Medical Safety

CURRICULUM VITAE

SINAI DAVIS, MD 201-***-****

* ********* ***. ******@*******************.*** Watertown, Massachusetts 02472

Experience: Pharma Doc Consulting, LLC

Watertown, Massachusetts

August 2016 – Present

President & CEO

Provide pharmacovigilance expertise in drug and medical device safety to Pharma/Biotech companies

Clients include Sanofi Genzyme, UNUM Therapeutics, Agenus

Karyopharm Therapeutics

Newton, Massachusetts

April 2016 – August 2016

Executive Director / Global Head of Pharmacovigilance

Built a Pharmacovigilance department by recruiting, hiring, training, and developing drug safety personnel to ensure the efficient operation of the pharmacovigilance department

Overall responsibility for leading the pharmacovigilance team and directing the safety surveillance of all company investigational drug products by implementing processes, procedures and systems (Oncology)

Served as the medical safety expert for all products in various stages of development

Negotiated contracts, interacted and supervised the activities of contract organizations and consultants for pharmacovigilance services

Established and managed independent Drug Safety Monitoring Boards (DSMBs) for clinical studies

Provided strategic planning, implementation and management of pharmacovigilance operations to support clinical development of company products

Shire Pharmaceuticals

Lexington, Massachusetts

May 2015 – April 2016

Senior Director / Medical Lead

Pharmacovigilance Risk Management

Led the development and execution of Risk Management strategies and authored internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities

Oversee investigational and post marketing regulatory marketing and pharmacovigilance activities

Medically review individual case reports from all sources

Oversee, prepare, and review Periodic/Annual Reports and Periodic Safety Update Reports and other Benefit/Risk Update Reports to Global Regulatory Authorities

Oversee, prepare, and review responses to ad hoc regulatory queries and other signaling topic reports

Led pharmacovigilance activities as a member of drug development project teams; lead safety review teams

Led safety labeling activities

Assisted the Vice President in developing and maintaining state of the art pharmacovigilance processes and procedures within Shire R & D, and as part of the Global PRVM organization, support the Qualified Person for Pharmacovigilance in the EEA relative to issues related to Shire products

Forest Laboratories, Inc.

Jersey City, New Jersey

November 2013 – December 2014

Senior Director

Pharmacovigilance, Risk Management and Safety Information (PVRM)

Provided subject matter leadership to global PVRM group

Monitored safety profiles of Forest products (CNS, Anti-infectives,

Anti-hypertensives, GI) including signal detection and trend analysis

Oversee the preparation of Risk Management Plans, DSURs, PSURs, PBRERs, PADERs, and REMS

Direct the epidemiological research in support of Forest products’ benefit/risk profile

Direct the due diligence for potential products for in-licensing

Supervise the writing of adverse event sections for package inserts, investigator brochures, and other labeling documents

Oversee the medical review of all adverse events and reports covering spontaneous reports and clinical trials, generation of aggregate safety reports and analyses, and preparation of investigator letters

Generate ideas and strategies to better assess safety profiles of specific products and develop overall methodologies in support of safety surveillance

Manage and coach PVRM physicians on:

oResource planning and recruiting

oPerformance management and setting objectives

oTraining, development, and coaching

oWork prioritization, resource allocation, and delegation

oIssue resolution/escalation

Provide safety and epidemiological oversight, strategy and guidance to therapeutic areas and other groups within clinical development

Ensure smooth and collaborative interactions with all other Drug Safety groups within the department

Represent PVRM at external professional organizations

Nektar Therapeutics

San Francisco, California

June 2012 – April 2013

Senior Director, Drug Safety

Overall responsibility for leading the drug safety team and directing the safety surveillance of all company investigational drug products (Oncology, Pain Management)

Analyze changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implement appropriate safety updates and risk mitigation plans

Serve as medical safety expert for all products in various stages of development

Direct the development and preparation of periodic and annual safety reports, investigator brochures, and product labeling/inserts

Provide strategic planning, implementation, and management of drug safety operations to support clinical development of company products

Recruit, hire, develop, train, and evaluate drug safety personnel to insure efficient operation of drug safety unit

Negotiate contracts, interact and supervise the activities of contract organizations and consultants for pharmacovigilance services

Manage compliance with SOPs, FDA, and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and investigators

Establish and manage independent Data Safety Monitoring Boards (DSMBs) for clinical studies

Participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and staff

Alcon Labs Inc.

