Pfizer – Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That’s why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.
We are recruiting to fill the position below:
Job Title: Safety Data Management Specialist
Job Requisition ID: 4936190
Location: Lagos
Employment Type: Full Time (Hybrid)
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.
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 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
- Review case criteria to determine the appropriate workflow for case processing.
- Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.
- Write and edit a case narrative.
- Determine and perform appropriate case follow-up, including generation of follow-up requests.
Qualifications (i.e., preferred education, experience, attributes)
- Health Care Professional or equivalent experience preferred.
- Ability to achieve personal objectives while meeting departmental standards of performance.
- Ability to work under supervision in a matrix organisation.
- Fluency in spoken and written English.
- Ability, with supervision, to solve routine problems and to surface issues constructively.
- Ability to make basic decisions with an understanding of the consequences.
Technical Skill Requirements:
- Experience in pharmacovigilance and/or data management preferred but not required.
- Experience in the use and management of relational databases is preferred.
- Experience and skill with medical writing are an advantage
- Demonstrated computer literacy.
How to Apply
Interested and qualified candidates should:
Click here to apply
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