Manager Sales

Jeewan Prasad

******.******@*****.***

Mob: +91-875*******

Objective

To obtain a full time position that gives me an opportunity to apply my skills and knowledge of Life Sciences.

Professional Experience

Wipro Technologies Ltd, Greater Noida, UP, India

Pharmacovigilance Officer: Sep 2010 to till date.

• Involved in Collection, processing, quality control, coding, classification, medical review and reporting of case reports.

• Reviewed and audited Spontaneous as well as Solicited calls.

• Reviewed and audited Adverse Event Monitoring Forms as per seriousness and validation criteria.

• Involved in creation of validation of Pharmacovigilance database in Phoenix software.

• Involved in creation of DSUR, PSUR, and ASR.

• Responsible for management of safety cases processing/review and aggregated safety reports writing with pharmacovigilance services provider within agreed timelines and to a high standard of quality/accuracy.

• Contributed to safety risk management activities (e.g. signal detection, risk management plan) on the assigned key development product as the DS&PV representative in the project.

• Involved in creation of different levels of medical coding for adverse events as per MedDRA.

• Worded on Argus Drug Safety Database.

• Involved in creating Adverse Event Monitoring Forms, Product Quality Complain Forms and Medical Information Forms as per seriousness criteria.

• Involved in Case processing including data entry, review and assessment of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources in accordance with company SOPs and regulatory requirements.

Tech Observer (CRO), NJ, USA

Clinical Research Coordinator: June 2008 – Dec 2010

Therapeutic Areas: Oncology & Cardiovascular, Phase I-III

Clinical Research Exposure

• Involved in Protocol Development, CRF design as per CRF Completion Guidelines and ancillary forms such as source document checklist.

• Drafted Informed Consent Forms (ICFs) and reviewed the ICF prior to IRB approval submission and Prepared Investigator/study coordinator training manuals.

• Designed and set- up enrollment logs and maintaining excel spreadsheet to track all project related time lines and project related files such as regulatory binders.

• Involved in framing of inclusion/exclusion criteria in Protocol Development.

• Maintained regular telephone correspondence with the site for any site related, protocol related and contract related issues.

• Co monitored site visits as required for pre study, site initiation investigator meeting & interim monitoring to ensure compliance with protocol, SOP and ICH-GCP guidelines.

• Interacted with project director, medical director, project CRA’s, compliance personnel, data managers, biostatisticians and medical writing personnel to ensure the effective and timely completion of the study.

• Involved in assessment of investigator/study staff qualifications, recruitment potential and adequacy of site facility and equipments.

• Responsible for all aspects of study site monitoring including study start-up and close-out activities, verification of essential documents liaise with vendors; and other duties, as assigned.

• Responsible for verification and collection of regulatory documents.

• Review informed consents, source documents and case report forms for accuracy and completeness.

• Designed and set up enrollment logs and tracking systems.

• Assured strict adherence to study requirements as per protocol, GCP-ICH and SOPs

• Coordinated investigator meetings and quarterly study coordinator meetings

• Ensured serious adverse events are reported to the drug safety and to the regulatory authorities in a timely manner.

• Performed drug accountability for dispensing, storage & destruction during site close-out.

• Participated in site selection, initiation and interim monitoring.

• Ensured Informed Consent form (ICF) process assurance & audited Case Report Form (CRF) with source documents for accuracy.

• Ensured adverse events are reported in a timely manner.

Clinical Data Management Exposure

• Coordinated timely completion of all Data Management Activities for assigned projects following appropriate regulatory guidelines, company and department SOPs.

• Involved in creation and review of Data Management Plans, Edit Check Specifications, and Data Entry Specifications.

• Reviews Electronic Discrepancies and issues queries using Data Clarification Forms, viewing CRF Image, Group updates, Mass changes and reports and update database based on query responses, as well as Self Evident Corrections.

• Performed data review activities and interacted with clinical sites or the responsible CRA to coordinate error resolution using Data Clarification Forms, Monitored Initiated Correction Forms and Tracking CRF and Source Document.

• Tracked DCFs through Data Cleaning and Data Validation.

• Involved in Discrepancy management for paper and EDC studies in Oracle Clinical.

• Reviewed Clinical Trial Protocols and CRF design.

• Performed Serious Adverse Events and External Data Reconciliation e.g. lab data, in order to declare database cleaned and locked.

