Safety Data Management Specialist

USA - Exception - Professional - USD (Contract)

Parsippany-Troy Hills, NJ, United States (On-site)

Contract (1 year 1 day)

Published 4 days ago

safety database

Adverse Drug Events

Drug Safety

Safety Data Management Specialist

Reports to Country Safety Lead or Safety Team Lead or Safety Officer

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports.

Primary Responsibilities

• Carry out case processing activities.
• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments.
• Review case criteria to determine appropriate workflow for case processing.
• Assess cases to distinguish those with particular complexities and/or specific issues and elevate appropriately.
• Write and edit case narrative.
• Determine and perform appropriate case follow-up, including generation of follow-up requests.
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
• Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation.
• Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database.
• Determine reportability of scheduled reports, ensuring adherence to regulatory requirements.
• Consistently apply regulatory requirements and Pfizer policies.
• Participate, as appropriate, in local, internal, and external safety activities.

Technical Skill Requirements

• Experience in pharmacovigilance and/or data management preferred but not required.
• Experience and skill with medical writing an advantage.
• Demonstrated computer literacy.
• Experience in use and management of relational databases preferred.

Qualifications (i.e., preferred education, experience, attributes)

• Health Care Professional or equivalent experience preferred.
• Bachelor's degree in science discipline
• Ability, with supervision, to solve routine problems and to surface issues constructively.
• Ability to make basic decisions with an understanding of the consequences.
• Ability to achieve personal objectives while meeting departmental standards of performance.
• Ability to work under supervision in a matrix organization.
• Fluency in spoken and written English.

Pay Rate Range

• Min Pay Rate $35
• Max Pay Rate $40
• Currency USD
• Unit hourly

Additional Notes

Please note that contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.

Benefits Information

• Comprehensive Benefits Package available based on eligibility
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Supplemental and Voluntary Life Insurance