inVentiv Health 0000101300-Pharmacovigilance Scientist II in New Jersey

City:

State:NJ

Min Salary:$0.00

Max Salary:$0.00

Job Description:

Job Description for Contractors:

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 (eg, 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+ years 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 guidance related to post-marketing aggregate safety requirements

• Experience using Microsoft word templates

For further details or to apply for this job, please contact:jobs@inventivhealth.com

inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.