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Job Description
 

The Gilead Sciences, France Affiliate Patient Safety Senior Manager provides support to the Affiliate Head of Patient Safety (AHoPS) and global team to ensure strong engagement within the business ensuring engagement and integration within the affiliate. This position is involved in many aspects of pharmacovigilance coordination and execution at the affiliate and will provide back-up support to the AHoPS as required.

The France Affiliate Patient Safety Senior Manager performs the role of AHoPS back up/ local nominated Pharmacovigilance responsible person for France back up in accordance with local legislative requirements.

Key Responsibilities

Strategic PV partner

Patient Centricity: Responsible for bringing local insights to the decision-making process and into local benefit / risk and risk management development.

Local projects: Partner with Program Owners and commercial leaders to implement pro-active, efficient, and compliant solutions for the management of safety activities. Ensuring that relevant business partnerships have considered the impact to safety. e.g., awareness and input into new product launches and oversight of local solicited programs (Patient Support Programs, Market Research, Digital Media), providing support and review of contracts to ensure alignment with global standards. Partners to the global Patient Safety Solicited Program and Clinical Trial teams.

Local study strategic insights: Provide strategic input into local post marketing surveillance studies (PMS), local post approval safety studies, local sponsored studies, Investigator Sponsored Research (ISRs) and local early Access Programs called “Accès Précoce” and “Accès compassionnel”

Local Subject Matter Expert (SME) for product safety: Provide expertise on product safety knowledge and Patient Safety position on safety matters

Local Safety Contact Point

Point of contact within the Affiliate for safety related enquiries.

Audits and Inspections: Responsible for both internal PV audits and Regulatory Agency PV inspections in collaboration with Chief Pharmaceutical Officer (CPO) and local affiliates teams and global Patient Safety team.

Risk Management: Responsible for ensuring the appropriate development and revision of local RMPs and/or Country Specific Annexes in collaboration with global Patient Safety team and local Regulatory as required. Provide oversight & leadership of local risk minimization activities and materials as applicable.

Regulatory Intelligence & Industry Forums: Actively contribute to local industry forums, meetings, and seminars. 

Maintain expert knowledge of local pharmacovigilance regulations.Provide interpretation and communicate impact of changes in local pharmacovigilance regulatory requirements to global Patient Safety teamFeedback and influence local legislation consultations as appropriate

Communication of Safety Information: Provide leadership and local decision making in collaboration with global Patient Safety on communication of Safety Information to CPO and external & internal stakeholders, e.g.:

Submit or delegates submission of relevant information to the authorities as required locally via collaboration with Regulatory and global Patient Safety. To include but not limited to; PSUR, signals, RMP, PMS & responses to Health Authority inquiries.

Communicate safety related issues and information that may be of relevance to the identification of potential safety signals to CPO, Patient Safety Therapeutic Area (TA) leads / qualified person responsible for pharmacovigilance in the European Union (EU QPPV) and local stakeholders.

Pro-active PV forecasting

Integration into Business: Act as the Patient Safety ambassador delivering proactive PV knowledge & support to the CPO and local Leadership Team

Leadership, forecasting, and strategy: Build and maintain effective business relationships across the affiliate to support the implementation of Patient Safety standards.

Local Programs and Research: Oversight of local studies and local commercial and medical affairs projects and perform pro-active plausibility assessments.

Safety Monitoring: Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products locally.

Local Quality Management System

Ensuring that local pharmacovigilance activities are conducted such that the Affiliate(s) is in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs).

Actively participate to the Quality Committee and annual quality review for Exploitant status

Responsible for local Patient Safety job descriptions, curriculum vitae, affiliate organisation charts and training records are up to date with local safety activities and personnel.

Maintain and input into local safety-related procedures.

Maintain and input into local vendor Audit requirement through the audit plan oversight, in collaboration with applicable local and global compliance teams.

Responsible for ensuring high visibility and communication of Patient Safety within the affiliate.

Training and engagement: Offer engaging internal and external training leveraging technologies and other innovative methods of engagement.

Training Affiliate(s) staff on safety reporting procedures including the timely reporting of safety information to Patient Safety / AHoPS as per French specific requirements e.g. French Charter.

Deviations / Non-Compliance: Investigate and provide input into any local non-compliance corrective action plans related to safety.

Responsible for review of the monthly global compliance reports produced by Patient Safety and taking necessary corrective actions locally as applicable.

Responsible for appropriate safety out of hours process in place and have appropriate oversight. Responsible for ensuring that the system is tested at least annually and that the test is documented.

Individual Case Safety Reports:

- Perform annual review of Global Submission and Reporting Tool and provide real-time updates as applicable.

- Ensure appropriate visibility of local safety data and where applicable provide local safety data to the global team.

- If received, responsible for forwarding ICSRs to the global PS team for processing.

- Ensuring that appropriate ICSRs are submitted to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements where applicable

- Responsible for performing applicable quality checks and off-label use assessment review of France cases recorded in the global safety database, review of Regulatory Authority submissions and review.

Management of local literature as applicable.

Business Continuity: In collaboration with global Patient Safety ensure local PV continuity plan in place and is exercised annually and maintained and communicated to global Patient Safety team.

Perform data checks as required to ensure no missed safety reporting within the affiliate for example non-AE checks.

Responsible for ensuring appropriate data retention timeframes in place in collaboration with global Patient Safety and in accordance with national requirements.

Ensure awareness of local data privacy requirements and acts locally/informs global Patient Safety as needed.

Local Legal Pharmacovigilance Role

Active participation in AHoPS network, meetings and sharing best practice

Perform the local QPPV role as applicable

Act as the safety consultant for CPO and local leadership teams

Local Pharmacovigilance System Master File:  Responsible for timely update and oversight in collaboration with global Patient Safety as applicable

Maintain local knowledge in relation to Gilead Pharmacovigilance organization

Maintain expert local knowledge and oversight of:

the safety profile of locally marketed products and any emerging safety concerns or any non-compliant use identified according to the local requirement.any information that may be of relevance to the identification of potential safety signals and communicating to global Patient Safety / EU QPPV and local senior management as applicable.local studies and solicited programmes ongoing in the region and local post approval commitmentslocal licensing agreements (if applicable)Responsible for oversight of local safety post approval commitments.The Patient Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety webpage to ensure access to up to date information

KEY ROLE-RELATED COMPETENCIES / EDUCATION and/or EXPERIENCE REQUIRED

PharmacistConfirmed practical experience in pharmacovigilanceAbility to work with a high degree of autonomyComprehensive understanding of drug safety regulations and obligationsProven leadership or influencing skillsAbility to represent Gilead externallyExcellent communication skillsVery good written and spoken EnglishFluent French essential

 

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Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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