Safety Surveillance Associate
Year Chennai, Tamil Nadu, India
Job Description
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Organizational Relationship(s) including to whom the position reports (JD Job Title):
Case Processing Team Lead
Position Purpose
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer\xe2\x80\x99s products and to meet regulatory requirements. -
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.
- Qualification:
- Bachelor\'s Degree in pharmacy, dental sciences or equivalent; healthcare professional qualification is mandatory.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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Job Detail
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Job IdJD3241161
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationChennai, Tamil Nadu, India
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EducationNot mentioned
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ExperienceYear