Mohammed Najeeulla Khan
Monmouth Junction,USA
Summary
- Thrive in a client-facing environment.
- Excellent communication (written and verbal) and interpersonal skills.
- Passion for transforming pharmacovigilance using emerging cognitive computing technologies.
- Passion for delivering innovative solutions for improved patient outcomes.
- Knowledge backed by experience in the life sciences industry.
- Excellent analytical abilities and problem-solving skills.
- A conscientious, detail-oriented nature.
- Proven experience as Communication, Change, Innovative Agent.
- Pharmaceutical/Biotechnology industry experience.
- Experience working in cross functional, multi-cultural and global environment.
Overview
20
20
years of professional experience
Work History
Medical Director, Safety Physician
Alfasigma (Intercept) Pharmaceuticals
Morristown, NJ
07.2023 - Current
- Provide medical interpretation of information from various sources to inform the safety profile of assigned products, such as clinical trial and postmarketing adverse events and safety information, nonclinical and toxicology information, scientific literature, and product quality complaints
- Perform medical review of individual adverse event reports both from clinical trials (SAEs and SUSARs) and post-marketing, for seriousness, expectedness, and causality, completion of Analysis of Similar Events for IND Safety Reports, and completion of Investigator Safety Letters
- Contributes to the strategic planning, coordination, review, and management of critical Safety documents (e.g., IND, NDA, sNDA, PBRER/PSUR, DSUR, Protocols, ICFs, IBs, clinical study reports, and other aggregate reports, regulatory updates, etc.)
- Supports the selection and oversight of CROs/vendors, including the use of associated metrics
- Works with staff to ensure appropriate scientific rigor in the analysis and interpretation of clinical trial and post marketing data to support patient safety, regulatory applications or business/marketing objectives
- Lead product benefit-risk assessment and presentation to the Safety Committee and any needed actions to update patient safety information.
- Provides Safety Evaluation and Risk Management safety expertise and support to externally facing groups and cross functional stakeholders
- Maintains close collaboration and cooperation with clinical operations on the implementation and execution of Medical Safety processes in clinical studies
- Effectively communicate and respond to product safety queries from all sources, including ethics committees and regulatory authorities.
- Provides mentoring and coaching to safety scientists and other SERM team members
- Provides support to safety governance bodies including GSC and works closely with SERM leadership to monitor safety governance processes and procedures
- Identifies significant issues that may impact overall project plans and initiate contingency and business continuity plans as appropriate
- Supports safety surveillance of global scientific literature.
- Lead and/or participate in the development and maintenance of risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), as needed.
- Own the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for developed products.
- Supports the enhancement of Standard Operating Procedures and Work Instructions in compliance with current regulations, and helps maintain audit and inspection readiness.
- Supports the maintenance of Safety Surveillance Plans.
- Operate and chair the safety committee (RMC, DMC, SMT, MSRC) throughout the lifecycle of the assigned products.
- Ensure routine signaling activities, assessments, and investigations are effectively completed and documented in a timely manner, and review signal evaluation reports.
- Responsible for management, training, and performance review of team of DSPs & DSS
- Drive the spirit of 'ONE Team' across all functions by supporting a team approach to focus on our patients as our top priority.
Director
ClinChoice Inc, K&L Inc
Fort Washington, PA
01.2022 - 06.2023
- Responsible for review of Individual Case Safety Reports (ICSRs). Ensures completeness and accuracy of safety information in ICSR through the assessment of seriousness, expectedness, causality, MedDRA coding, review of the narrative summary, and providing case comments; provides medical inquiries for follow-up.
- Provides oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trialsParticipate in individual project teams and provide medical input/expertise.
- Driving quality management, workload management, compliance management, and document management across assigned projects.
- Provide oversight in the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts, and other reports as necessary.
- Responsible for safety signal detection activities for assigned products and discuss safety signals as needed, at the Safety Review Team (SRT)
- Managing project and resource allocation, supervising 8 direct reports supporting safety projects
- Ensuring the delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating teams to ensure the efficient operation of the drug safety function.
- Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products
- Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans
- Medical Safety Lead for safety reports and strategic documents such as Health Hazard Evaluation reports, Signal evaluation reports, Proactive Safety reports
- Lead safety signal surveillance on an ongoing basis. Providing benefit-risk assessment on potential safety signals as needed
- Represent the Clinical and PV departments during for-cause or maintenance client audits, or regulatory authority inspections.
