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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