Safety Surveillance Associate

0-3 years

Not Disclosed

Chennai

10 March 2, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Surveillance Associate

Company: Pfizer

Location: Chennai, India

Employment Type: Full-Time (Hybrid)

About Pfizer:

At Pfizer, our Worldwide Medical and Safety team plays a critical role in supporting evidence-based medical decision-making. Whether it’s developing frameworks for scientifically robust evidence, providing unbiased medical expertise, or addressing data gaps, our mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

Position Purpose:

The Safety Surveillance Associate is responsible for the review, preparation, and completion of reports on adverse drug experiences, ensuring compliance with regulatory requirements and determining the safety profile of Pfizer’s products.

Reporting To:

Case Processing Team Lead

Key Responsibilities:

Identify and select routine cases for processing, determining prioritization criteria and documenting any delays.
Assess cases for complexity and specific issues, escalating appropriately.
Review, verify, and process case details, including:
- Event terms
- Case classifications (validity, seriousness, expectedness, etc.)
- Product complaint information
- Reportability with due dates
- Accuracy and consistency of information
Determine appropriate case workflow and write/edit case narratives.
Generate reports while ensuring adherence to regulatory compliance timelines.
Determine follow-up requirements, requesting follow-up letters as necessary.
Coordinate with Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders for safety data collection and reconciliation.
Develop expertise in Pfizer’s products, global regulations, SOPs, data conventions, and safety database functions.
Ensure consistent application of regulatory requirements and Pfizer policies.

Qualifications & Skills:

Education: Minimum Bachelor’s degree in a healthcare-related field (Pharmacy, Dentistry, Nursing, etc.).
Experience: 0–3 years in pharmacovigilance or related domains.
Strong analytical and problem-solving skills.
Excellent attention to detail and data management capabilities.
Ability to work in a fast-paced, regulatory-driven environment.

Work Arrangement:

Hybrid (Combination of office and remote work)

Why Join Pfizer?

Work with one of the world’s leading pharmaceutical companies.
Gain valuable experience in pharmacovigilance and regulatory compliance.
Opportunity for career growth in a globally recognized organization.
Pfizer is an equal opportunity employer, fostering an inclusive and diverse workplace.

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Safety Surveillance Associate

Job Description

About Pfizer:

Position Purpose:

Reporting To:

Key Responsibilities:

Qualifications & Skills:

Work Arrangement:

Why Join Pfizer?

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