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1 Pfizer Associate Job
Sr. Associate - Safety Surveillance
Pfizer
posted 5mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.
- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
- Review case criteria to determine the appropriate workflow for case processing.
- Write and edit the case narrative.
- Generate reports, ensuring adherence to regulatory compliance timelines.
- Determine appropriate case follow-up, requesting follow-up letters when appropriate.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
- Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
- Consistently apply regulatory requirements and Pfizer policies. Technical Skill Requirements
- Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
- Demonstrated computer literacy, particularly in the use and management of relational databases.
- Ability to achieve personal objectives while meeting departmental standards of performance.
- Ability to work under supervision in a matrix organization.
- Excellent oral and written communication skills.
- Fluency in spoken and written English; knowledge of additional language(s) an advantage.
- Experience and skill with medical writing an advantage.Qualifications (i. e. , preferred education, experience, attributes) .
- Minimum a Bachelor s degree in pharmacy, dental science, or equivalent; healthcare professional qualification is mandatory.
- 0-6 years of experience in Pharmacovigilance.
Employment Type: Full Time, Permanent
Functional Areas: Pharma/Healthcare
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What Associate at Pfizer are saying
Rating based on 19 Associate
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Anonymous · Production, Manufacturing & Engineering
in Visakhapatnam
Good work life balance
- Work-life balance - Good
No job security
- Salary - Poor
Associate salary at Pfizer
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