Fasiuddin Mohammed
Patient Safety Specialist @Paraxel International India Pvt Ltd
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WORK HISTORY
Patient Safety Specialist @Paraxel International India Pvt Ltd
Hyderabad, IN
Jan 2021 – PresentProcess and quality-review high-volume ICSR cases with 99%+ accuracy, ensuring compliance with global regulatory timelines and client SOPs.Apply MedDRA coding with precision, aligning with “Points to Consider” guidelines to improve case consistency and medical accuracy.Maintain strong knowledge of assigned product safety profiles, contributing to error-free documentation and safety assessments.Support audit and inspection readiness, preparing evidence, addressing findings, and strengthening CAPA effectiveness.Conduct late case investigations, identify assignable causes, and implement corrective actions to improve reporting compliance.Coordinate translation requests and manage process-related user queries, improving workflow clarity and turnaround times.Mentor and train new joiners, helping boost team productivity and reduce onboarding time.Perform quality control checks on ICSR submissions, reducing recurrent data issues and improving overall case quality.Analyze PV metrics to track reporting performance and support continuous process improvements.Contribute to risk management plans (RMPs) and additional risk minimization activities to enhance product safety oversight.Manage safety mailboxes and communication workflows, ensuring timely triage and case initiation.
EDUCATION
Malla Reddy College of Pharmacy (MRCP), Secunderabad
Doctor of Pharmacy - PharmD, Pharmacy
Carmel Jyothi High School
High School Diploma
Malla Reddy College of Pharmacy (MRCP), Secunderabad
Doctor of Pharmacy, Pharmacy, Pharmaceutical Sciences, and Administration
Sri Gayatri Engineers
High School Diploma
ABOUT FASIUDDIN MOHAMMED
I’m a Patient Safety Specialist at Parexel with 6+ years of experience ensuring high-quality, compliant, and accurate drug safety reporting. My core strengths lie in ICSR case processing, MedDRA coding, quality review, and navigating global regulatory requirements with precision.I’ve worked across Argus, ArisG, and global PV workflows—supporting audits, CAPA, RMP activities, and mentoring new team members. I’m also passionate about using AI tools to boost efficiency and reduce errors across safety operations.What drives me is simple: delivering reliable safety insights that protect patients and strengthen decision-making.If you’re exploring opportunities or collaborations in pharmacovigilance, patient safety, or drug safety operations, let’s connect.
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