Fort Worth, Texas

May 2010 – June 2012

Medical Director

Global Safety Evaluation & Risk Management

Global Therapeutic Area Team Head for Glaucoma, overseeing global group of MDs & Operations Personnel

Coordinated global and local product safety initiatives and provided proactive safety issue assessment/management for Alcon’s Pharmaceutical and Medical Device products

Provided strategic guidance and integrated safety input in terms of clinical development plans, technical assessments, protocol design, post-marketing authorization studies, regulatory authority assessments and submissions, and adequacy of safety data

Proactively assessed the benefit-risk profile of Alcon’s Pharmaceutical and Medical Device products throughout the entire lifecycle (Phase I – IV) and ensure safety information is communicated to the Vice President, Medical Safety and EU Qualified Person in a timely fashion

Reviewed and approved clinical trial protocols, study reports, investigator brochures, risk management plans, periodic safety update reports, and submission applications for designated products in partnership with the responsible Medical Safety Scientist.

Reviewed and provided safety information updates to local and core product labeling for designated products in partnership with the responsible Medical Safety Monitor.

Provided medical input to the evaluation of safety signals for designated products in partnership with the Pharmacoepidemiology group.

Medical review of individual AE case reports in workflow

Ferring Pharmaceuticals Inc.

Parsippany, New Jersey

December 2008 - November 2009

Director, Product Safety/Pharmacovigilance

Directed Product Safety Unit consisting of five professionals in the evaluation, management, and reporting of SAEs/MDRs for both marketed and pre-marketed products (Oncology, Women’s Health, GI, Orthopedic Medical Device)

Set overall department and project goals, timelines, resource requirements and budgets to achieve desirable results

Oversaw the establishment and maintenance of the systems, processes and SOPs that govern the US drug safety function

Led and coordinated company global medical device reporting

Ensured that drug safety had the appropriate infrastructure and was adequately staffed to consistently execute its surveillance, receipt, evaluation and reporting responsibilities in accordance with company SOPs and applicable regulations

Implemented EmpiricaTrace 4.2, Ferring’s first drug safety data base

Expert in MedDRA coding

Led Risk Management activities including the development of risk minimization action plans, safety strategies, and ensuring the robustness of the processes and procedures used to collect ADEs, MDRs, safety queries, and signal detection

Represented Ferring during regulatory audits by Competent Authorities

Worked closely with the therapeutic areas (GI, oncology, infertility, urology, orthopedic medical device) in design, development, implementation, and monitoring of safety issues through surveillance and pharmacoepidemiology methods

Provided medical input for reporting documents including: FDA Form 3500A; PSURs; Annual Safety Reports; Core Data Sheets; Investigator’s Brochures; Clinical Study Reports; Clinical Summaries and Clinical Overviews (benefit-risk evaluation)

Key member of IIS (Investigator Initiated Studies) and Grants committee

Provided medical insight and assessments for product acquisitions

Established appropriate metrics to set standards and assess the performance of the safety group

Identified and managed external contacts in government, academia and medical community to build strong relationships that enhance Product Safety’s visibility and credibility

Bracco Diagnostics Inc.

Princeton, New Jersey

December 2006 - December 2008

Director, Drug Safety and Pharmacoepidemiology (DSP)

North America and Rest of World

Head of Medical Device Vigilance and Reporting

Directed Drug Safety Unit, consisting of seven professionals in the management, reporting, and evaluating of AEs/MDRs for both marketed and pre-marketed products (Contrast Media, Cardiac Medical Devices)

Managed and tracked Key Performance Indicators (KPIs) for DSP NA and Rest Of World activities

Provided direction for developing and revising local processes, procedures, and SOPs

Led the Integration Team for the assimilation of the drug safety department of a newly acquired pharma company into the Bracco Drug Safety Group. This included drug safety database systems, personnel, and the creation of new processes and procedures to complement the two departments.

