Sadia Moazam

• Company Overview: REMIT is a five-year (2021-25) technical assistance program in Pakistan funded by the Foreign, Commonwealth & Development Office (FCDO), UK
• Task Assigned to Devise a Policy 2023 for the Government for special Sectors by identifying revenue contributions, areas of hurdles/ development and advise to invest to make it more effective in future
• Thorough study of sectors along with its previous policies
• Coordination with IT /Communication , Pharma Industry, DRAP, Chemical Industry to identify issues
• Multiple Meeting with PM office & associated persons
• Devised a Policy outline for Pharmaceutical, Chemical & IT sectors
• Presented Policy points to the Adviser to Prime Minister for special Task
• REMIT is a five-year (2021-25) technical assistance program in Pakistan funded by the Foreign, Commonwealth & Development Office (FCDO), UK

• Coordination with Provincial & Federal Health Departments
• Support, Approvals & coordination with NIH & DRAP for Local Manufacturing of Covid 19 vaccine (First ever in Pakistan)
• Trainings on Pharmacovigilance
• Coordination with Chinese and Other companies for relevant areas of study and new drugs
• Market analysis/ Medical need for new drugs

• Covid 19 Vaccine emergency approvals, Govt
• Program implementation and monitoring
• Support, Approvals & coordination with NIH & DRAP for Local Manufacturing of Covid 19 vaccine (First ever in Pakistan)
• Monitoring and Country coordinator of CanSino Covid-19 Trial operations centers in Pakistan
• Established medical and regulatory Department
• Formation of Compliance standards and SOP’s with trainings
• Pharmacovigilance reporting system implementation as per local regulations & trainings
• Hiring and trainings of Sales and Regulatory Teams
• Developed company image by enhancing relationship with Health Department including Sec
• Health, Directors and CEO of DRAP

• Court Matters Including Drug Courts & High Courts
• Pharmaceutical Pricing cases & litigations
• Appearances before various Forum/Boards (Federal & Provincial Quality Control Boards) in matters pertaining to judicial or quasi-judicial proceedings
• Review of pharmaceutical both legal and technical agreements
• Advice, consultation and opinion work etc., cover all such matters as do not require any appearance before any Forum/Board and Court
• Advice on all matters pertaining to the Drug Act and all other relevant stated laws/ rules and all issues arising there from
• Advice on new notifications, circulars, policies and decisions made by different relevant boards of DRAP or any other concerned authority / courts on regular basis

• Key Contributor in developing “First National Medicine Policy” , Ministry of Health, Islamabad
• Smooth Transfer of Manufacturing Site & Divestment of Products
• CTD Trainer for WHO & DRAP organized program
• Managing other countries i.e., Afghanistan, Sri Lanka and Nepal
• Managed safety reporting activities including single case approval, monthly line listing review, quarterly signal identification, literature and publications review to monitor safety reporting for regulatory compliance
• Developed & implemented monitoring plans to evade counterfeit drugs
• Prepared and compiled aggregate safety periodic reports and safety risk management documents
• Successful completion of Regional project
• “Regulatory Environmental scan of Asia Pacific Countries”
• Successfully attained desired pricing of key top revenue generating products on hardship grounds
• Approval of Drug Manufacturing License, GMP, Sales Licenses & Dedicated Manufacturing Areas.(Dry Powder, Psychotropic)
• Representation at various boards, meetings & negotiations with Authorities
• Barcoding Implementation first time in Pakistan
• Developed and implemented pre and post-approval product-specific risk management plans based on product benefit-risk assessment
• Registration of WHO recommended Anti TB drugs
• Numerous line extensions, generics and NCE registrations by having robust strategy
• Psychotropic Registrations in Afghanistan in a lead time
• Afghanistan & Srilanka Registrations & compliance activities

• Company Overview: Pharma Bureau is an advocacy body representing country’s 23 leading multinational pharmaceutical research & biotechnology companies
• Working closely with members of Pharma Bureau and OICCI
• Policy Development and consultancy to DRAP
• Representing MNC’s in Board meetings of Drug Regulatory Authority
• Coordination with Ministries of Commerce, Finance, Health
• Active participation for approval of DRA after 18th amendment
• Media representation, Industry image building and relief program monitoring
• Analysis, comparisons & data management of drugs in Pakistan and Asian countries
• Conducting monthly review meetings, strategy building and implementation
• Pharma Bureau is an advocacy body representing country’s 23 leading multinational pharmaceutical research & biotechnology companies

• Project Title: Institutional Development Consultant, for Punjab Devolved Social Services Program (PDSSP) to achieve Millennium Development Goals (MDG)
• Present Project: (Phase I) Development of Standard Operating Procedures for Tertiary Health Care Facilities of Govt
• Of Punjab
• Prime objectives: Remedial Reform actions by improving standards and quality of health care provision to poor and needy population
• Scope of Work: (Phase I) Carried out extensive consultation with stakeholders and Workshops to develop understanding of Standard Operating Procedures
• Reviewed the existing system and written/unwritten operating procedure and their implementation practices
• Planned and improved Business processes for effective delivery of quality health care services from Tertiary Health care facilities
• Extensive Literature review, studied international Best Practices and implementation strategies
• Developed Standard Operating Procedures for Tertiary Hospitals based on International Best Practices
• Scope of Work: (Phase II) Development of action plan along with cost estimates for implementation of newly formed SOP’s in the province
• Work in coordination with the Provincial Health Department, Health Sector reform program and Social welfare department during the implementation
• Technical assistance and support in implementation of SOP’s in Tertiary Care hospitals

