Management Medical

Experienced in building long-term business relationships through proven project delivery systems using operational metrics that match biotech, pharma and medical device industry. Ability to improve productivity at all hierarchy levels.

15 years of Project management, regulatory strategy development and business development experience in the biopharmaceutical industry (public and private sectors) , including leadership and launch of a number of successful drugs and devices in a variety of therapeutic areas (Phase I-IV ).

NCE and Generic drugs for companies like Eli Lilly, ROCHE, Teva, GSK, Novartis, P&G,J&J, Eyetech, Qualissima and many medical device studies like Abbott ,Medtronic, Quest Pharmatech Inc (Canada) ,GE and Baxter International.

Providing metrics and performing Root-cause analysis of late single-case expedited reporting to the FDA, EMA, MHRA and documentation. Preparation and support of ICSR Regulatory Reporting Compliance metrics, ICSR Case Receipt Metrics, Aggregate report metrics and Root Cause Analysis.

Subject Matter Expert with Working knowledge of cross country reporting and country-specific legislations (e.g., German Drug Law, Indian Drug and Cosmetics Act). (EudraVigilance database, E2B gateway and data entry via web interface).

Active key member of NIH Safety Working Group (SAEC) , NCI AE Reporting group, CDISC Working group member ,MedDRA working group member and CTCAE Review committee member.

Bethesda MD 2007 – present

TRI Senior Director Safety & Pharmacovigilance

Global Operations & NIH & Industry Projects

• Providing strategic, supervisory and medical leadership in the area of drug development process and changing global Pharmacovigilance scenario (Eudravigilance).Playing key position using life sciences knowledge with primary focus on Clinical Development and Safety Data Management.

• Working on large projects for NCI, NIAID, DMID, CTN, NSABP and also on industry projects providing solutions for ongoing and new projects by liaising between users and software engineers. Responsible for the accurate and timely delivery of safety data and other deliverables by the affiliated partners.

• Planning and conducting user meetings, vendor selections and audits, participating in drug development meetings and developing project specific plans. Interacting with business development group in developing client proposals.

• Responsible for leadership and development of risk management plans. Compilation /documentation of aggregate reports, including periodic safety update reports (PSURs) and development safety update reports (DSURs) for all safety projects. Also preparing Summary Bridging Reports, Similar Event Analysis, Annual Safety Reports, Quarterly Reports, expert safety statements, A2Qs,Health Authority responses and MedDRA coding review as required. Harmonizing the requirements (different format, content, period covered and filing date) for PSURs as per different country requirements where the product is on the market. Working knowledge of CCSI, CCDS, DLP, listed AEs Vs Unlisted AEs and Summary Tabulations.

• Developing Strategies for safety information communication, safety signal detection, post marketing surveillance, development of REMs, label recommendations, stastiscal analysis of research data and PK/PD data analysis, signal detection plans as per user requirements and budget.

• Maintaining consistent high quality work and acquiring excellent client satisfaction by timely deliverables. Design metrics to track for productivity benchmarks, profitability and most efficient use of current resources. Ensure projects are properly resources and executed

Regulatory expertise: ICH E2B, ICH M2, ICH E2B, EU CT Directive

HIPAA privacy and security guidelines

21 CFR Part11 etc.

Regulatory Standards/ Languages: Standard Generalized Markup Language (SGML, ISO 8879:1986), ESTRI (Electronic Standards for the Transfer of Regulatory Information), CDISC ODM standards ,GCDMP ,GCP,GLP etc.

CDM/ Safety Tools: ORACLE AERS, ARIS G, ARGUS, Phase Forward Inform,

Empirica Trace and Study, DS explorer,

Clintrace, SAS, OpenClinica, DAERS, AdEERS etc.

Dictionaries: Dictionary versions of MedDRA and WHODD, dsNavigator and

Explorer, CTCAE 4.0

Regulatory documents/Reports: ICSR, PSUR, MedWATCH, CIOMS,

Annual Reports, IND, NDA, Line listings etc.

Study Documents / Tables: CRF, ICF, DCF, SDV, Randomization Schedules, Patient Diaries, Monitoring reports, DSMB summaries, SAE, AE forms, SOC Listings, Expedited report tables, Company SOPs and Project specific work instructions

Safety/ Data plans: REMS, SMP, Safety alerts, drug label preparation, safety data updates, Safety distribution lists, and common Risk lists for DAIDS, CTCAE for NCI, Company Core Data Sheets, Core safety information, Summary of Product Characteristics (SPC), IB and up to date Package Inserts ,PMPs, DMPs, Validation plans, UATs, Data Completion guidelines

Study Designs: BA/BE studies, ADME/Tox studies, Phase I to IV, Open label to double blinded studies

Systems: Windows NT/2000, Oracle, Siebel, Lotus Notes,Java, ASP, Microsoft office

Therapeutic Areas (Drugs& Vaccines) Infectious Diseases (AIDS, H1N1 etc), Oncology

CNS, Cardiovascular, Respiratory, Endocrinology

Major Accomplishments including

• Defined new Application implementation, AS-IS and TO-BE Process models for Clinical development and Safety Data Management projects.

• Developed and delivered NIH DAIDS Safety database training programs with global regulatory compliance through safety workshops in Thailand, India, Brazil and Uganda.

• Working with DAIDS EAE Manual, NCI AE reporting guidelines, DAIDS MedDra working group and CTCAE updates.

