Temp Mgr Global Patient Safety Sciences- Warren, Cambridge, Tarrytown or STRONG REMOTE EST

Orbis Clinical is seeking a Temp Manager, Global Patient Safety Sciences located in Tarrytown, NJ

Job Title: Temp Mgr Global Patient Safety Sciences

Location: Hybrid (Tarrytown, NJ) a minimum of 3-4 days ONSITE per week

Contract: 6months up to 24months

Summary:

The Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

Job Responsibilities:

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned molecules compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross-functional teams, including Company Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to the company.
• Experience in data manipulation and visualization (Excel, PIVOT tables, etc) for safety analysis
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Education

• Master of science degree, PhD, or PharmD.

Experience

• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority
• Clinical experience and/or Industry experience in the TA of interest is a plus

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $75.00 - $90.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group 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, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.