Clinical Risk Management Associate - I Assistant

Qualifications Education: Graduate degree in nursing health sciences pharmacology epidemiology public health or other relevant healthrelated fields. Advance degree like PharmD PHD MDs preferred. Experience: At least 3 years of experience in clinical pharmacological or related field of expertise. Excellent writing and communication skills are a must. Experience in data analysis or the interpretation of adverse experience information is a plus. Candidates will not be seeing the patients. The candidates would not be required to have an active license. Must have: Previous experience in CROs /academia would be good Industry experience is preferred. Aggregate review of adverse events reports. Review of Individual case safety reports (ICSR). Review of adverse event narratives. Review of social medial post containing adverse events. Therapeutic Areas: Oncology general medicine. But other Therapeutic Areas experience is fine as well. Candidate will be responsible for the Safety & Risk Management for Developmental and Marketed Products. Software: MS office suite Veeva(SOPs) RXlogix (PV signals platforms) Important Notes: 100% remote. Positions available 3 Assignment could be extended beyond 6 months.
Responsibilities Performs primary medical review of serious adverse experience (AE) reports and other AE reports of interest in order to monitor and describe the safety profile of assigned products. Takes an active role in the oversight and development of pharmacovigilance and risk management plans (RMPs) of assigned products in collaboration with the CSRM physician. Prepares responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned products and in collaboration with the CSRM physician strategizes with the Risk Management Safety Team (RMST) recommending appropriate data to respond to queries and analyze data. Primary Activities Primary activities include but are not limited to: Applies clinical pharmacological and epidemiologic knowledge and information technology (IT) skills in order to manage the safety surveillance and risk management of assigned products in collaboration with the CSRM physician. In collaboration with the CSRM physician accountable for monitoring the overall safety profile of assigned products and for describing the safety profile to ensure external communications regarding the safety of these products are accurate. Performs safety surveillance review of adverse experience reports for assigned products which includes reviewing individual AE reports aggregate safety data published literature and information from external databases. Works with CSRM physician and scientist if applicable to select and analyze the appropriate data from available IT systems in order to investigate safety issues. Prepares responses to safety inquiries from health care professionals regulatory agencies subsidiary staff and other internal customers. Demonstrates a working knowledge of pharmacovigilance and risk management; may educate stakeholders outside of CSRM about risk management and the role of CSRM. Prepares summaries and analyses of safety related data for regulatory documents such as Periodic Safety Update Reports (PSURs) Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings. Interview:
Comments/Special InstructionsSr. CSP Vidushi Sharma. Submit your best 3 qualified candidates. Day to Day: Perform Safety Analysis for Clinical and post Marketing Data. Good Writing Skills. Candidate may be working with 7 to 8 colleagues on a program or project. Very collaborative environment. Working close with Physicians and other groups like Clinical & Regulatory in a very busy space. Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products. Taking an active role in the oversight and development of pharmacovigilance and risk management plans with direction/guidance from the CSRM team Assists the CSRM team to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck products. Strategizes with safety team recommending appropriate data to respond to queries and analyze data.
System Location: Research Labs (Z011) Required
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CWR Type: W2 Required