Clinical Risk Management Associate I (100% Remote)

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:

Position Title: Clinical Risk Management I

Position Type:  Full Time / Contract
Job Location: North Wales, PA
Compensation: $69.25 per hour
Length of Assignment: 6 months with a possibility of extension
 
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 our client’s products.
• Strategizes with safety team recommending appropriate data to respond to queries and analyze data.

 

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.
• 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.

 
Qualifications:

• Graduate degree in nursing, health sciences, pharmacology, epidemiology, public health, or other relevant health-related fields.
• Advance degree like Pharm-D, PHD, MD's -preferred
• 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.
• MS Office Suite: Veeva (SOPs), RXlogix (PV signals platforms)

 
Apply Today!

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including:  Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

JD# 24-02636
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