MOHAMMED TAQUIUDDIN
Deputy Manager/ Senior Safety Specialist
Hyderabad
Summary
Knowledgeable Safety Specialist with overall more than 14 years of working experience with 2 years in sales and 12 years in pharmacovigilance which includes case processing, PSUR, signal reports and RMP.
Overview
14
14
years of professional experience
Work History
Senior Drug Safety Specialist/ Deputy Manager
Viatris Inc
5 2017 - Current
- Complete authoring of Periodic Safety Update Reports (PSUR) and Addendum to Clinical overview (ACO) as per requirement
- Preparation of response to health authority queries
- Authoring aggregate data review reports for detection of new signals
- Authoring signal validation and assessment report which includes cases review, literature review and HA websites screening
- Authoring reports for review of Indeterminate Signals and Safety Topics under Close Monitoring
- Collaborating with other cross functional departments to get data for completion of reports
- Creation and maintenance of Non Innovator RSIs for generic products of Viatris
- Contribute towards coordination and execution of RMP project activities.
Pharmacovigilance Associate
ISafety Systems (formerly known as Medhimalayas solutions)
04.2014 - 05.2017
- Complete processing of case in ARGUS database
- Using of MedDRA and WHO Drug dictionaries appropriately for coding during processing of cases
- Picking up the case after data entry step and analyzing the case and making required changes to the case and routing it to next level for reporting
- To be compliant with all training requirements and to meet all SLAs
- Performing quality review of serious and non serious cases processed by other associates and routing the case to next level of reporting
- Writing pharmacovigilance comment for the case and assessing company causality
- Writing signal detection documents
- Analyzing and segregating data from generated line listings
- Analyzing and documenting data with a special emphasis on unlisted events above threshold limit and listed events for which there is a considerable increase in frequency during covering period
- Assessing various causal factors and documenting it in signal reports
- Searching different health authority websites for new information
- Authoring entire signal detection document and forwarding it for medical review
- Performing literature search in PUBMED and picking up new information from articles and incorporating in report
Drug Safety Associate
QUINTILES TECHNOLOGIES
12.2012 - 02.2014
- Initial receipt, registry, triage of incoming cases to determine seriousness for prioritization of daily workflow Database searches as necessary
- Perform adequate duplicate search in data base before creating and processing a case in SCEPTRE database
- Clarification of unclear or illegible information from the Local Safety Officer or call Centre and customer communication as per project requirement
- Discuss source documents, coding conventions and queries with Medical Assessment Physician
- Coding of medical history and adverse events by MedDRA
- Coding of suspect and concomitant medications by WHO dictionary
- Completion of literature searches as necessary
- Ensure accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality
- Writing medical narrative
- Complete processing and reporting of non-serious cases after proper quality check and routing serious cases to next level for reporting
- Other case processing related activities (e.g: review of consistency checks).
Professional Service Officer (PSO)
Pfizer India limited
10.2010 - 11.2012
- Promote research products of Pfizer to health care professionals
- Achieve monthly and yearly sales targets
- Use scientific literatures and study evidences in promoting of products.
Skills
PSUR
ACO
Signal detection
Medical writing
Aggregate reporting
Risk Management plan
Experience highlights
Aggregate reporting:
- Complete authoring of Periodic Safety Update Reports (PSUR) and Addendum to Clinical overview (ACO) as per the requirement.
- Authoring aggregate data review reports for detection of new signals
- Authoring signal validation and assessment report which includes cases review, literature review and HA websites screening.
- Authoring reports for review of Indeterminate Signals and Safety Topics under Close Monitoring.
- Drafting responses to health authority queries for PSURs
- Collaborating with other cross functional departments for completion of reports.
- Performing RMP project related activities such as collecting data on implementation of risk minimization measures
- Authoring Risk minimization evaluation reports
Education details
- Bachelor's degree in Pharmacy from MESCO College of pharmacy affiliated to OSMANIA University (2006 to 2010).
- Intermediate from Gowtham Junior College affiliated to Board of Intermediate Education AP.
- Schooling from Bharathi Vidhya Bhavan High School, Hyderabad, AP.
Disclaimer
I hereby declare that information furnished above is true to the best of my knowledge.
Timeline
Pharmacovigilance Associate
ISafety Systems (formerly known as Medhimalayas solutions)
04.2014 - 05.2017
Drug Safety Associate
QUINTILES TECHNOLOGIES
12.2012 - 02.2014
Professional Service Officer (PSO)
Pfizer India limited
10.2010 - 11.2012
Senior Drug Safety Specialist/ Deputy Manager
Viatris Inc
5 2017 - Current
Similar Profiles
Karthik BKarthik B
Senior Executive at Viatris IncSenior Executive at Viatris Inc
Sara Mohamed MahmoudSara Mohamed Mahmoud
Pharmaceutical Intern at ViatrisPharmaceutical Intern at Viatris
Jordan AubeleJordan Aubele
GSOC Analyst at QCIC/ViatrisGSOC Analyst at QCIC/Viatris
V V V SATYA NAVEENV V V SATYA NAVEEN
SAP Basis Consultant at Tata Consultancy ServicesSAP Basis Consultant at Tata Consultancy Services
Suresh BhumireddySuresh Bhumireddy
Technical Specialist at Bosch Global Software TechnologiesTechnical Specialist at Bosch Global Software Technologies