- Recommend changes and upgrades to existing departmental policies, SOPs, and systems to ensure global regulatory compliance.
- As a leader of people and teams, manage the team’s expectations and their growth within the organization
- Responsible for recruitment of new staff in Clinical and PV Department.
Associate Director
ClinChoice Inc, L Inc
Fort Washington, PA
01.2019 - 12.2021
- Provided leadership and assisted in collaborations with Clinical Development and Medical Affairs and applicable functional specialists
- Provided leadership and assisted in the preparation of expedited and aggregate safety reports (e.g.,15-day Alert Report, PBRER, Annual Safety Report)
- Provided support for the framework for safety surveillance activities, safety management team meeting for the assigned TA
- Directed the Safety Management Team for the assigned projects/product ensuring safety and risk/benefit
- Reviewed safety sections / safety deliverables to ensure consistency and compliance
- Detected, validated, and managed pre-and/or post-approval safety signals through resolution
- Validated and implemented upgrades to the safety database, in conjunction with ClinChoice IT department and the vendor
- Supported health authority inspection and drafted response to ad- hoc health authority queries
- Involved in weekly global literature review of databases for review of safety information and signal detection as a part of routine surveillance activities
- Managed delivery of all work streams through work stream managers ensuring timely delivery with highest quality
- Development and maintenance of updates to Product Surveillance Plans, Medical Monitoring Plans, Safety Management Plans, Safety Reporting Guideline documents & other safety documents
- Provide input to clinical sections of regulatory documents, including protocols, Investigator Brochures, ICF, DSURs, IND annual reports, and others as needed.
- Reviewed and analyzed data from clinical trials for the prompt identification of safety signals
- Reviewed and evaluated serious adverse event reports from clinical trials for completeness, accuracy, expectedness, and relatedness.
Senior Manager
FMD K&L Inc. / iMEDGlobal Corporation
, Pennsylvania
07.2014 - 12.2018
- Provided expertise and leadership for internal and client Medical Safety programs, centers, systems, and projects
- Serve as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studied
- Authored, reviewed, and approved regulatory documents such as PADERs, PSURs, PBRERs, ACO, CSR, REMS, and any other regulatory documents
- Evaluated potential or confirmed safety issues raised to the Safety Management Team from external and internal sources by any functional group (e.g., Q&C, R&D)
- Directed the development and implementation of strategies for risk management activities, as required after approval for marketing and for products under development.
- Providing inputs for CAPA management and Deviation Management
- Created and maintained SOPs & Working Instructions
- Participated in audits and inspections.
- SME support for new business opportunities, as needed.
Senior Medical Researcher
Deloitte
Bangalore
05.2013 - 05.2014
- Proactively and more accurately monitor product safety profile and understand causality by tracing data to real patients, significantly reducing risk
- Better understanding of treatment pathways, real world drug effect within targeted populations, and unmet medical need
- Assess and characterize signals through examination of competitive drugs, class effects
- Develop a comprehensive value-based care delivery product strategy that brings together comparative analytic, benchmarking, regulatory reporting, gold-standard clinical content and care management on a single platform
- Providing insights with the available clinical data for better health interventions
- Development and deployment of interactive health economic models to support decision.
Senior Drug Safety Physician
Accenture
Bangalore
05.2010 - 05.2013
- Managing team of drug safety physicians and scientist
- Work with the supervisor to escalate issues or tasks outside the normal scope of work
- Performed medical expert analysis and further processing of adverse events and SAE (Serious Adverse Events) from various sources on time, within given timeframe and based on company SOP
- Perform medical analysis for tracking safety database, assessing the medical coding relevant terminology using MedDRA, generating queries pertinent to the case, active involvement with quality control and assisting with SAE reconciliation
- Authoring and medical review of aggregate reports such as Periodic Safety Update Report (PSUR) / Periodic Benefit Risk Evaluation Report (PBRER)
- Participate in Signal Detection meetings, as requested by client
- Provide client with line listings and summary tabulations for each Signal Detection Request
- Review line listing of non-serious cases approved by Scientist
- Deviation Management and implementing Corrective and Preventive Action (CAPA).
