PRAHS

2017-41732

- | US-Remote | US-NC-Raleigh
6 days ago
Title
Senior Medical Director (GI)

Overview

Provides medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices. Also may assist Business Development group in tasks related to marketing and selling PRA services.
More Senior Level of Medical Director may take responsibilities of Functional Management.

Responsibilities

  • Provides medical expertise on clinical drug development throughout life-cycle of compound:
    • Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
    • Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates  and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
    • Provides therapeutic training relevant to specific study to the project team.
    • Attends and/or presents at investigator, internal and external project team meetings.
    • Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken.
    • Assumes responsibility for ethical, e.g. medical, aspects of study.
    • Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
    • Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
    • Assists the clinical team in selection and recruitment of investigational sites.
  • Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization:
    • Evaluates and assesses serious adverse events.
    • Generates and/or reviews notification letters to health authorities, investigators, IRBs and Ethic Committees.
    • Reviews, analyses and summarizes data for Data Monitoring Committees.
    • Contributes to and reviews Aggregate Safety Reports, evaluates benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options.
    • Contributes to and reviews Safety Management Plans, Signal Detection Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.
  • Provides benefit/risk evaluations and drug safety expertise for marketed drugs, diagnostics, and devices:
    • Evaluates spontaneous reports and literature cases.
    • Provides individual and cumulative benefit/risk assessments.
    • Communicates with reporting health care professionals, experts and consumers.
    • Reviews and authorizes Periodic Safety Update Reports.
    • Evaluates safety issues.
    • Recommends interventions to client.
    • Contributes to hearings at regulatory agencies and/or court.
  • Supports generation of publications and expert reports:
    • Reviews and interprets study results and clinical study reports.
    • Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations.
  • Supports Business Development (BD):
    • Builds relationships with new customers, maintains client relationships to obtain repeat business.
    • Identifies new business opportunities through contacts, literature, and conferences.
    • Promotes PRA through active involvement in scientific meetings and speaking engagements.
    • Contributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational execution.
    • Attends bid defense meetings including generating presentations and, takes active role in RFP discussions with clients.
    • Supports BD in client contacts to discuss portfolio and development strategies.

If applicable:

  • Responsibilities as EU Qualified Person responsible for Pharmacovigilance (EU QPPV):
  • With the marketing authorization application the marketing authorization holder (MAH) must provide evidence that the services of an EU Qualified Person responsible for Pharmacovigilance (EU QPPV) is in place. MDs residing in one of the EMA member states and adequately trained and qualified in all aspects of Pharmacovigilance might assume responsibility for the MAH’s pharmacovigilance system. Specific responsibilities of the EU QPPV or EU QPPV deputy may include:
    • Reviews and approves the Pharmacovigilance Master File (PSMF) and implements changes to PV processes.
    • Ensures compliance and timely submission of Individual Case Safety Reports (ICSRs).
    • Reviews Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs) to ensure compliance and timely submission:
      • Contact person for any agency questions or requests.
      • Determines the most appropriate person to sign the PBRER/PSUR.
  • Reviews and gives input for signal detection plans and activities
  • Reviews and provides input for European Risk Management Plan (EU-RMP).
  • Provides input to Investigator Brochure (IB)/Summary of Product Characteristics (SmPC)/Product Information/Labelling and safety variations.
  • Is involved in the preparation and conduct of any pharmacovigilance audits or inspections (incl. review of audit and inspection reports.
  • Reviews and gives input to training plans for staff members (PRA or client) who can be involved with receipt, processing and submission of ICSRs.
  • Is involved in review and sign-off of protocols of post-authorization safety studies conducted in EU.
  • Ensures conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Pharmacovigilance Practice (GVP).
  • Ensures necessary quality (incl. correctness and completeness) of pharmacovigilance data submitted to the competent authorities in Member States and the Agency.
  • Ensures a full and prompt response to requests from the competent authorities in Member States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
  • Provides any other information relevant to the benefit-risk evaluation to the competent authorities in Member States and the Agency;
  • Provides input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
  • Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency and for pharmacovigilance inspections as per legal requirements.
  • Assume primary medical monitoring responsibilities on global projects:
    • Leads and drives processes and solve problems, both, internally and towards clients on global projects.
    • Leads discussions with clients related to details on project set-up and conduct, as well as potential scientific misconduct.
    • Provides oversight of the generation of project plans such as Safety and Medical Management plans (SMMP) in close cooperation with project team during set-up phase.
  • Develops and implements training for project team members
  • Serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employees.

Operational Management

  • Monitors projects to assure profitability and associated project goals are being met:
    • Analyzes current and future project backlog in order to provide adequate resources to meet business objectives:
  • Manages operational functions of the group to meet project objectives for medical monitoring activities:
    • Builds and aligns a technical team to perform critical tasks assisting the medical monitors to achieve excellent medical coverage of clinical trials and sponsor satisfaction.
    • Monitors effectiveness and supervises technical systems being used /implemented for the Medical Support Center
    • Reviews relevant/assigned project tasks.
  • Identifies and supports the implementation of process improvements:
    • Review and update of medical monitoring SOP and associated work instructions and templates, identify need for and generation of new functional SOPs and work instructions
    • Maintains familiarity with current industry practices and regulatory requirements that affect medical monitoring.
  • Assists with bringing new business opportunities to PRA and maintaining existing client relationships for repeat business:
    • Interacts with clients and participates at client meetings as necessary to support and maintain new business.
    • Provides leadership in the delivery of related services to clients.
  • Ensures appropriate employee resources are available to meet corporate and project objectives for new and ongoing projects:
    • Reviews current assignments and utilization to ensure staff are resourced appropriately.
    • Provides identified resources to Resourcing or Delivery operational owners.
    • Ensures resources are adequately trained and performing.
    • Follows up assignments and performance.

Qualifications

  • 5-7 years of experience writing pharmaceutical or health-related documents.
  • 2 years of experience in a line management function.
  • Excellent communications and presentation skills
  • Experience using computerized systems (PC-Windows and MS Office).
  • Read, write, and speak fluent English; fluent in host country language.
  • Excellent project management skills.
  • licensed physician
  • Clinical practice and/or clinical research or drug safety experience.
  • Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal.
  • Profound knowledge of regulatory requirements.


To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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