“Join Pfizer as a Safety Data Management Specialist!”

  • Full Time
  • Chennai

Website Pfizer

About Pfizer

Pfizer is a renowned global biopharmaceutical company known for its research, development, and production of prescription medicines for treating various diseases in humans and animals. Additionally, Pfizer collaborates with healthcare providers, governments, and communities worldwide to improve access to healthcare and support better quality health systems.

Post: Associate – Safety Data Management Specialist

Job Description:

Carrying out Case Processing Activities:

  • Reviewing, ranking, verifying, processing, and documenting case-related information such as event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency.
  • Processing cases based on comprehensive assessments.

Determining Appropriate Workflow:

  • Reviewing case criteria to determine the suitable workflow for case processing.
  • Assessing cases to identify complexities or specific issues and escalating them appropriately.

Case Narrative Management:

  • Writing and editing case narratives to ensure accuracy and completeness.
  • Performing appropriate follow-up actions for cases, including generating follow-up requests.

Quality Assurance and Compliance:

  • Reviewing processed cases to verify accuracy, consistency, and compliance with process requirements.
  • Ensuring adherence to regulatory requirements and Pfizer policies consistently.

Stakeholder Liaison:

  • Collaborating with key partners locally and other stakeholders regarding safety data collection and reconciliation.

Continuous Development:

  • Developing and maintaining expertise in corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and safety database functions.

Regulatory Reporting:

  • Determining the reportability of scheduled reports and ensuring compliance with regulatory requirements.

Participation in Safety Activities:

  • Participating in local, internal, and external safety activities as required.

Candidate Profile:

  • B. Pharm./ M.Pharm. / Pharm D graduates with 2-3 years of experience in ICSR case processing.
  • Demonstrates meticulous attention to detail and accuracy.
  • Possesses strong written communication skills.
  • Exhibits analytical and problem-solving skills.
  • Proficient in medical terminology.
  • Knowledgeable about ICSR processing guidelines, regulations, and event assessment.
  • Experience working with ARGUS database is preferred.

Additional Information:

To apply for this job please visit pfizer.wd1.myworkdayjobs.com.