Experience

• 

  Al-Madina Pharmaceuticals Ltd.

  • Bangladesh
  • Pharmaceutical Manufacturing
  • 1 - 100 Employee

  • Deputy Manager

    • Jun 2021 - Present

  • Assistant Manager, Regulatory Affairs and Marketing Services; Focal Point, Pharmacovigilance

    • Oct 2018 - Feb 2022

    Drug Regulatory Affairs Responsibilities:1. Submission of new medicines, and line extensions dossiers according health authority requirements, timeous registration and products launches in line with business requirements in Bangladesh and export markets.2. Pharmaceutical change control (dossier maintenance) for registered medicine to ensure regulatory compliance.3. Providing regulatory input to product management teams and approving promotional materials.4. Prepare and Implement of Standard Operational Procedures (SOP) related to Product Registration, Renewal, and Amendment Documents submission to regulatory authority.5. Training of new colleagues of Regulatory Affairs and Quality Assurance in SOP and compliance matters – interactions with healthcare professionals, promotional materials, and medicines legislation.Pharmacovigilance Responsibilities:1. Collection and submission of Adverse Events/Special Scenario reports to local health authority according to deadlines.2. Follow-up attempts: relevant information through active contact with consumers and HealthcareProfessionals.3. Providing of Medical/Scientific/Technical information to internal and external customers of Al-Madina Products.4. Training of Al-Madina group staff on adverse event reporting responsibilities as well as orientatingthem on the Medical Information functions.5. Establishment and maintenance of processes and databases for storing, archiving and retrievingmedical information and drug safety documents.6. Preparing and Implement of Standard Operational Procedures (SOP) related to Pharmacovigilance.Marketing Services Responsibilities:1. Prepare training manual and model detail talk for field colleagues. 2. Train up all field colleagues.3. Attain monthly meeting in different region of Al-Madina market.

• 

  Novo Healthcare and Pharma Ltd.

  • Plot # 2, Road # 11, Block # C Section # 6 , Mirpur Dhaka-1216, Bangladesh

  • Senior Executive, Regulatory Affairs, MSD ; and Focal Point, Pharmacovigilance

    • Jul 2017 - Sep 2018
    • Plot # 2, Road # 11, Block # C Section # 6 , Mirpur Dhaka-1216, Bangladesh

    Drug Regulatory Affairs Responsibilities:1. Submission of new medicines, and line extensions dossiers according health authority requirements, timeous registration and products launches in line with business requirements in Bangladesh and export markets.2. Pharmaceutical change control (dossier maintenance) for registered medicine to ensure regulatory compliance.3. Providing regulatory input to product management teams and approving promotional materials.4. Prepare and Implement of Standard Operational Procedures (SOP) related to Product Registration, Renewal, and Amendment Documents submission to regulatory authority.5. Training of new colleagues of Regulatory Affairs and Quality Assurance in SOP and compliancematters – interactions with healthcare professionals, promotional materials, and medicines legislation.Pharmacovigilance Responsibilities:1. Collection and submission of Adverse Events/Special Scenario reports to local health authority according to deadlines.2. Follow-up attempts: relevant information through active contact with consumers and HealthcareProfessionals.3. Providing of Medical/Scientific/Technical information to internal and external customers of Al- Madina Products.4. Training of Novo staff on adverse event reporting responsibilities as well as orientatingthem on the Medical Information functions.5. Establishment and maintenance of processes and databases for storing, archiving and retrievingmedical information and drug safety documents.6. Preparing and Implement of Standard Operational Procedures (SOP) related to Pharmacovigilance.

• 

  Cosmic Pharma Ltd.

  • House#-20, Road# 6 Rupnagar, Dhaka 1216, Bangladesh

  • Executive, Regulatory Affairs & Product Management

    • May 2015 - Jun 2017
    • House#-20, Road# 6 Rupnagar, Dhaka 1216, Bangladesh

    Major Responsibilities:1. Submission of new medicines, and line extensions dossiers according health authority requirements, timeous registration and products launches in line with business requirements in Bangladesh and export markets.2. Pharmaceutical change control (dossier maintenance) for registered medicine to ensure regulatory compliance.3. Providing regulatory input to product management teams and approving promotional materials.4. Product launching plan in details and searching new molecules.5. Developing & designing various Packaging and printed promo materials.6. Preparing product wise-monthly, quarterly and yearly marketing and sales planning & forecast.7. Train up all field colleague about Product knowledge, Physiology, Pharmacology, Microbiology,Biochemistry, and Marketing & Sales.

• 

  Qucare & Co.(Consultant of Sanofi Bangladesh Ltd., Elanco Bangladesh Ltd.,and other Pharmaceuticals)

  • 56, West Panthopath, Dhaka-1205, Bangladesh

  • Executive, Regulatory Affairs and Business Development

    • Sep 2012 - Apr 2015
    • 56, West Panthopath, Dhaka-1205, Bangladesh

    Responsibilities:1. Assist to provide consultancy on Marketing, Sales, Distribution and Manufacturing for pharmaceuticals Ltd.2. Assist to train up Marketing and Sales Professional of National and Multinational Pharmaceuticals Company of the Country.3. Assist in market analysis of Pharmaceuticals Ltd.4. Provide DRA service to Leading National and multinational Pharmaceuticals Company.

• 

  Management Sciences for Health

  • House-3, Road#23, Gulshan 1, Dhaka-1212, Bangladesh

  • Associate, Pharmacovigilance

    • Jun 2012 - Aug 2012
    • House-3, Road#23, Gulshan 1, Dhaka-1212, Bangladesh

    Responsibilities:1. Assessment of Regulatory and Pharmacovigilance System in Bangladesh.