Pharmacovigilance Scientist II

Title: Pharmacovigilance Scientist II

Duration: 4 Months

Location: Skillman, NJ, United States

Responsibilities

Brief Summary

The Sr. Scientist role is primarily responsible for the writing and review of safety supporting documents to support labelling changes/the development of new core safety information. He/she will contribute or will be responsible for report writing and/or report ownership related to safety supporting documents.

Daily activities involve database searching, aggregate safety analysis and case level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents. The Sr. Scientist will partner with team members, stakeholders such as safety physicians, and a vendor. The Sr. Scientist must be able to work on multiple projects simultaneously and prioritize tasks.

Responsibilities

• Sr. Scientist would be responsible to contribute to or serve as report owner for supporting documents for safety-related labeling information.
• The candidate will ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate
• Develop report strategy with stakeholders
• Initiate/conduct searches of internal and external databases
• Perform aggregate safety analysis and case level review
• Perform literature searches and identify/analyze relevant publications
• Present results to safety physician or cross-functional team
• Author/contribute to the preparation of safety supporting documents
• Partner with vendor to develop safety supporting documents/deliverables
• Comply with processes and ensure appropriate documentation
• Utilize technical skills and programs to analyze and organize data (e.g., Excel pivot tables, SAS JMP)
• Adhere to report timelines and escalate issues to management as appropriate

Qualifications/Experience Required

• Bachelor’s degree in health or biomedical science (6+ years industry experience or equivalent) or
• Advanced degree preferred in health or biomedical science (4+ year’s industry experience or equivalent)
• Clinical/medical writing and/or PV experience
• Aggregate safety report writing and aggregate safety analysis
• Knowledge of MedDRA hierarchy
• Searching and analysis of the literature
• Strong English verbal and written communication skills

Strongly Preferred

• Project management of safety/regulatory documents
• Awareness of applicable regulations and guidances related to post-marketing aggregate safety requirements
• Experience using Microsoft word templates

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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