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Pfizer

Compare

4.0

based on 1.8k Reviews

Video summary

20 Pfizer Jobs

Sr. Associate - Safety Surveillance

PFIZER LIMITED

4.0

based on 1.8k Reviews

0-6 years

Chennai

1 vacancy

Sr. Associate - Safety Surveillance

Pfizer

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

Data Entry Pharmacy Pharmacovigilance Healthcare Medical Writing Data Collection

+ 3 more

Job Description

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s 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.
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.