ABSALI SHAMSUDEEN
Manama,Bahrain
Summary
A highly motivated pharmacy graduate with overall experience of 15+ years which includes, substantial work experience in Clinical Research, Pharmacovigilance (drug safety) and pharmacist (dispensing & community pharmacy). Currently working as a Regulatory & Quality Control personnel in Anbu pharmacy WLL, Bahrain.
Overview
19
19
years of professional experience
Work History
Manager (Regulatory Affairs & Quality Control)
Anbu pharmacy WLL
, Bahrain
01.2025 - Current
- Respond to queries from medical bodies like the NHRA, SFDA, MoH and other applicable Health Authority. Monitor and set timelines for license variations and renewal approvals, work with specialist computer software and resources.
- Write clear, accessible product labels and patient information leaflets; plan and develop product trials and interpret trial data. Develop and implement procurement strategies for pharmaceutical products and materials; identify and evaluate potential suppliers and maintain strong relationships.
- Negotiate contracts, terms, and pricing with suppliers & manage inventory levels to ensure continuous supply without overstocking. Ensure all procurement activities comply with regulatory standards & monitor market trends and adjust procurement strategies accordingly.
- Collaborate with internal departments to understand procurement needs; prepare and present reports on procurement activities and cost savings.
Assistant Manager (Pharmacovigilance)
Tata Consultancy Services
Mumbai, India
10.2023 - 03.2026
- Understands applicable local, national, and regional regulations and translates them into organizational best practices. Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs.
- Reviews surveillance alerts and queries and determine actions to be taken through to implementation. Advises, consults, and makes final recommendations to all aspects of clinical regulatory intelligence. Makes recommendations in expertise to internal stakeholders.
Senior Pharmacist
Sri Raghava pharmacy
Chennai, India
12.2023 - 12.2024
- Verify the dosage and appropriateness of prescriptions, and prepare them according to the prescriber's instructions. Provide information and advice about medications.
- Organize the pharmacy to make it easier to identify products, and manage pharmacy staff, such as pharmacy techs and assistants.
- Maintaining records the records of patient history, medications, and other activities and comply with all applicable legal rules, regulations, and procedures.
Manager (PV Operations)
Parexel International
Mumbai, India
03.2023 - 11.2023
- Manage a team of safety officers and specialists to improve operational efficiency and compliance, handled 10 plus PV associates for daily smooth deliverable with less client escalations; provide guidance and expertise in safety operations to internal teams and stakeholders.
- Develop and maintain Pharmacovigilance safety monitoring systems to track safety trends. Review and analyze safety data to identify potential risks and implement corrective actions.
- Oversee Pharmacovigilance safety operations and ensure compliance with regulatory requirements.
Team Lead & Data Analyst (Pharmacovigilance)
Cognizant technology solutions
Mumbai, India
11.2012 - 10.2016
- Support roles involved in creation of Aggregate Safety Reports (ASRs), facilitate Aggregate Report production activities across organizations, participate in project teams and facilitate coordination of activities required to implement initiatives.
- Managed total of 10+ team members and achieved smooth deliverables with less client escalations. Ensure synchronization among ASRs as necessary, plan and coordinate time and resources needed for ASR creation.
Process Associate (Pharmacovigilance)
Accenture services (P) Limited
Chennai, India
04.2010 - 10.2012
- Authoring of various kind of aggregate reports like PADER, PSUR, and PBRER.
- Data collection, annotations, listing generations, data correctness confirmation, literature search and submission of aggregate reports. To perform peer review of reports and provide feedback on discrepancies.
- Prepare and tracking of aggregate reports calendar. Effectively execute SOPs, WIs, and other relevant standard procedures for delivering the daily routine tasks.
- Collaborate the drafting of key SOPs and WPs related to ASR processes; draft user guides for document management system; perform other activities as needs arise in the context of ASRs; assist with continuous improvement projects/updates.
