Safety Manager

Heena Patel Page * T: 805-***-****

HEENA PATEL, M.S., Doctor of Pharmacy

M: 805-***-****

GLOBAL DRUG SAFETY / PHARMACOVIGILANCE / MEDICAL

COMMUNICATIONS, / PEOPLE, PROJECT & PROGRAM MANAGEMENT / CRO AND VENDOR MANAGEMENT

Extensive global expertise and experience in leading and developing operational responsibilities including strategic planning, resourcing oversight, development of standards, affiliate support, training, safety operations, data management, CRO/vendor management, recruitment/retention within Global Drug & Patient Safety/Pharmacovigilance (PV), Medical Communications and Clinical Operations. Leading, directing and developing Global Safety Teams and deliverables for people, project and program management and execution. Thus, having increase in management/strategic responsibilities and leadership activities with every career move. A recognized leader and subject matter expert in stream-lining/implementing Standard Operating Procedures and Training globally. The point of contact and a key safety lead/liaison for the therapeutic area quality, compliance, filing and audit/inspection readiness activities. Committed team builder and a leader with successful track record of achieving high quality results and ability to establish rapport and credibility with diverse functions. Globally, recruited, trained and mentored Global Safety Officers, Research Safety Scientists, Medical Science Liaisons, Marketing / Commercial teams, Sales force, Clinical Development members, Regulatory Affairs, vendors, CROs, etc. Fluent in English, Hindi and Gujarati. Global leadership, experience and expertise in:

• Increase in management /strategic

responsibilities and leadership

activities with every career move

• Drug Safety/PV Operations, SOP

Creating and Management

• Drug Safety/PV experience from

Clinical Development through Post

Marketing

• Aggregate/Periodic Safety Reports

and Risk Management Plans

• Global Filing activities, Compliance

and Audit/Inspection Readiness

• Project/People/Program/Vendor/CRO

Management

• Med. Comm. / Mentoring / Training

MSLs; Marketing & Commercial teams

• Experience with various Safety

Databases

• Leading High-Performance Teams

• Quality, Compliance and Operational

Excellence

• Affiliates Support, Training, and

Pharmacovigilance practices

Heena Patel Page 2 T: 805-***-****

PROFESSIONAL EXPERIENCE

Voisin Consulting Life Sciences (VCLS) (October 2016-March 2017) Senior Director, Drug Safety & PV; Head of Redwood City Office, CA As a Senior Director, Drug Safety and Vigilance, following are few key responsibilities:

• Strategic and operational leadership in drug safety projects

• Mentoring role for all consultants in drug safety World Wide

• Business Development aimed at US clients for US/EU drug safety & post-market PV activities

• QA Advisor for US PV activities, key point of contact and liaison for audits and inspection As Head of the office, main responsibilities are:

• Develop, lead and manage a local team

• Create constructive positive working environment favorable to employee satisfaction/retention

• Supervise, coach, mentor and support the local-based consultants in performing their projects

• Build strong relationships with key local players in the Pharma, Biotech, Industry Associations California Life Sciences Association (CLSA etc.

• Increase VCLS visibility by participating in business development actions on the West Coast

• Ensure consistency of working practices and quality of the services, delivered to the client

• Promote VCLS values, culture and working methods within the office group

• Act as Client Manager on selective accounts and as Key Account Manager on some high priority accounts

Baxalta now part of Shire, Cambridge, MA (July 2015-Sep 2016) Head of Global Standards, Affiliate Support and Training Excellent leadership qualities globally in building, leading, directing and developing the infrastructure for Global Drug Safety (GDS) with good Pharmacovigilance practices and the Standards, Affiliates Support and Training team. Managed and facilitated deliverables for people, projects and programs. Recruited capable team members, coached, trained and mentored them along with the Global Safety Leads, Research Safety Scientists, Sales force, etc. across all therapeutic areas. Initiated, designed, developed, implemented, and facilitated robust operational, standards and training programs for GDS team members globally to ensure 100% compliance/quality and audit/inspection readiness. Proactively, developed streamlined and implemented GDS standard operating procedures (SOPs) globally and cross functionally. Governed and optimized the development, maintenance and launching of all on-boarding programs and functionally relevant information pertaining to GDS. Acted as a key GDS lead, liaison and point of contact to address and support the Global Affiliate/QPPV concerns and ensure alignment between Global and Regional functions. Thus, set up corporate direction for GDS/PV activities for ensuring corporate compliance with all Federal Regulations and as appropriate, foreign regulatory reporting requirements, for the processing and reporting of all Heena Patel Page 3 T: 805-***-****

