| Candidate Information | | Name | Available: Register for Free | | Title | Pharmacovigilance Services Sr Manager/ Medical reviewer lead | | Target Location | US-NJ-East Hanover |
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Click here or scroll down to respond to this candidateCandidate's Name
WORK EXPERIENCEAccenture (CRO for Alexion/AstraZeneca), Florham Park, NJPharmacovigilance Services Sr Manager/ Medical reviewer lead Jan 2021- CurrentDemonstrated exceptional leadership and personnel management skills in alignment with corporate management standards and policies.Oversaw all Pharmacovigilance (PV) operational and case management activities for safety reporting, including the collection, processing, and reporting/submission of safety information for all products (investigational and commercial).Reviewed and monitored case quality and compliance through various monitoring reports and other oversight activities.Provided direction and guidance to a team of medical review physicians, ensuring the highest level of case quality and global regulatory compliance. Served as a subject matter expert for a team of physicians supporting the Individual Case Safety Report (ICSR) medical review process.Conducted medical review of Individual Case Safety Reports (ICSRs) of clinical trial (phase I-IV) and post marketing. Identified cases meeting Investigational New Drug (IND) reporting criteria. Prepared IND narratives and performed risk assessments.Collaborated with internal teams to prepare for regulatory authority inspections and participated as a subject matter expert in relevant internal/external audits related to pharmacovigilance operations.Provided medical safety input and reviewed or drafted sections of response documents for health authority inquiries.Generated performance and compliance metrics and monitored for trends or areas for improvement.Led and provided safety operations support for assigned studies.Maintained a comprehensive understanding of ARGUS database conventions and system functionality.Participated in the development and maintenance of Pharmacovigilance (PV) System policies, Standard Operating Procedures (SOPs), forms, and guidance documents to ensure compliance with regulatory requirements, Good Pharmacovigilance Practices (GVP), and industry best practices.Collaborated with medical affairs, commercial, or marketing teams to develop processes, forms, and training materials to support patient support programs, market research, and investigator-initiated studies.Supported signal management activities, including signal investigations and drafting signaling reports.Collaborated on the preparation of aggregate safety reports such as Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), and Periodic Benefit-Risk Evaluation Reports (PBRERs). This included project management, data requests, qualitative and quantitative data analysis, data interpretation, narrative writing, and quality checks.Supported updates to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS) reports, as well as other assigned responsibilities.Trained new employees on pharmacovigilance and regulatory reporting.Eisai, Woodcliff Lake, NJProduct Safety Specialist Jan 2019- Jan 2021Performed medical review of ICSRs from clinical trial (phase I-IV) and post marketing.Evaluate safety data from multiple sources and assess clinical importance.Provide medical and scientific expertise to global cross-functional teams.Maintain knowledge of good clinical practices and pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.Meet deadlines and effectively handle multiple priorities.Maintain ability to see the context of the entire situation, understand implications to the business, think strategically, maintain global mindset, and big picture orientation.Work in/maintain complete understanding of ARISg database conventions and system functionality.Maintain the timely submission of expedited reports.Identify cases that meet IND reporting criteria, prepared the IND narrative, and perform risk assessment.Train new employees overall in pharmacovigilance and regulatory reporting.Provide appropriate and relevant input into project management.Liaise with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate.Abbvie, Lake Bluff, ILSenior Medical Safety analyst Jan 2017-Jan 2019Collaborate with the medical safety scientist to develop the report strategy and advise on the analysis.Train new employees overall in pharmacovigilance and regulatory reporting.Provide appropriate and relevant input into project management.Liaise with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate.Provide input for study specific system builds (EDC, IRT, ePRO etc.) for phase I-IV clinical trials.Provide input in study start up meetings, protocol build meeting and PST meetings.Provide other medical safety input as appropriate to Clinical Development Teams.Provide input for aggregate reports (PBRER, DSUR, PADER) and safety queries as needed.As appropriate, provided medical safety input, and review or draft sections of response documents for health authority inquiries.Work in/maintain complete understanding of ARISg database conventions and system functionality.Maintain the timely submission of expedited reports.Identify cases that meet SUSAR reporting criteria, prepared the SUSAR narrative, perform risk assessment.Various HospitalsClinical Rotation/ Medical fellowship January 2013-March 2015Responsible for diagnosis and treatment of patients under supervising physicians.Rotated in various fields of medicine (Internal medicine, Family medicine, Surgery, Nephrology, Radiology, Psychiatry etc.)Participated in daily rounds while assisting supervising physicians.Provided personalized health care services to ensure patient satisfaction and well-being.EDUCATIONMD, American University of Antigua College of Medicine, board eligibleo(United States Medical Licensing Examinations 1, 2, 3 & Educational Commission for Foreign Medical Graduates certified) |