Internship in clinical research
Translational Medicine India
Bengaluru, India
09.2008 - 03.2010
Training in Clinical Research
Meenakshi mission Hospital
Madurai, India
09.2007 - 09.2008
Education
Bachelor of Pharmacy -
J.S.S College of Pharmacy
Ooty, IndiaSkills
- Regulatory Affairs
- Pharmacovigilance
- Clinical Research
- Quality Management
Place
Manama, Bahrain
Cpr Number
841456178
Languages
- Tamil
- Hindi
- English
- Tamil
- Hindi
Roles And Responsibilities
Respond to queries from medical bodies like the NHRA, SFDA, MoH and other applicable Health Authority. Monitor and set timelines for license variations and renewal approvals, work with specialist computer software and resources., Write clear, accessible product labels and patient information leaflets; plan and develop product trials and interpret trial data. Develop and implement procurement strategies for pharmaceutical products and materials; identify and evaluate potential suppliers and maintain strong relationships., Negotiate contracts, terms, and pricing with suppliers & manage inventory levels to ensure continuous supply without overstocking. Ensure all procurement activities comply with regulatory standards & monitor market trends and adjust procurement strategies accordingly., Collaborate with internal departments to understand procurement needs; prepare and present reports on procurement activities and cost savings., Verify the dosage and appropriateness of prescriptions, and prepare them according to the prescriber's instructions. Provide information and advice about medications., Organize the pharmacy to make it easier to identify products, and manage pharmacy staff, such as pharmacy techs and assistants., Maintaining records the records of patient history, medications, and other activities and comply with all applicable legal rules, regulations, and procedures., Manage a team of safety officers and specialists to improve operational efficiency and compliance, handled 10 plus PV associates for daily smooth deliverable with less client escalations; provide guidance and expertise in safety operations to internal teams and stakeholders., Develop and maintain Pharmacovigilance safety monitoring systems to track safety trends. Review and analyze safety data to identify potential risks and implement corrective actions., Oversee Pharmacovigilance safety operations and ensure compliance with regulatory requirements., Understands applicable local, national, and regional regulations and translates them into organizational best practices. Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs., Reviews surveillance alerts and queries and determine actions to be taken through to implementation. Advises, consults, and makes final recommendations to all aspects of clinical regulatory intelligence. Makes recommendations in expertise to internal stakeholders., Support roles involved in creation of Aggregate Safety Reports (ASRs), facilitate Aggregate Report production activities across organizations, participate in project teams and facilitate coordination of activities required to implement initiatives., Managed total of 10+ team members and achieved smooth deliverables with less client escalations. Ensure synchronization among ASRs as necessary, plan and coordinate time and resources needed for ASR creation., Authoring of various kind of aggregate reports like PADER, PSUR, and PBRER., Data collection, annotations, listing generations, data correctness confirmation, literature search and submission of aggregate reports. To perform peer review of reports and provide feedback on discrepancies., Prepare and tracking of aggregate reports calendar. Effectively execute SOPs, WIs, and other relevant standard procedures for delivering the daily routine tasks., Collaborate the drafting of key SOPs and WPs related to ASR processes; draft user guides for document management system; perform other activities as needs arise in the context of ASRs; assist with continuous improvement projects/updates.
Personal Information
- Passport Number: T 5 5 3 0 2 9 6
- Date of Birth: 04/14/84
- Marital Status: Married
Languages
English
Advanced
C1
Tamil
Proficient
C2
Hindi
Intermediate
B1
Timeline
Manager (Regulatory Affairs & Quality Control)
Anbu pharmacy WLL
01.2025 - Current
Senior Pharmacist
Sri Raghava pharmacy
12.2023 - 12.2024
Assistant Manager (Pharmacovigilance)
Tata Consultancy Services
10.2023 - 03.2026
Manager (PV Operations)
Parexel International
03.2023 - 11.2023
Team Lead & Data Analyst (Pharmacovigilance)
Cognizant technology solutions
11.2012 - 10.2016
Process Associate (Pharmacovigilance)
Accenture services (P) Limited
04.2010 - 10.2012
Internship in clinical research
Translational Medicine India
09.2008 - 03.2010
Training in Clinical Research
Meenakshi mission Hospital
09.2007 - 09.2008
Bachelor of Pharmacy -
J.S.S College of Pharmacy