Amy Wain

Amy Wain Email and Phone Number

Director Drug Safety And Pv, Fortrea @ Fortrea

Amy Wain's Contact Details

Amy Wain personal email

n/a

Amy Wain phone numbers

Amy Wain's Current Company Details

Fortrea

Director Drug Safety And Pv, Fortrea

Amy Wain Work Experience Details

  • Director Drug Safety And Pharmacovigilance
    Fortrea ['Jun 2015', 'Present']
    Durham, North Carolina, Us
  • Director Patient Safety Solutions
    Labcorp Drug Development ['Sep 2017', 'Oct 2022']
    Burlington, North Carolina, Us
  • Director Of Pharmacovigilance
    Chiltern ['Jun 2015', 'Sep 2017']
    Durham, North Carolina, Us
    • Responsible for the selection, training, development, and performance management for a team of Pharmacovigilance staff, including line managers and directors. • Lead the strategic development of the Chiltern Pharmacovigilance department, consistent with the company’s corporate direction and meeting the needs of current and future clients.• Provide input to PVG budgets for proposal development; create strategies for successful business development. • Develop strong relationships with clients; key client contact for PVG standalone programs• Ensure that PVG resource levels meet the needs of an assigned region• Ensure that PVG activities are supported by robust procedures (SOPs, WPDs etc.), and up-to-date electronic systems sufficient for the scope of activities provided• Lead efforts to improve departmental efficiencies, including notification of problems, in collaboration with the Chief Medical Officer• Ensure metrics are tracked to demonstrate compliance with PVG reporting timelines.• Represent the department in Sponsor meetings (capability, bid defense, program meetings). • Ensure the PVG department has and maintains up-to-date knowledge to meet all country and region-specific PVG regulatory requirements, and as well as required timelines for reporting SAEs to Regulatory Authorities and Ethics Committees
  • Associate Director, Pharmacovigilance
    Ppd ['Nov 2007', 'Jun 2015']
    Wilmington, Nc, Us
    Responsible for general oversight of North America Pharmacovigilance operations and management of PVG Managers, Safety Specialists, Safety Physician Coordinators and other PVG staff. Provide a high level oversight and support of PVG staff:- of overall aspects of safety processing including, study start up procedures, study management and safety database activities (clinical trial and post-approval PVG)- of the Global Data Monitoring Committee (DMC) operations and management of the activities of the department Managers, Safety Specialists, and other departmental staff responsible for DMC coordination - of medical management services, primarily safety data listing reviews - of the Global bidding team (clinical trial and post-approval PVG); providing strategic oversight to contract proposals and business development opportunities Provide department and company training and mentoring to PVG staff and other company employees. Participate and lead departmental (staff/management) and corporate meetings in the planning, implementing and evaluating of new initiatives.Collaborate with the PVG Managers to ensure contracts are appropriately managed and assist with implementation of contract modifications. Assist the Director of PVG with the technical and operational aspects of PVG services to ensure the successful completion of the all contracted deliverables.
  • Pvg Manager
    Ppd 2002 - 2007 · 5 yrs
    Wilmington, Nc, Us
    Responsible for the coordination and management of contracted safety responsibilities for multiple research projectsEnsured compliance with corporate SOPs/WPDs, policies, and regulatory guidelines and requirementsResponsible for the management of safety specialists and the overall coordination of the SAE processes for all PVG projectsResponsible for the management of the Data Monitoring Committee (DMC) staff and the overall coordination of global DMC processesProvided oversight, and support for training of new PVG staff, study start up procedures and safety database activitiesAssisted with preparation and presentation of marketing proposals and bids, investigator meetings and kick-off meetingsInteracted globally with the Medical Affairs/Pharmacovigilance teams, the clinical project teams, Data Management and Biostatistics
  • Safety Specialist
    Ppd 1999 - 2002 · 3 yrs
    Wilmington, Nc, Us
    Responsible for the overall coordination of the SAE processes for designated projectsManagement of global safety on complex studiesMaintained knowledge and understanding of PPD SOPs; current FDA regulations regarding clinical trials, regulatory documents and safety issuesOversaw expedited reporting for designated projects and assist staff as neededEffectively interfaced with project teams, Client Company, and investigators regarding safety activities from project start-up through database lockCoordinated safety database activities for assigned projects.Oversaw, maintained, and updated PVG budgets for assigned projects.Participated in Project Team and Executive Review Meetings to communicate progress of PVG quality, budgetary or operational issues.Provided department training and mentoring of Safety Specialists and new employees.Chair of the MA/PVG Committee; coordinated and assisted in the preparation and revision of department SOPs, WPDs, and PVG Guidelines

Amy Wain Education Details

  • University Of North Carolina Wilmington
    Nursing 1989 - 1992
  • Fayetteville Manlius High School
    1977 - 1981

Other Similar Profiles

View similar profiles

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.

Frequently Asked Questions about Amy Wain

What company does Amy Wain work for?

Amy Wain works for Fortrea

What is Amy Wain's role in his/her workplace?

Amy Wain's role in his/her workplace is Director Drug Safety And Pv, Fortrea.

What is Amy Wain's email address?

Amy Wain's email address is am****@****ern.com

What is Amy Wain's direct phone number?

Amy Wain's direct phone number is +191054*****

What schools did Amy Wain attend?

Amy Wain attended University Of North Carolina Wilmington, and Fayetteville Manlius High School .

What are some of Amy Wain's interests?

Amy Wain has interest in Children, Arts And Culture, and Health.

What is Amy Wain's role in his/her workplace?

Amy Wain has skills like Pharmacovigilance, Clinical Trials, Cro, Clinical Development, Ctms, Ich Gcp, Gcp, Sop, Oncology, Therapeutic Areas, Clinical Data Management, Edc, Infectious Diseases, Clinical Research, Pharmaceutical Industry, Clinical Monitoring, Regulatory Submissions, Fda, Post Approval Safety, Critical Care, Dmc, Business Development, Spotfire, Cro Management, Clinical Trial Management System, Good Clinical Practice, and Standard Operating Procedure.

Who are the industry peers of Amy Wain at other companies?

Amy Wain's peers at other companies are Prasanna Rani Genupala, Dinesh Kasthuril, Mariana Adelino, Carina Trigueiro Borba, Mary Ellen Ellis, and Jaimin Patel. and Stanislava Kranzhalova. Amy Wain's peers at other companies are Prasanna Rani Genupala, Dinesh Kasthuril, Mariana Adelino, Carina Trigueiro Borba, Mary Ellen Ellis, and Jaimin Patel. and Stanislava Kranzhalova.