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:
