Associate – Safety Data Management Specialist (Chennai)

Associate – Safety Data Management Specialist (Chennai)

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.
Primary Responsibilities




Carry out case processing activities
Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
Review case criteria to determine appropriate workflow for case processing
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Write and edit case narrative
Determine and perform appropriate case follow-up, including generation of follow-up requests
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
Determine reportability of scheduled reports,



ensuring adherence to regulatory requirements
Consistently apply regulatory requirements and Pfizer policies
Participate, as appropriate, in local, internal and external safety activities
Here Is What You Need (Minimum Requirements):
Education = B. Pharm, M. Pharm, or Pharm. D only.
Minimum experience = 1 year. Maximum = 2 years.
Knowledge of ICSR processing.
Ability to work collaboratively in a team environment.
Bonus Points If You Have (Preferred Requirements):
Hands on experience in ARGUS safety database.
Proficiency with processing source documents in XML format (E2B R2 and R3).
Valuable knowledge of medical terminology and global regulatory requirements for drug safety.
Work Location Assignment: Hybrid





Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical]]>

📌 Associate – Safety Data Management Specialist (Chennai)
🏢 Pfizer
📍 Chennai