Drug Safety deliverables for company sponsored drug products, including both drugs in development and marketed products.

• Build the infrastructure for the department, with the leadership skills, extensive expertise and experience in leading and developing operational responsibilities including strategic planning within the Global Drug Safety arena.

• Aligns departmental activities in support of corporate goals, as appropriate and monitor compliance.

• Collaborate closely with senior stakeholders across the business including but not limited to, Global Process Owners and Business Process Owners, The QPPV and members of product and process-related working groups and governance bodies. Thus play an influential role in continuous improvement and ongoing process innovation in the safety arena.

• As a leader and subject matter expert with good understanding of Regulations Globally, redefined, stream-lined, remodeled, developed and facilitated organization of Standards and processes. Lead and worked with the Subject Matter Experts (SMEs) cross functionally to finalize the SOPs and the related/required training materials. Thus, was able to develop robust SOPs and training programs cross functionally.

• Oversee and manage all the operational/standards/affiliate support activities. Related deliverables accomplished 100%, in a timely manner and respective standards and training assigned via ISOtrain (Learning Management System). Followed up and followed through via face to face or one on one meeting for the respective members/functions, thus managing compliance in various aspects for audits and inspections.

• Provided mentor-ship and coaching globally including Senior Leadership members on various applications (ISOtrain LMS, Baxalta Product Life Cycle Management (BPLM), BaxEDGE, etc.) and assisting them in navigating through the various systems.

• Demonstrated excellent collaboration and communication skills for managing the respective and appropriate standards and training to the New Hires within GDS and across other function within R&D. Also, directed them to the new hire on-boarding training program. Thus managing 100% compliance.

• Directed, developed and disseminated the required job descriptions for various newly identified positions within the department. Due to global experience in various areas/functions have been recommended by Senior Leadership Team to be part of the interviewing process and also acted as a SME for the development of the job descriptions. Thus was able to accomplish 100% in interviewing and hiring capable and excellent candidates.

• Acted as a key point of contact for my direct reports and the new hires, ensured that they were mentored and coached appropriately for their respective role.

• 100 % compliant in pro-actively managing the Standards and training requirements for all of GDS including the affiliates (for e.g. sales representatives, vendors, respective affiliates, etc.). Thus ensuring audit and inspection readiness by timely updates/revisions to the SOPs and training materials globally.

• With the hands on and can-do attitude was able take the lead on the BOX project (due diligence activities of acquiring products and data from the external company and ensuring 100% data transfer to the MAH). As the global lead oversaw, managed and monitored the transfer of the Global Drug Safety data. Efficiently represented GDS by collaborating and communicating with a diverse team on this project. With excellent Heena Patel Page 4 T: 805-***-****

problem solving skills and attention to details was able to work with internal and external members globally and confirmed 100% data transfer.

• As a GDS lead/liaison independently took the leadership and supported Talent Acquisition and HR team members with related activities for the new hire process.

• Oversaw and managed the compliance requirements related to housing Job Descriptions and CVs for all the GDS members and eventually for all of Baxalta at the time of an audit or inspection.

• Governed the updating, and finalizing of the Adverse Event Product Complaint Handling

(AEPCH) eLearning and the voice over narration process for various languages (14 different languages). This included the development of the accurate content for the AEPCH eLearning, collaboration with Quality for the Product Complaint content, managing and overseeing the vendor’s activities and efficiency, coordinating and harmonizing activities between vendors, ISOtrain, Quality, and GDS Globally, so the final product was available in a timely fashion.

