Medical Reviewer
2 weeks ago
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Essential Functions -
Perform medical review of Individual Case Safety Reports (ICSRs) in accordance with ProPharma Standard Operating Procedures and Work Instructions. Determine event-level causality for applicable reports. Generate company comments for select reports. Serve as a case review resource for Pharmacovigilance staff as needed (e.g., seriousness assessment of ICSRs). Participate in the development of departmental policies and procedures and client-specific documents (e.g., Expected Terms List) as needed. Provide expert medical safety analysis for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, biologics, bridging reports, Signal reports, Health authority requests/queries, and other relevant aggregate reports. Provide medical safety expert opinion for the Signal detection process and risk management activities. Provide a medical review of scientific Literature articles/abstracts along with expert or company comment Must be able to assess and identify safety risks and potential signals in safety reports or from designated RSI of suspect products. Must be able to perform accurate labeling assessment wherever required for periodic safety reports. Must be able to handle all medical-relevant queries and address medical-related issues from health authority queries/Vendor queries related to aggregate reports or Signal detection reports. Must regularly Liaise with peer medical reviewers and also with vendor medical reviewers in assessing expert outcomes or opinions for all Safety reports. Providing oversight for overall Pharmacovigilance (PV) and medical affairs for relevant medical products. Must be able to take up any additional PV activities as delegated by the reporting manager relevant to the functionality of process or project at an organization Would be an active part of any vendor-related AUDITs, and safety committee meetings and be responsible for any medical review relevant activities. Should maintain all medical relevant trackers /Minutes of meetings/training records on a real-time basis. Provides training to pharmacovigilance associates or newly joined medical reviewers on medical-relevant topics, as and when required. Should be able to conduct medical-relevant knowledge sessions to the entire team as and when required on medical-relevant topics related to underlying indications or medical disorders in discussion.Education Required:
MBBS/MDExperience:
2+ Years of professional experience. Experience in ICSR Medical Review and Aggregate reports review (PSUR/PADER/PBERER/Signal Detection/RMP)We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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