Medical Sales

SYED SHAHID HUSSAIN, M.D.

*****, ******** **,

Laurel, Maryland 20708

Phone. 301-***-****

E-Mail: ****************@*******.***

OBJECTIVE:

Seeking a management position in Medical Affairs, Regulatory Affairs, Clinical Trials Management, Pharmacovigilance, Medical Information & etc.

PERSONAL ATTRIBUTES

Over fifteen years of experience in leadership and management in healthcare and pharmaceutical industry. Experience spans from clinical practice, patient care, research, academia, business development, project and team management, documentation control and submission of new registration dossiers (NDA) to the regulatory agencies in Pakistan. An enthusiastic professional with a proven track record of success and leadership in medical / clinical / regulatory affairs in the pharmaceutical products promotion, manufacturing and distribution industry. A strong communicator with a passion for success and achievement.

PROFESSIONAL EXPERIENCES

Manager Medical & Regulatory Affairs November 2008 to Present

BARRETTHODGSON PAKISTAN (PRIVATE) LIMITED Exclusive distributor and licensee with AstraZeneca (UK) , Allergan ( USA), Astella (Japan) of pharmaceutical products and drugs in Pakistan

• Medical Affairs: Responsible for supporting Marketing Department with symposia & round table discussions with opinion leaders and physicians in the country. Vetting of promotional literatures for drug marketing to the IFPMA code of Ethics and compliance with the ministry of health. Provided innovative product support to promotional campaigns and assisting in positioning the products according to the latest innovations in healthcare and medicine. Providing sales support and liaising with physicians who are key opinion leaders (KOLs) in their respective areas of specialties.

• Regulatory Affairs: Responsible for preparation of NDA (New Registration Dossiers) with the support of QA for new molecules either for import or for local manufacture for submission to the Ministry for Health and also submission of registration renewals application of already marketed products and follow up with the MOH for approval. Any other affairs related to the Ministry of Health like queries, price increase request or Hardship Case were prepared, submitted and followed up with the MOH for approval.

• Additional responsibilities included supporting Evanta Pharma, a subsidiary of Herbion Pharmaceuticals for registration for export of Barrett Hodgson products to CIS countries and registration of products for Toll Manufacturing for Martin Dow and Roche in Pakistan.

• Medical and Regulatory Affairs Contact Person of Barrett Hodgson Pakistan (Private) Limited for AstraZeneca & Allergan, USA products in Pakistan.

Some achievements at BarrettHodgson Pakistan (Private) Limited

• Over 26 new products registered by the MOH and more than 80 new registration dossiers submitted to the MOH in my period of service of two and half years.

• Submission of Hardship Cases of nearly 10 products for price increase and received approval for 8 products.

• Of the 165 registered and marketed products of BHP renewals application for registration of nearly 80 products submitted and approved by the MOH.

• Eight products and twenty formulations of products of BHP submitted and approved by the MOH for export by Evanta Pharma to CIS countries.

CONSULTANT AT IT FIRM

(February 2007 to October 2008)

• Worked as a Consultant at an IT firm for developing Software for the processes involved in the daily working of the Medical & Regulatory area of responsibilities in a Pharmaceutical company.

PFIZER LABORATORIES LIMITED PAKISTAN

Head of Medical Division)

(August 1992 – January 2007)

• Joined as a Clinical Research Assistant in 1992 and was promoted to different levels and finally became the Head of the Medical Division on June 1, 2002 till January 23rd, 2007.

• Managed 7 physicians and 2 management persons working in the Medical Division

THE JOB DESCRIPTION AT PFIZER PAKISTAN WAS THE FOLLOWING:

• Managed the Product Physicians in providing support to the Marketing with development of Promotional Literatures, scientific presentation, identification of Chairman, Speaker and Moderator for activity planned by Marketing, answering to queries received by them directly or through the Sales Force, and also call on doctors at large at the request of the Sales Force and etc.

• Managed the Quality Standard Process Implementation Manager by providing guidelines for development of Curriculum for training of the members of the Medical Division and SOPs as is mandatory in Pfizer under the role of QSPIM.

• Managed the Regulatory Manager with New Drug Application (NDA) for New Molecule for submission to the Ministry of Health either for import or local manufacture, preparation of registration renewals applications of either imported or local manufactured products, Price reconsideration applications or Hardship cases for products or any other issues related to the MOH.

• Managed the conduction of Clinical Studies either Local Studies which were Phase IV Studies, or for the Pfizer Global Research & Development, or participation in Regional Clinical Studies Phase IIIA or Phase IIIB, Write papers based on the clinical trials conducted for publication in either International or Local Medical Journals.