• Strong work ethics, capacity to work in a very fast-paced environment and strength in multitasking (for e.g.: training issues, affiliates requirements, vendor SOPs and AE training requirements, developing presentations for SLT, reviewing Market Research Programs (MRPs) / Patient Support Programs (PSP) content and eLearning, negotiating with vendors on various issues (such as translations, PM, etc.) development of eLearning’s, development of cross-functional SOPs for Medical affairs and Medical Communications, etc.)

AMGEN, Inc., Thousand Oaks, CA (2005-2014)

Director, Global Safety Strategic Leader and Global Safety Program Manager Senior Safety Scientist, Global Safety

Managed, coordinated and facilitated Global Safety Teams (GST) and other functions involved in Benefit-Risk assessment, management and communication of Amgen molecules that progressed into late clinical development and/or are marketed. Assigned, distributed and managed projects and deliverables for GSTs (for e.g. lead and oversaw activities related to Aggregate/Periodic reports, streamlines SOPs, develop and provide training, proactive cross- functional collaboration and communication, etc.). Monitored progress of safety related projects and assessed quality of output/deliverables in collaboration with functional leaders from Global Safety, Regulatory Affairs, Audits/Inspections/Compliance and Clinical Development. Recruited, trained and mentored Global Safety Officers, Research Scientists, Global Safety Operations, Regulatory, etc. across all therapeutic areas. Managed therapeutic area pharmacovigilance senior managers, senior associates, CROs, vendors, etc. Acted as a key Global Drug Safety representative on QA, Regulatory Affairs, Medical Affairs and Communications, Global Development and Commercial teams. Governed and managed the production of key compliance safety documents. Developed and ensured timely communication of Global Safety priorities, strategies and deliverables to stakeholders, internal and external customers.

• Key role in re-organization and re-structuring of Global Safety and initiating development of Global Safety Teams for all therapeutic areas. Efficiency and productivity increased by 90% - 100%.

Heena Patel Page 5 T: 805-***-****

• Managed Therapeutic Area Pharmacovigilance senior managers, senior associates, CRO, vendors, etc. globally. Built on the infrastructure for General Medicine (Nephrology and Cardiovascular) therapeutic area.

• 100 % compliant on periodic update of safety information on Non- Amgen Medicinal Product (NAMP) used within clinical trials.

• Key point person for Safety and Regulatory filing activities globally, audits/inspections and readiness, compliance activities, strategic safety review, assessments and management ( e.g.: Investigator Meetings, DMC Charters & Meetings, Responses to Regulatory Authorities, review and approval of Safety Sections of CSR, Review and approval of 120-Day Updates, IB, DCSI, ICF, etc.).

• 100% compliant on developing and managing of narrative templates, writing and QC for the AEs leading to discontinuation of investigational product narratives for submission and filling activities.

• Developed, executed and managed updates to safety sections of various documents within Clinical Development. Provided review and 100% QC for the relevant and related documents (CSR, SCS, RTQs, etc.)

• Interfaced with internal and external customers in Safety related activities; supported GSO in key deliverables and represented Safety at key internal and external meetings.

• Governed and managed standard operating procedures and process for aggregate reports (PSURs/PBRER, PAER/PADER, DSURs, etc.), safety signal detection, Risk Management plans, etc.

• 100% implementation of Global Safety Teams and Product Safety Review Meeting

(PSRM) deliverables. Liaised with GST and other functions to ensure complete consistency for implementation of safety messages.

• 100% timely delivery of safety-related processes and outputs by the GST, including but not limited to: periodic/aggregate safety reports, clinical trial safety documents, signal assessment reports and safety contributions to ad-hoc regulatory requests.

• Initiated development of and evaluation of Safety deliverables in the Global Drug Safety document management tracking system.

• Key liaison for commercialization and other parts of the organization for creation of standard letters, ad hoc queries for Medical Communication, training support for Amgen employees on product safety issues, and contribution to all regulatory documents that have safety sections.

