Safety Surveillance Associate @ Pfizer

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Safety Surveillance Associate

Pfizer
2 - 5 years
Chennai
4 days ago
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Job Description

About the job

Use Your Power for Purpose At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Organizational Relationship(s) including to whom the position reports to: Case Processing Team Lead 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) Minimum a bachelor s degree in healthcare professional qualification (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: Occupational Health & Safety
Role: Chief Safety Officer (CSO)
Employement Type: Full time

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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

Since its founding in 1910, Hitachi has responded to the expectations of society and its customers through technology and innovation. Our mission is to Contribute to society through the development of superior, original technology and products. Over the past 100+ years this commitment has led us to ...

Safety Surveillance Associate @ Pfizer

Home > Occupational Health & Safety