Deputy Pharmacovigilance Responsible Person

Deputy Pharmacovigilance Responsible Person

Gilead

Amsterdam, Netherlands

Gilead Sciences is seeking an ambitious individual to be the Deputy Pharmacovigilance Responsible Person (dPRP) to support the Pharmacovigilance Responsible Person (PRP) in all safety activities in Benelux.

This role will support the Netherlands and Belgium and is part of Gilead’s global Pharmacovigilance and Epidemiology (PVE) function.

This is a broad and all-encompassing, independent role that will undertake the management and conduct of all Pharmacovigilance activities; ensuring that local pharmacovigilance activities are conducted in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs).

Main responsibilities for the role include:

Overseeing the local Quality Management System:

  • Ensuring availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s);
  • Training Affiliate(s) staff on safety reporting procedures including the timely reporting of safety information to PVE/PRP e.g. new hire training, sales and solicited programs training and ensuring all training is documented;
  • Maintaining knowledge of global PDs as they pertain to Affiliate(s) and ensures that local PDs, including a Business Continuity Plan (BCP) are in place for specific local processes that are not covered by a global PD;
  • Ensuring an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented;
  • Reviewing the monthly global compliance reports produced by PVE and taking necessary corrective actions locally as applicable;
  • Performing applicable quality checks of local cases before routing, Regulatory Authority submissions if applicable and review of medical information enquiries;
  • Ensuring archiving of safety data in accordance with the Gilead’s retention policy and national requirements.

Maintaining local knowledge in relation to:

  • The Gilead Pharmacovigilance organization:
    • Local Regulatory Authority contacts and local Pharmacovigilance regulatory requirements (and communicating changes in requirements to PVE), specifically for submission of safety reports including PBRER/PSURs and creation of local Pharmacovigilance plans;
    • Studies and solicited programmes on going in their region.
  • Marketed status of Gilead products in the local countries:
    • Local licensing agreements (if applicable);
    • Safety related issues and forwarding any information that may be of relevance to the identification of potential safety signals to PVE / EU QPPV and local senior management.

Serving as the point of contact within the Affiliate:

  • For local Regulatory Authority inspections relating to Pharmacovigilance;
  • For interfaces between local affiliate staff e.g. for local solicited programmes, advice, support and review of contracts as necessary to ensure alignment with global standards;
  • Where required by local law may act as contact point for communication with the local Agency on safety submissions such as PBRERs/PSURs, Risk Management Plans and Risk Minimisation Activities and other safety matters;
  • Performing the role of the owner of the local Pharmacovigilance department and responsibility for associated local procedures.

Managing all aspects of local Individual Case Safety Report (ICSR) Management:

  • Collecting, recording, processing, translating and submitting AEs and special situation reports (SSRs) from all sources to PVE (including reports from local literature, websites and solicited programmes) in compliance with corporate requirements and local regulations;
  • Conducting appropriate and timely follow-up on all ICSRs, including use of targeted questionnaires;
  • Screening of local literature (where not covered in the global search) for Adverse Drug Reactions, SSRs or other relevant safety data;
  • Recording and maintaining ICSR data (including the management of follow-up) in the Local Affiliate Module of the global safety database (LAM);
  • Ensuring that appropriate ICSRs are notified to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements where applicable and recorded in LAM.

Utilising and proactively participating in the PRP Network and accessing available PVE resources:

  • Utilises PVE systems and resources such as the Agreement Repository, Drug Safety Shared drive and the PVE webpage to ensure access to up to date information including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File;
  • Attends quarterly PRP network video or teleconferences and an annual PRP face to face meeting where possible, and actively participates in PRP meetings to share best practices.

The ideal candidate will possess:

  • Scientific background along with a medico-scientific university degree e.g. Life Science;
  • Pharmaceutical research/drug safety experience in both clinical and post-marketing environment;
  • Comprehensive knowledge of global safety regulatory requirements and extensive knowledge of safety regulations pertaining to Benelux;
  • Working knowledge of European GVP and Regulations pertaining to Adverse Event Reporting;
  • Effective communicator (written and oral); concise, accurate and business appropriate;
  • Proven ability to work cross functionally;
  • Teamwork and initiative;
  • Excellent attention to detail and be able to demonstrate and deliver high quality work;
  • Ability to maintain confidentiality (especially on patients records), quality and accuracy;
  • Fluent written and spoken English and Dutch (required); good written and spoken French (desired).

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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