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Pharmacovigilance Scientist II at Global Pharma Tek LLC

Pharmacovigilance Scientist II

Global Pharma Tek LLC Raritan, NJ Full-Time
 Job Description
The Sr. Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). The Sr. Scientist will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents.  The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.
Principal Responsibilities:
List major responsibilities and duties of the position, including delegated duties. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position's major responsibilities or end results.
Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development
Initiate/Conduct/Oversee searches of internal and external databases
Perform and/or lead aggregate safety analysis and case level review
Author, contribute, and coordinate the preparation of core safety deliverables
Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
Partner with vendor to develop reports/deliverables
Provide SMT support as needed
Act as ad hoc member for assigned products as appropriate
Training/Meetings/Department initiatives
Participate in cross-functional training of relevant stakeholders
Attend departmental meetings and trainings
Participate in department and/or cross-functional initiatives
Working Relationships/Interfaces: 
Global Medical Safety Operations (GMSO) is a functional area within Global Medical Organization (GMO)
Will work in a matrix environment interface with the following functions as needed to complete deliverables:
TA Safety Head
Medical Safety Officer (MSO)/designee
Compound Development Team members
Medical Safety Surveillance and Insight Physicians and Staff
Management and Scientists, Global Case Management
Epidemiology Staff
Compliance, Standards and Analytics (CSA) group
Regulatory Affairs Associates, Managers and Directors
Clinical and Medical Affairs individuals and organizations (e.g., our financial client, GMARCC, GCO)
Safety Data Analytics (SDA)/Client Support Desk Staff
Local Safety Officers
Client International Pharmacovigilance (IPV) Regional Heads
GMO Senior Leadership Team
Office of the QPPV
Regulatory Medical Writing Personnel
Vendor Management
Education & experience requirements:
Bachelor's Degree in Health or Biomedical Science (6-8 years  industry experience or equivalent)
Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)
Clinical/Medical writing or PV experience preferred
Strong English verbal and written communication skills

Recommended Skills

  • Case Management
  • Clinical Works
  • Communication
  • Data Analysis
  • Databases
  • English
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Job ID: 20-00008

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