Following the consolidation of Pharmacia Medical and PGRD Clinical Study Management and Monitoring (CSMM) functions with the Pfizer Medical & Research Division, the new MRD is a team of 40, headed by the Senior Director, Medical. The group is organized under five heads: Medical Affairs, Clinical Research, Regulatory Affairs, Medical Research Specialists, and Quality Standards and Training.
Medical
Affairs
Under the leadership of the Senior Medical Advisor, Medical Affairs, six Medical Advisors (product physicians) are responsible for providing timely, high quality, and ethical medical support and direction to marketing and sales efforts. . There is reason to believe that Pfizer India standards for support and services to marketing and sales are among the best in the industry. Medical Affairs staff provide the technical resources and expertise towards medical training of the sales force, new product development and launch efforts, ongoing support to the promotional effort on existing products, scientific presentations to the medical community, product-related advisory board activities, medical information system, and product-related technical support for clinical programs, labeling activities, and safety surveillance.
Clinical
Research
The Clinical Research group is responsible for all clinical research conducted within the country by Pfizer, irrespective of phase or product custodian. This group comprises of four organizational segments: Clinical Development; Study Management Service; India Regional Monitoring Group and Clinical Alliances & Outsourcing. About one-half of the clinical research portfolio relates to phase II and phase III studies executed on behalf of Pfizer Global Research & Development's (PGRD) worldwide development teams while the rest are phase III, phase IV comparative, post-marketing surveillance, epidemiology, drug utilization and biopharmaceutical studies to support local registration, launch and marketing. Pfizer has contributed greatly to the development of clinical research in the country and holds a position of leadership in this area. Initiatives such as the PGRD supported Academy of Clinical Excellence (ACE) in collaboration with the Bombay College of Pharmacy are helping to provide professional training to investigators and other clinical research personnel in the country.
Regulatory
Affairs
Regulatory affairs are managed by a group of five individuals responsible for registration of new products, obtaining clinical trial approvals, regulatory clearance of imports, safety reporting and labeling. Apart from responsibilities relating to the Indian market, the Regulatory Affairs group is often called upon to support operations and product commercialization in other countries within the India region, most prominently Nepal and Sri Lanka. Pfizer's recent efforts towards influencing federal regulatory policy have led to improvements in regulations and guidance's issued by the federal regulators.
Medical Research Specialist
The MRS function seeks to replicate the regionally based research function (Regional Medical and Research Specialists - RMRS) established in the US, UK and Canada. As custodians of Pfizer's image and reputation within the scientific community, the MRS will identify and collaborate with frontline clinicians and institutions in initiating and conducting leading-edge medical research and knowledge-based projects of high scientific relevance. The MRS will also partner with patient support groups and NGOs to develop and deploy programs of relevance to national healthcare needs.
As leaders in the development of therapeutic area knowledge for Pfizer, we expect the MRS to be sought by their clinical peers for their research expertise and support. With their specialized knowledge and unique research perspective, the MRS will be able to add value to sales and marketing initiated scientific and educational programs and support the advanced training needs of the organization. Operationally, the MRS will receive support from and collaborate with Pfizer's established Clinical Research and Medical Affairs functions.
Quality Standards and Training
The Quality Standards and Training Team is responsible for assuring Senior Management of compliance to all applicable Standard Operating Procedures (SOPs), regulations, rules, laws and statutes with regard to the conduct of MRD operations, including those involving other functions within Pfizer and/or external parties/ agents, and to constantly improve quality standards through review of documented responsibilities and procedures against desired outcomes.
This team is also responsible for documentation, tracking, and distribution of Pfizer Global Pharmaceuticals' SOPs and related training.
The team assists the Functional Heads in identifying need for new SOPs, as well as co-ordinating its development, maintenance, distribution, and updates. This team plays an important role in identifying training needs of MRD individuals and co-ordinating the training activities.
All local and overseas audits pertaining to country medical and regulatory activities are co-ordinated through the Quality Standards and Training group.
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