Saddam Shaikh
Pharmacovigilance officer | SME | literature | Regulatory compliance | ARGUS database | Regulatory submission
- Role
- Drug Safety Associate 2 at Indegene
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Saddam Shaikh
As a Pharmacovigilance Subject Matter Expert specializing in literature case processing…
Experience
Drug Safety Associate 2
Oct 2023 — Present · Bangalore, IN
Overview:As a Pharmacovigilance Subject Matter Expert (SME) specializing in Literature Case Processing, I ensure the accuracy and quality of literature cases. My role encompasses case processing, conducting peer Quality Control (QC) reviews, and facilitating sessions on error resolution.Key Responsibilities:Literature Case Processing:Analyze and process literature cases accurately, ensuring all relevant data is extracted and recorded according to regulatory standards.Peer Quality Control (QC):Conduct thorough QC checks on processed literature cases to verify data accuracy and consistency.Provide constructive feedback to peers, promoting continuous improvement and adherence to quality standards.Training and Development:Lead training sessions and workshops on error resolution and best practices in literature case processing.Develop training materials to support ongoing education and skill development within the team.Error Resolution:Identify common errors in literature case processing and develop strategies for prevention and resolution.Serve as a resource for team members, offering guidance on complex case issues.Collaboration and Communication:Work closely with cross-functional teams to integrate literature data into broader case processing workflows.Communicate QC findings and recommend improvements to stakeholders.Skills and Competencies:Attention to detail and exceptional analytical skills.Strong verbal and written communication abilities.Proactive problem-solving and collaboration skills.In-depth knowledge of industry regulations and standards.Achievements:Implemented a peer QC program, reducing error rates by XX%.Led training sessions that significantly improved team efficiency and accuracy.Developed an error resolution guide adopted department-wide.
Education
Ingenious healthcare
Advance certification in Pharmacovigilance and clinical trials , Pharmacovigilance and clinical trials
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, Computer and Information Sciences and Support Services
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