Mohammed Tousif
Senior Drug Safety/Compliance Expert: Safety operations at Merck|Automation|GenAI|Prompt Engineer|
- Role
- Senior Drug Safety Expert Regional Safety at Merck Group
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Mohammed Tousif
ICSR Compliance: submission, distribution, transmission timelines; deviation management; CAPA effectiveness Workforce Management: capacity planning, scheduling, onboarding, training, performance coaching Training & SOPs: curriculum design, competency tracking, SOP/WI authoring and updates Stakeholder Engagement: medical safety, clinical, regulatory/quality, vendors and affiliates Continuous Improvement: digitalization, automation pilots, root-cause analysis, Kaizen AI/Automation: project lead for AI/ML use cases and BOT implementation in PV operations Mailbox Operations: global safety mailbox triage optimization and automation Advance prompt engineer Newsletter designing
Experience
Senior Drug Safety Expert Regional Safety
Dec 2021 — Present
Lead capacity planning, work allocation, onboarding, and training; coach team to elevate performance. Run daily huddles and maintain dashboards; report monthly deliverables to senior management; track KPIs and support development plans. Lead transitions for new programs/regions, establishing reconciliation and quality monitoring. Own ICSR compliance to meet regulatory timelines (submission, distribution, transmission). Conduct RCAs for late submissions; define, implement, and track CAPAs and mitigations. Manage audits/inspections; perform RCAs and drive CAPAs to closure. Lead AI initiatives from use-case ideation through development, implementation, and deployment. Optimize global safety mailbox operations with automation to reduce waste and improve triage throughput. Execute database and BOT testing/UAT; provide findings and enhancement recommendations. Harmonize and standardize global ICSR reconciliation, quality monitoring, and PDCS processes; minimize waste and streamline workflows. Conduct reconciliation, quality monitoring, and spot checks on safety data. Oversee global and local PDCS programs and vendor performance for ICSR reconciliation/quality monitoring; assess risks and partner with program leads
Education
St. Joseph's PU college
Pre University
Government College of Pharmacy
B.Pharma
Gautham College of Pharmacy
M Pharma
Skills
- Microsoft Word
- Microsoft Office
- Sales
- Leadership
- Formulation Chemistry
- Management
- Research
- Powerpoint
- Microsoft Excel
- Phacovigilance
- Clinical Research
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