Safety Data Management Specialist

Job Title: Safety Data Management Specialist Location: Parsippany-Troy Hills, NJ Type: Contract Compensation: $38 an hour W2 Contractor Work Model: Onsite Job Name: Safety Data Management Specialist Location: Parsippany, NJ Contractor Work Model: Onsite Full Job Description: 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 escalate 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 Notes from MSP: Candidate will be: Trained extensively through online modules and instructor-led training Working directly with the hiring manager and another team lead Supported by onsite mentors (team onsite on a rotating 2.5?day schedule but support always available) # of openings: 1 Contract Length: 12 months System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- #DI- Ref: #568-Clinical