Safety Data Management Specialist
You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It
Contribute to completion of project milestones and organize own work to meet project task deadlines.
Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.
Support Worldwide Strategy and Regulatory teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
Review case criteria to determine the appropriate workflow for case processing.
Position Title: Safety Data Management Specialist (SDMS)
Reports to Country Safety Lead
Position purpose: 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..
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
Health Care Professional or equivalent experience preferred
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
Apply for the Job