Pfizer, a global leader in pharmaceuticals, is offering an exciting career opportunity for individuals aspiring to work in the field of drug safety and pharmacovigilance. The position of Safety Surveillance Associate in Chennai provides a platform for healthcare professionals to contribute significantly to ensuring the safe and effective use of medicines.
Safety Surveillance Associate
Location: India – Chennai
Job Time: Full Time
Job ID: 4932230
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).
0–3-years’ experience in pharmacovigilance/ related domains.
Work Location Assignment: Hybrid
This opportunity at Pfizer Chennai is ideal for professionals looking to start or advance their careers in drug safety. If you have the required qualifications and a passion for ensuring drug efficacy and patient safety, this could be the perfect role for you.