• Developed design and strategy for establishment of First ever Clinical Genetic infrastructure of Pakistan
• Plan approval from Management Committee, Jinnah Hospital and Govt
• Of Punjab, Health Department
• Developed PC-1 document and presented to HEC for funding
• Successful establishment of outdoor services for patients presenting with Genetic disorder
• Successful collaborations with other government and Non government laboratories for testing
• Training collaboration with University Hospital, New Castle Upon Tyne, UK

• Developed and implemented strategy and services of Voluntary Surgical Contraception use in Pakistan
• Developed and Trained Quality Team for monitoring
• Developed strategy and team for community Mobilization
• Evaluation and selection of Project proposals for funding
• Ensure the quality of the services as well as the appropriate use of its resources in conformity to the project contract
• Work in close co-operation with the Health Technical Unit and Operations Department
• Collaborates closely with other units at the project office and ensures good and regular contacts/briefing with related provincial and district authorities and other external stakeholders
• Technical Task: ensure To quality of the health activities through regular technical follow-ups and evaluation
• To represent the project, towards the provincial administrative and health authorities as well as the various coordination bodies
• Training tasks: To help capacity building of the project staff through coaching and support, training and adequate level of involvement in the decision-making process

• Establishment and organization of company’s first ever Medical Department
• Developed & Implemented Quality Standard Operating Procedures
• Registered company’s Key Products in record time
• Planned and led new product launches and business development
• Instrumental in achieving 100% Quality assurance of Insulin supply chain management
• Successful management of Phase IV trial for Hemophilia Patients
• Developing team for future management affairs
• Member of core Management Team
• Member of Board of Employee Induction Team
• Develop, implement and monitor SOP’s and systems for all departments
• Design, approval, budgeting and implementation of protocols
• Conduct training sessions for CRAs and sales representatives on ADR reporting and the importance of pharmacovigilance
• Communicate clinical scientific data to internal and external stakeholders including investigator meetings, scientific clinical advisory meetings, field medical & sales training
• Establish and maintain interactions with external medical and scientific experts to assess unmet medical needs in order to develop an appropriate medical strategy
• Manage Regulatory affairs & coordinate with MOH & lobbying
• Implementation & execution of NN quality procedures and activity plans
• Plans and monitor patient & nurses education program
• Monitoring and directing medical information, approval for external internal information dissemination to HCPs
• Execute individual medical strategic activities, specifically publications support abstracts, posters, manuscripts, review articles, etc, medical scientific advisory boards
• Organize and Advises development of education material & programs for medical doctors
• Devising training courses & conducting training of F.F

• Increased sales of Oncology products by 50% through planning & designing new marketing strategies
• Met targets throughout tenure, averaging more than Rs.57 million
• Developed & launched innovative Gynea products within budget & time frame
• Achieved target pricing for Yasmin
• (New low dose OC)
• Successful launching of Mirena.( First IUS in Pakistan)
• Successful IUS Hands on Training of Gynaecologists all over Pakistan
• Developed & Registered Society for the welfare of Multiple Sclerosis patients
• Consistently developed strong, sustainable relationships with Consultants and executive decision makers of Institutions
• Successfully maintained and increased Client base by designing and implementing strategic customer-retention projects
• Promoted to Business unit Head within 3 years
• Clinical Trial protocol designing, coordination and monitoring
• Coordinate Research activities on various products
• Manage Regulatory affairs & coordinate with MoH
• Develop medical training modules and training to F.F
• Design Standard Operating / Quality Procedures for various functions
• Attended several International Train the Medical Trainer Programs
• Training of KOLs for specialized drugs / procedures
• Manage marketing of the specialized therapeutic products
• Conduct market survey and competitor activity monitoring
• Innovative Product presentations to Opinion Leaders
• Monitor sales on daily basis by effectively managing the sales force

• Registered Company’s Product with the Ministry of Health
• Successfully completed one year of post marketing trial
• Demonstrated excellent talent and skills upon hired and excelled to become recognized by management as key member of the team
• Support and coordinator in development of protocols in accordance with GCP & declaration of Helsinki
• Conducting and monitoring the clinical Trials / research
• Responsible for drug regulatory affairs and registration procedures
• Development of training modules for F.F
• Responsible for medical and product related training of field force
• Deliver lectures on products to target doctors
• Scientific activity services to opinion Leaders
• Support function for regulatory issues and MOH
• Arrange conferences, seminars and round table discussions

Guided patients on medical treatments and digestive health concerns.

Handled crises with effectiveness and calmness. Managed emergency situations efficiently.

• Handled diverse patient care needs in urgent, clinical, and routine healthcare contexts.
• Worked in emergency & looked after oupatients as well