Safety Surveillance Associate @ Pfizer

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Safety Surveillance Associate

Pfizer
1 - 3 years
Chennai
2 months ago
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Job Description

Position Purpose:

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.

Qualifications (i. e. , preferred education, experience, attributes):
Masters degree in healthcare profession (ie, Pharmacy, Dentistry, Nursing etc).
1-3-years experience in pharmacovigilance/ related domains.

Work Location Assignment: Hybrid

Medical

#LI-PFE

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Environment Health & Safety
Role Category: Community Health & Safety
Role: EHS Officer
Employement Type: Full time

Contact Details:

Company: Pfizer
Location(s): Chennai

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Keyskills: Nursing Pharmacy Standard operating procedures clinical development Data collection Healthcare Workflow Pharmacovigilance Case processing Data entry

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Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Pfizer

â€œSone Indiaâ€ was conceived in the year 2014, the new millennium and since then has been one of the most successful and fastest growing electronic companies in India. The group comprises of multiple businesses providing end-to-end electronic solutions from design to manufacturing to distr...

Safety Surveillance Associate @ Pfizer

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