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Senior Safety Surveillance Associate
Pfizer
posted 3mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Primary responsibilities:
- 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)
- Should be Health Care Professional (i.e, Pharmacy, Dentistry, Nursing.. etc).
- Pharmacovigilance or relevant experience: 0-6 years.
Work Location Assignment: Flexible
Employment Type: Full Time, Permanent
Functional Areas: Pharma/Healthcare
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Flexible timing
Monday to Friday
Within city
Day Shift
Pfizer Benefits
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Pfizer Chennai Office Location
Chennai Office
'B' Block, First Floor, Sunny Side, Door No.8/17 ,Shafee Mohammed Road, Nungambakkam,
Chennai
600 034
600 034
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