• Involved in Concomitant Medications (ConMeds) and adverse event coding using Adverse Event Reporting System (AERS) and standard MedDRA.

• Maintained CDM project documentation in an audit-ready manner.

• Involved in SAE reconciliation using Safety Database and Oracle Clinical Database.

• Maintained electronic records and clinical research process according to FDA regulations, 21 CFR Part 11 and ICH-GCP guidelines.

• Responsible for the development and testing of data entry screens and edit checks, and development of CRFs.

• Responsible for tracking CRFs, DCFs and daily reports.

• Participated in site selection, initiation and sometimes interim monitoring as co-monitor.

• Experience working in Phase I-IV of clinical trials from Start-up to Conduct to Data closure phase for therapeutic areas like Cardiovascular, Diabetes & Bacterial Infections.

Excel Drugs Pharmacy: Brooklyn, New York, US.

Pharmacy Technician: Sep 2006 – May 2008

Job Responsibilities

• Responsible for patient counseling.

• Responsible for admixtures and compounding medications.

• Responsible for entering prescriptions in computer, data entry, filling, creating payments & copayments and delivering it.

• Responsible for checking stocks and handling inventory management. Maintaining the track of drug inventories on computer and cash register.

• Responsible for maintaining the record of drug interactions and prescriptions on computer.

• Assisted in packaging as well as labeling of the medications according to government and pharmacy standards.

• Involved in communicating with administrative health personals for telephonic prescriptions, refills & accuracy of the records.

• Maintained the cleanliness and safety at work environment.

• Maintained record of long term patients.

• Filled electronic prescription orders from Physicians in QS1 Software.

• Performed office's daily routine activities.

• Responsible for answering calls and sending orders as per requirement.

• Responsible for inspecting patients and collecting their data from other pharmacists.

Zydus Medica (A division of Cadila Healthcare Ltd.) Indore, India

Business Officer: June 2004 - June 2005 (Ranked among India's top 10 star performers)

Therapeutic Areas: Cardiovascular, Diabetes & Neurology.

Job Responsibilities

• Marketed products to Physicians & Pharmacist in assigned geographical area.

• Organized seminars and conferences for Doctors and Medical staff's education and training.

• Made sales presentations to physicians with existing relationship and to others we will be prospecting.

• Generated market share for assigned products by volume and sales.

• Build and maintained positive working relationships with medical staff and supporting administration staff e.g. Receptionists.

• Managed budgets (for catering, outside speakers, conferences, hospitality, etc).

• Kept detailed records of all contacts and reaching annual sales targets.

• Planned work schedules, weekly and monthly timetables (involved working with or discussing future targets with the area sales manager, regional sales manager, product manager, general manager and plan how and when to target health professionals).

• Regularly attended company meetings, technical data presentations and briefings.

• Monitored competitor activity and competitors' products.

• Worked with team managers to plan how to approach contacts and creating effective business plans for making sales in a particular area.

• Make sure to make availability of products to assigned geographical area.

Computer Proficiencies

• Microsoft Suite: Access, Excel, Power-Point, Word.

• Software Database Packages: Oracle Clinical, EDC (InForm & RAVE).

Education

• MS in Pharmaceutical Administration, St. John's University, New York, US, May 2008 - 85%

• B Pharmacy, RGPV University Bhopal, India, May 2004 - 67%

Related Coursework

Biostatistics Public & Private Health Care System

International Drug Regulatory Affairs Global Pharmaceutical Marketing

Research Methods in Healthcare Marketing Understanding Consumer Behavior

Academic Exposure

• Graduate Assistant in Pharmaceutics Dept., St. John’s University, NY for 1 year.

Assisted Professors & Research students in their Projects and Lab works.

Taught 3rd year students in Lab, conducted and graded exams.

• Technical Assistant in Animal Care Dept., St. John’s University, NY for 1 year.

Maintained and tracked the log of Test and Standard animals.

Assisted Students in research and handling of animals.

Internship

• Socrus Pharmaceutical Ltd, Indore, India.

45 days of Industrial Training as a part of fulfillment of B Pharm degree.

Worked as Assistant Technician in Production and Quality Control Dept.

Affiliations

• Member of St. John’s University American Association of Pharmaceutical Scientists.

• Member of International Society of St. John’s University.

• Registered Pharmacist of Pharmacy Council of India.

• Member of Indian Pharmaceutical Association.

References: Available on Request.

DOB: 2nd May 1981

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