Associate Safety Scientist
Savient Pharmaceuticals, Inc. - Bridgewater, NJ

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Job Description The Associate Safety Scientist will be responsible for assisting in the preparation of periodic safety reports, including PSURs, PADERs and DSURs, for assigned Savient products. The Associate Safety Scientist will collaborate closely with Director, Pharmacovigilance on product safety teams and supporting risk management activities, including signal detection and tracking, Regulatory Authority requests and maintenance of Risk Management plans.

Essential Duties and Responsibilities
  • Coordinate preparation of aggregate safety reports (PSURs, DSURs, PADERs), including establishment of timelines, content and project management, safety database report requests, review of data/information and compilation of information
  • Participate on Disease-area Safety Team preparation and conduct, including signal detection/tracking, dRMP and RMP maintenance and other DST Risk Management activities
  • Liaising with Regulatory Affairs to coordinate synchronization and submission of periodic reports
  • Liaise with Quality, Standards & Training to ensure aggregate report procedures, training and activities are sufficiently defined and maintained.
  • Participate in departmental development activities including SOP and Work Instructions development, Audits and Inspections.
Clients
  • Project Lead
  • CRO Project Manager
  • External Service Providers (e.g., central labs, patient recruitment services, etc.)
  • Project Physician, Administrative Assistant
Clinical Operations Group
  • Publications/Regulatory Lead
  • Medical Affairs group

Qualifications Education Requirements
  • 4 year degree in Life science or related field
  • RN, Pharmacist or other healthcare professional or advance degree preferred
  • Ability to thrive in a fast-paced environment handling multiple simultaneous high priority tasks
  • Excellent verbal and written skills
  • Ability to interact and communicate effectively internally and cross-functionally
Experience Requirements
  • Minimum of 1-3 years pharmacovigilance experience, including aggregate/periodic safety report preparation, data analysis and medical/scientific writing
  • Direct applied knowledge of industry practices of product safety, risk management, product development
  • Knowledge and experience with clinical trial and post-marketing regulations and requirements

Additional Information Savient believes that benefits are an essential component of an employee's compensation package. Our benefits package is designed to deliver competitive, valuable options to our employees. Savients benefits package includes:
  • Medical
  • Vision
  • Life and AD&D Insurance
  • Long Term Care Plan
  • Flexible Spending Account
  • Employee Stock Purchase Plan
  • Competitive Vacation Policy
  • Tuition Reimbursement
  • Dental
  • Employee Assistance Program (EAP)
  • Short- and long-term Disability Insurance
  • Travel Accident Insurance
  • 401K Plan
  • Voluntary Life Insurance
  • Employee Referral Program

Savient Pharmaceuticals, Inc. - 21 months ago - save job