Senior Medical Safety Specialist
Aditya Birla Minacs
Bangalore
01.2009 - 05.2010
- Organize and summarize medical record data such as medical diagnoses, operative procedures, therapies, prescriptions, and lab work from claims data
- Review, validate, and determine patterns in claim utilization history
- Review medical and/or pharmacy claims data to identify gaps in care compared to widely- accepted guidelines and standards of care
- Review claims summaries for documentation of age-appropriate preventive screenings and/or disease-specific testing.
Specialist Physician
Mallige Hospital
Bangalore
02.2005 - 04.2010
- Provided clinical care to ICU patients, monitored prognosis, and performed emergency medical procedures
- Set up patient charts and documented information in EHR
- Monitored patients with acute medical conditions for changes, improvements or need for intervention
- Diagnosed and treated patients with chronic and acute health problems, including MI, arrhythmias, asthma, COPD, pneumonia under supervision
- Diagnose patient, write case history, and treat the patient under the guidance of senior consultants
- Typing daily progress notes into EHR under supervision of senior physicians
- Entered patient insurance, demographic, and health information into EHR and confirmed records
- Evaluated nursing notes to confirm accuracy of described care provided and patient responses.
Medical Safety Specialist
Marlabs Pvt Ltd
Bangalore
04.2008 - 12.2009
- Review medical and/or pharmacy claims data to identify gaps in care compared to widely- accepted guidelines and standards of care
- Review claims summaries for documentation of age-appropriate preventive screenings and/or disease-specific testing
- Develop clinical educational materials, including member or physician letters
- Develop clinical rules for algorithms to help streamline identification of patients not meeting standard care guidelines
- Talent hiring, new hire training, and mentoring.
Medical Officer
Freedom Foundation
Bangalore
07.2006 - 04.2008
- Conduct day to day review of patients; monitor clinical course, disease progression and response to ART/ATT
- Perform diagnostic procedures like internal jugular catheterization, pleural tapping, ascitic tapping, and lumbar puncture
- Initiating and monitoring patients on anti-retroviral therapy
- Treatment of opportunistic infections such as tuberculosis, pneumocystis pneumonia, candidiasis
- Involved in comprehensive training programs in creating public awareness on various issues like general infectious diseases, Human Immunodeficiency Virus (HIV), and acquired immunodeficiency syndrome (AIDS)
- Conducting counselling session for HIV/AIDS patients.
Education
Advanced Physician Medical Monitor Certification (APMMC), CCRPS -
CCRPS
USA05.2009
Post Graduate Diploma - Maternal and Child Health (PGDMCH
Kempegowda Institute of Medical Science
Bangalore01.2009
Government Hospital Tumkur, TB Center
Hospital, Bangalore, India, Karnataka03.2005
Bachelor of Medicine and Bachelor of Surgery (M.B.B.S -
Sri Siddhartha Medical College
Tumkur01.2005
Skills
- Software Proficiencies
- Microsoft Office (particularly Excel, Word, PowerPoint, Visio, and MS Project),
- SharePoint, SAP Business Objects,
- ARISg, Argus, Emperica,
- TMF and EDC
- Veeva Vault
Timeline
Medical Director, Safety Physician
Alfasigma (Intercept) Pharmaceuticals
07.2023 - Current
Director
ClinChoice Inc, K&L Inc
01.2022 - 06.2023
Associate Director
ClinChoice Inc, L Inc
01.2019 - 12.2021
Senior Manager
FMD K&L Inc. / iMEDGlobal Corporation
07.2014 - 12.2018
Senior Medical Researcher
Deloitte
05.2013 - 05.2014
Senior Drug Safety Physician
Accenture
05.2010 - 05.2013
Senior Medical Safety Specialist
Aditya Birla Minacs
01.2009 - 05.2010
Medical Safety Specialist
Marlabs Pvt Ltd
04.2008 - 12.2009
Medical Officer
Freedom Foundation
07.2006 - 04.2008
Specialist Physician
Mallige Hospital
02.2005 - 04.2010
Advanced Physician Medical Monitor Certification (APMMC), CCRPS -
CCRPS
Post Graduate Diploma - Maternal and Child Health (PGDMCH
Kempegowda Institute of Medical Science
Government Hospital Tumkur, TB Center
Bachelor of Medicine and Bachelor of Surgery (M.B.B.S -
Sri Siddhartha Medical College