Safety Data Management Specialist jobs in United States
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Pfizer · 3 months ago

Safety Data Management Specialist

Pfizer is a leading healthcare company focused on empowering healthcare decisions. The Safety Data Management Specialist will monitor drug, biologics, and medical devices surveillance programs, including the intake, evaluation, and processing of adverse reports, while supporting clinical trials and post-marketing activities.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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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

Qualification

PharmacovigilanceData ManagementMedical WritingHealthLife SciencesComputer LiteracyFluency in EnglishProblem SolvingDecision MakingTeam Collaboration

Required

Bachelor's Degree in Health or Life Sciences
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
Demonstrated computer literacy
Fluency in spoken and written English

Preferred

Health Care Professional or equivalent experience preferred
1+ years' experience in pharmacovigilance and/or data management preferred but not required
Experience and skill with medical writing an advantage
Experience in use and management of relational databases preferred

Benefits

Participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage

Company

Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.

Funding

Current Stage
Public Company
Total Funding
$38B
Key Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B

Leadership Team

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Albert Bourla
Chief Executive Officer
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Ian Read
Chief Executive Officer
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Company data provided by crunchbase