• Member of several Amgen committees and interdepartmental initiatives, e.g. Standard Operating Procedures, Business operating Procedures, Internal safety process, Audit/Inspection readiness, Product labeling working group, New role development, Global development teams, Global Regulatory teams, Clinical Study teams, etc.

• Routinely presented at internal cross functional and external meetings, including Senior Management, Quarterly Product Review, Global Investigator Meetings, and Data Monitoring Committees.

PFIZER Inc., New York, NY (1998-2004)

Director, Global Product Safety Surveillance Information (GPSSI); Senior Clinical Study Manager, Worldwide Atorvastatin Team, Medical Operations; Senior Regulatory Safety Manager, World Wide Safety (WWS). Heena Patel Page 6 T: 805-***-****

Governed and managed responsibilities for providing strategic direction in enabling the department to support the global initiatives. Responsible for managing and overseeing all the therapeutic teams, case processing, vendors, CROs, compliance with Periodic Reports, Audits and Inspection readiness, Operational activities, etc. Also, lead pharmacovigilance product support activities and oversee the medical information and safety evaluation activities. Thus, maintained 100% compliance for all the Global Safety deliverables. Acted as a key liaison between the Clinical Development and Global Drug Safety teams. Took initiative of developing and managing standards, processes and training for internal and external customers.

• With the leadership skills and experience in leading and developing operational responsibilities including strategic planning took the initiative of reviewing, revising and remodeling the SOPs for all the roles.

• All the related training and related deliverables accomplished 100% in a timely manner. Followed up and followed through via face to face or one on one training for the respective members.

• Provided mentor-ship and coaching globally including Senior Leadership members on various applications (LMS, Safety databases, etc.) and assisting them in navigating through the various systems.

• Provided strategic direction to the department in pharmacovigilance activities and maintained 100% compliance.

• Oversaw the reporting of safety information for all CHC products and ensured 100% global Regulatory compliance.

• Manage and oversee safety assessments for Rx to OTC switches and re-registrations.

• Lead the development and tracking of PSURs and periodic reports with 100% compliance.

• Development and maintenance of safety sections of licensing agreements.

• Took initiative, developed and oversee the medical information activities in the department for CHC products.

• Provide safety strategies for submissions in conjunction with regulatory and medical teams.

• Participated as the GPSSI, CHC representative on the safety interdivisional teams involved in strategic initiatives and tactical planning activities.

• Manage and oversee resource requirements and recruit appropriate members for GPSSI.

• Lead the Operational activities and manage Leadership team status reports and concerns and be proactive.

• Manage budget, estimate workload, plan for resource and facilitate cross - functional strategic planning discussions

PROCTER AND GAMBLE, Cincinnati, OH (1992-1998)

Senior Manager and coordinator for various functions: Medical Communications & Affairs; Clinical Medical Surveillance; Post Marketing Medical Surveillance. Heena Patel Page 7 T: 805-***-****

EDUCATION

Doctor of Pharmacy

College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA Master of Science in Synthetic Drugs and Chemistry Major: Synthetic Drugs. Other courses: Organic Chemistry, Inorganic Chemistry, Physical Chemistry, Natural Coloring Pigments, Analytical Chemistry, Industrial Chemistry.

University School of Sciences, Gujarat University, Ahmedabad, India Bachelor of Science in Chemistry, Biochemistry and Physics St. Xavier's College, Gujarat University, Ahmedabad, India AWARDS AND HONORS

• Audits and Inspections 2016

• Filing Activities for Various Products, 2006, 2007, 2014

• Organizing Information and Presenting at Investigator Meetings, 2001, 2002

• Initiating Automated Computer generated Periodic Reports, 1994 PROFESSIONAL ASSOCIATIONS

• American Heart Association (AHA)

• Drug Information Association (DIA)

VOLUNTEER

• Career coaching and mentoring for high school and college students

• Assisted and served as a key speaker for Women’s Day, Parent Teacher Conferences, Career days, etc.

• Key Public relations and point of contact for a Non-profit organization

Contact this candidate