects of it with emphasis on harmonization of medical review approach. This role will interface across all levels and functional areas of GPSRM and partner with the clinical development as well as Data Management teams. The exceptional candidate that we seek will have an excellent medical judgment, strong analytical skills, understanding of lifecycle of drug safety and a flexible, hands-on nature with a high sense of urgency. Summary of Key Responsibilities: Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process Collaborate with other pharmacovigilance colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues Identify topics for escalation and collaborate with safety product leads to investigate potential safety signals Collaborate with GPSRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of Head of Medical Review Participate in process improvements for the Medical Review team Maintain close communication with the case processing and medical case review vendors Other: There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth. This position offers an opportunity to have tremendous impact on the growth of the company. The culture values hard-work, creativity, flexibility, collaboration and a hands-on, problem-solving attitude. Estimated Min Rate: $140.00 Estimated Max Rate: $142.34 Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.