Gilead Sciences, Inc. Senior Manager, Pharmacovigilance Responsible Person in Tel Aviv, Israel

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Gilead Sciences is seeking an ambitious individual to be the Pharmacovigilance Responsible Person (PRP) to be responsible for safety activities in Israel. This role is a local role; however 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).

The ideal candidate will possess:

  • Scientific background along with a medico-scientific university degree e.g. Life Science or hold an Israeli license in Pharmacy

  • 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 Israel

  • Working knowledge of Israeli Ministry of Health, ICH, European GVP, and FDA Guidance 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

  • Good communication skills

  • Good written and spoken English

Specifically the PRP in Israel is responsible for:

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 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 country(ies),

  • 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 safety related enquiries and serving as the local Qualified Person for Pharmacovigilance (QPPV)

  • 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 Pharmacovigilance Unit 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 on a weekly basis or according to journal publications.

  • 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 also be able to display engagement and commitment to the Gilead Core Values, which are:

  • Teamwork – Working together

  • Excellence – Being your best

  • Accountability – Taking personal responsibility

  • Integrity – Doing what’s right

  • Inclusion – Encouraging Diversity

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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