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Senior Safety Surve
Thepharmadaily
posted 2mon ago
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Key skills for the job
Job Description
- Identify and select routine cases for processing, establishing appropriate prioritization criteria and documenting reasons for any delays.
- Assess cases to identify complexities and escalate issues as necessary.
- Review, rank, verify, process, and document event terms, case classifications (validity, seriousness, expectedness / listedness / labeledness) , special scenarios, product complaint information, reportability with due dates, and ensure accuracy and consistency based on case assessments.
- Evaluate case criteria to determine the correct workflow for processing.
- Write and edit case narratives.
- Generate reports while adhering to regulatory compliance timelines.
- Determine appropriate case follow-up, including requesting follow-up letters when necessary.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and reconciliation.
- Develop and maintain expertise in all products within the Pfizer portfolio, as well as relevant corporate and global regulations, guidelines, Standard Operating Procedures, writing practices, data entry conventions, and database search functions.
- Consistently apply regulatory requirements and Pfizer policies.
Technical Skill Requirements:
- Experience in pharmacovigilance, clinical care, or clinical/scientific research is preferred but not mandatory.
- Strong computer literacy, especially in managing relational databases.
- Ability to achieve personal objectives while meeting departmental performance standards.
- Capability to work under supervision in a matrix organization.
- Excellent oral and written communication skills.
- Fluency in spoken and written English; knowledge of additional languages is an advantage.
- Experience and skills in medical writing are a plus.
Qualifications:
- Health Care Professional background (e.g., Pharmacy, Dentistry, Nursing).
- Pharmacovigilance or relevant experience: 0-6 years.
Employment Type: Full Time, Permanent
Functional Areas: Other
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