• Managed the Medical Specialty Managers in providing support to the Sales Force initiated activities like Round Table Discussions, Exposia, Film Shows and Symposia with Scientific Presentation or Data, along with identification of KOLs to act as Chairman, Speaker and Moderator for the Scientific Event. Visiting with the Sales Force, doctors, who are either difficult or have some technical queries and etc.

• Support Training Department by imparting training to Sales Force in basic anatomy, physiology and pharmacokinetics as well as the clinical aspects of products marketed.

• Pharmacovigilance Contact Person for reporting of adverse events to the Head Office in New York, Regulatory Contact Person for updating the status of Regulatory submissions to Pfizer Inc via Global Regulatory System website, and updating the PFLITE system, a website for updating the Local Product Documents of every products of Pfizer in accordance to the International Product Document.

Some of the Achievements at Pfizer Pakistan:

• Preparation, submission, follow up with MOH of New Drug Applications (NDAs) and finally getting registration approval for marketing of the following products like Xalacom, an Ophthalmology product for patients suffering from Increased Intra-Ocular- Pressure, Macugen, an Ophthalmology product for patients with Acute macular Degeneration in a record time of 3 months, Zeldox, for patients with Schizophrenia, Caduet, a combination of Atorvastatin and Amlodipine for patients with comorbid conditions of Dyslipedemia and Hypertension, Lyrica for patients with Neuropathic Pain, Exubera (Inhaled Insulin) for Diabetic patients on injectable insulin, Chantix (varenicline tartarate) for smoking cessation.

• First Prize for the Pfizer Pakistan in the Asian Region for a Project of Outcome Research.

HOSPITAL CONSULTANT ASSISTANT & TEACHING FACULTY AT CPSP

(February 1982 – August 1992) & (July 1987 – February 1992)

• Worked as Assistant to Consultant a Professor of Medicine, Jinnah Post Graduate Medical Center, Karachi. Worked at the College of Physicians and Surgeons, Pakistan as Medical Officer and was associated with teaching programs for postgraduate students and have been teaching classes for Fellow College of Physicians & Surgeons (FCPS) Part-I and Member College of Physician & Surgeons (MCPS).

CLINICAL EXPERIENCE

(JULY 1981 – FEBRUARY 1982)

• Worked in the Department of Medical Unit - IV (Chest Medicine), Jinnah Post Graduate Medical Center from July 20, 1981 to February 19, 1982.

TRAINING:

1. Product Managers Training Program at Istanbul, Turkey organized by Pfizer Inc, New York, USA in January, 1993.

2. Medical Training Seminar arranged by Pfizer Inc. New York, USA in September 1993 in New York USA.

3. Field Monitoring Module Training Course of Pfizer Corporate Clinical Research Education System (CCRES) in Singapore in October 1995

4. Good Clinical Practice Workshop arranged by Pfizer Philippines, at the University of Philippines in Manila, from June 3-4, 1999.

5. Media Coaching Training arranged by EMA International in Dubai on January 19, 2005.

PUBLICATIONS:

1. Clinical trial’s paper “Clinical Evaluation of the Efficacy and safety of Piroxicam Gel (0.5%) in the treatment of Acute Musculoskeltal Disorders, conducted by Prof. Naseer Akhtar, Principal and Professor of Orthopedic Surgery, Allama Iqbal Medical College, Lahore. Published in “The Specialist Quarterly.”

2. Clinical trial’s paper “Clinical Evaluation of the Efficacy and safety of Piroxicam Gel (0.5%) in the treatment of Sports Injuries” conducted by Dr. A Moeed Kazi, Head of the Department of Physical Medicine and Rehabilitation, Jinnah Post Graduate Medical Center, Karachi. Published in the “Pakistan Medical Journal.”

3. Clinical trial’s paper “An Open Non-Comparative Study of the Efficacy and Toleration of Amlodipine in Mild to Moderate Essential Hypertension in General Clinical Practice.” Conducted at five centers with five investigators. Published in”The Professional” quarterly.

4. Clinical trial’s paper “An Open Non-Comparative Multicentre Study of Efficacy and Toleration of Amlodipine in the treatment of Mild to Moderate Essential Hypertension I General Clinical Practice.” Published in the “Quarterly Medical Channel.”

5. Clinical trial’s paper “An Open Non- Comparative Study of the Efficacy and Toleration of Amlodipine in the treatment of Mild to Moderate Essential Hypertension in General Clinical Practice.” Published in the Pakistan Journal of Medical Research.

6. Co-author of “Low – HDL Cholesterol in South Asian Population, Is It A Major Risk Factor for High Coronary Heart Disease” published in the International Society of Pharmacoeconomic & Outcome Research Journal, March 5, 2006.

LANGUAGES: English, Urdu & Bengali

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