Safety Surveillance Associate

1 day ago

Chennai Tamil Nadu, India Pfizer Full time

Organizational Relationship(s) including to whom the position reports: 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.
- Technical Skill Requirements:

- Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
- Demonstrated computer literacy, particularly in the use and management of relational databases.
- Ability to achieve personal objectives while meeting departmental standards of performance.
- Ability to work under supervision in a matrix organization.
- Excellent oral and written communication skills.
- Fluency in spoken and written English; knowledge of additional language(s) an advantage.
- Experience and skill with medical writing an advantage.
- Qualifications (i.e., preferred education, experience, attributes):

- 0-4 year's experience in Pharmacovigilance/ Clinical research/ Hospital practice / Teaching etc.
- Mandatory of minimum bachelor’s in health care degree (ie, dentistry, pharmacy, nursing, or equivalent).

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.

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