• Establishing flexible, scalable Operations plans as per the business requirements of different projects and done proactive identification of business problems. Enhancing existing operational plan to address these problems. Amend/adapt the existing system from the user's point of view.

• Working with different users from public and private sectors who has different specifications (different therapeutic areas, regulatory requirements).Preparing and different screens as per task. Preparing different report templates and modifying templates as per new RFPs.

• Developed large TRI Safety and Pharmacovigilance team staffed with highly-qualified medical professionals (MDs, PhDs PharmDs, RNs) and Data Entry Specialists who are well-versed in safety reporting regulations. This is a high throughput team, with experience receiving more than 4000 SAE forms per year for 600 protocols from 200 clinical sites through various channels (mail, fax, e-mail, websites) and entering data in different client databases (e.g. NCI’s Adeers, NIAID’s Phoenix/Reliant).My efforts have resulted in consistent outstanding ratings for our NIAID-DAIDS performance-based contract. All SAE forms will be processed in the system within 24 hours or less.

Tata Healthcare & Life Sciences – NY(USA) 2003 – 2007

Vice President Clinical Affairs- Pharmacovigilance

As Vice President, provided leadership in strategic planning, analysis, development, implementation and measurement of all aspects of drug safety and data management, medical services including signal management, risk evaluation and mitigation strategy. Shared valuable pharmacovigilance experience during my term at TCS (GSK). The focus of expertise was on both clinical and spontaneous adverse event reporting.

• TCS'($5.7 billion) ) Life Sciences business services cover the spectrum from drug discovery, clinical trials, clinical data management, statistical analysis, medical writing and drug development, to manufacturing, pharmaceutical sales & distribution and product management.

• Worked effectively in both oncology and anti-viral therapeutic programs including HIV expanded access programs. At GSK, served as a key member of the safety data design team that created and developed an innovative disease management algorithm and software program for oncology patients.

• Ensuring the correct documentation for US and International Regulatory submissions (CE markings), including 510(k), IDE, PMA Supplements, Design Dossiers/Change Notifications, and Technical Files.

• Partner effectively across and integrate with managers of functional areas like Clinical Data Management, Regulatory Affairs, Quality Affairs ,Clinical Pharmacology, Bioanalytical (DMPK) and contract vendors to establish company and study priorities and to ensure resource needs are met.

• Developed new programs/initiatives and assisted in the evaluation and development of new business concepts. Provided interpretation and education to the drug development team. Trained employees on data management, AE reporting, Patient medical records and physician correspondence during late phases of drug development (Phase IV).

• Developed customized comprehensive AE reporting system (Safety In a Capsule which provides risk mitigation ,flexible analytics and modular services through AERS, Siebel call center and Drug logic QScan for signal detecting)

• Successfully coordinated and completed FDA, WHO and other international regulatory audits.

Dr.Reddy’s Laboratories-Atlanta (USA) 2000 to 2003

Head Quality Assurance/Regulatory Affairs

• Defined, evaluated and ensured that drug products were studied using state of the art technology , manufactured and quality controlled in accordance with worldwide regulatory requirements for over 25 countries USA, CANADA, EUROPE, CHINA, BRAZIL, SOUTH AMERICA,NEW ZEALAND etc.

• Preparing, developing and writing clear opinions and explanations for new product licenses and renewals.

• Coordinating and managing all regulatory inspections.

• Responsible for regulatory documents to be sent to regulatory agencies like FDA,DCGI,MHRA in support of IND/CTA,NDA,CSR, BLA,ADR or other regulatory applications as needed.

• Developed a cost-effective, risk-managed regulatory compliance strategy to move products through each stage of clinical development (from Phase 1 through Phase 3) and into commercialization, and plan to maintain regulatory compliance once market approval has been obtained.

• Coordinating team during market responses (phase IV) with close monitoring, Label modifications or drug restriction. Track important emerging safety issues and ensure they are resolved in a timely manner along with Investigators.

• Worked on multiple products in therapeutic areas like Oncology, Anti-infective, and Diabetes, Pain Management, CNS (Schizophrenia, Alzheimer’s) Cardiology and anti obesity products.

Magee Women Research Center, UPMC, Pittsburgh Clinical Trial Manager---QA/RA

Nagarjuna Hospital, India Clinical Research Associate in Gastroenterology and Respiratory area.

UGH India As a medical resident trained in Medicine, Surgery, Obstetrics and Gynecology, ENT, Ophthalmology, Psychiatry, Public health etc.

EDUCATIONAL LISTINGS:

• Bachelors of Medicine &Surgery RMMC (Annamalai University) India

• Residency in Medicine University General Hospital India.

• P.G Diploma in Radiology International Institute of Medical Radiology India.

• Post graduate Diploma in Computers SAARC Net Limited India

• Masters in Immunology from University of Manchester. Manchester UK

• Clinical Laboratory Life Sciences(CLS), UPMC Pittsburgh

• SAS Certified Base Programmer for SAS 9.

Professional Societies

• American Registry of Diagnostic Medical Sonographers (ARDMS).

• American Society of Clinical Pathology (ASCP).

• Indian Medical council (IMC).

• Association of Clinical Research Professionals(ACRP)

• Society of Clinical Data management (SCDM)

• NIH Safety Working Group (SAEC)

• NCI AE Reporting group

• DAIDS CDISC Working group member

• DAIDS MedDRA working group member.

• CTCAE Review committee member.

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