Associate – Safety Data Management Specialist
IND - Chennai Office, India
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.
- End to End ICSR processing, including listedness assessment.
- 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).
- Good knowledge of medical terminology and global regulatory requirements for drug safety.
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#LI-PFE* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Job stats:
0
0
0
Tags: Data management XML
Region:
Asia/Pacific
Country:
India
More jobs like this
Explore more career opportunities
Find even more open roles below ordered by popularity of job title or skills/products/technologies used.
Power BI Developer jobsBusiness Intelligence Developer jobsPrincipal Data Engineer jobsBI Developer jobsStaff Data Scientist jobsStaff Machine Learning Engineer jobsPrincipal Software Engineer jobsJunior Data Analyst jobsData Science Intern jobsDevOps Engineer jobsData Manager jobsData Science Manager jobsSoftware Engineer II jobsAccount Executive jobsStaff Software Engineer jobsData Analyst Intern jobsLead Data Analyst jobsBusiness Data Analyst jobsAI/ML Engineer jobsSr. Data Scientist jobsData Specialist jobsData Governance Analyst jobsSenior Backend Engineer jobsData Engineer III jobsBusiness Intelligence Analyst jobs
Consulting jobsMLOps jobsAirflow jobsOpen Source jobsEconomics jobsLinux jobsKPIs jobsKafka jobsTerraform jobsGitHub jobsJavaScript jobsPostgreSQL jobsRDBMS jobsData Warehousing jobsNoSQL jobsClassification jobsBanking jobsStreaming jobsScikit-learn jobsPrompt engineering jobsRAG jobsComputer Vision jobsPhysics jobsGoogle Cloud jobsPandas jobs
Hadoop jobsOracle jobsScala jobsdbt jobsBigQuery jobsLooker jobsReact jobsGPT jobsData warehouse jobsR&D jobsLangChain jobsScrum jobsPySpark jobsDistributed Systems jobsMicroservices jobsCX jobsELT jobsIndustrial jobsSAS jobsOpenAI jobsJira jobsRedshift jobsModel training jobsTypeScript jobsJenkins jobs