Developed and managed the DSP unit budget, staff, and operations

Prepared and reviewed documentation for world-wide Regulatory Authorities

Assured compliance for pre-marketed and post-marketed IPRs and periodic reports

Established and implemented reporting procedures with applicable affiliates, distributors, and licensees

Represented Bracco Group during regulatory audits and inspections of DSP North America/EU/Rest Of World

Under my direction, Bracco received no 483’s or discussion points as a result of an FDA inspection, the highest results attainable during an FDA audit

Led and coordinated company global medical device vigilance and reporting

Provided medical support in planning and implementing corporate drug safety programs/projects, and medical support to World-Wide Medical & Regulatory Affairs

Assigned responsibilities to DSP North America/EU/Rest Of World personnel

Coordinated and approved yearly training programs for DSP personnel

United States Food and Drug Administration

Parsippany, New Jersey

Office of Regulatory Affairs

June 2001 - December 2006

Consumer Safety Officer/Investigator

Conducted Pharmacovigilance Inspections, consisting of comprehensive reviews of drug firms’ ADE collection, processing, evaluation and reporting procedures

MedWatch Coordinator for New Jersey District Office

Conducted various complex levels of scientific evaluations and inspections of pharmaceutical and medical device firms

Collected complex samples during drug investigations

Conducted Bioresearch monitoring (clinical trials) of drugs and medical devices

Reviewed, analyzed, and prepared reports of investigation findings

Collaborated with local, state, and federal FDA officials

Interfaced with all levels of scientific and managerial personnel of FDA regulated firms

Represented FDA in court

Provided training to new investigators on investigation and inspection techniques and sample collecting

United States Department of Justice

Health Services Division

December 1990 – June 2001

Metropolitan Detention Center, Brooklyn, New York

Assistant Health Services Administrator, 7/98 – 6/01

Directed operations for a 1500 patient ambulatory care facility

Orchestrated activation of a new 2500 patient ambulatory care facility

Supervised a staff of 12 physicians, 2 medical records technicians,

1 X-Ray technician, 1 lab technician, 2 pharmacists, 1 dentist, 1 dental assistant, 3 paramedics

Supervised 15 outside medical contractors, including surgeons,

orthopedists, ophthalmologists, ob-gyns, and others

Controlled inside and outside medical cost centers, each with

budgets of over 1 million dollars

Managed the health services budgets, which included the

purchase of all medical and dental supplies and equipment

Initiated medical referrals for community hospitalizations

Directed all elements for JCAHO, ACA, and Program Reviews

Actively participated in the medical practice of the institution

Organized monthly Continuing Medical Education program for staff

Federal Correctional Institute, Fort Dix, New Jersey

Assistant Health Services Administrator, 12/95 - 7/98

All duties as above, for 4000 patient ambulatory care center

Directed the JCAHO, and received Accreditation with Commendation

Oversaw the operation of 2 separate Health Services Units

Supervised a staff of 43 medical personnel

Directed two cost centers, with budgets of over 2 million dollars

Metropolitan Correctional Center, New York, New York

Staff Physician, 12/90 - 12/95

Clinical duties included coordinating Radiology Department, conducting

medical clinics, holding sick call, and administering medications

Instructor/Supervisor to the Physician Assistant students on staff

Promoted to Assistant Health Services Administrator at Fort Dix

Education: CEUX School of Medicine, Baja, California, Mexico: Medical Degree

University of Alabama, Tuscaloosa, Alabama

Bachelor of Science, CUM LAUDE, Microbiology

Received numerous awards and commendations from the FDA and the US Department of Justice for outstanding achievements and accomplishments in both medical and administrative duties.

Membership: American College of Physicians

Drug Information Association (DIA)

Association for Research in Vision and Ophthalmology (ARVO)

Languages: Spanish and Hebrew

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