Job DescriptionAt Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.Job DescriptionThe Affiliate Patient Safety Senior Safety Specialist provides support to the 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.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, and Investigator Sponsored Research (ISRs)Local Subject Matter Expert (SME) for product safety: Provide expertise on product safety knowledge and Patient Safety position on safety mattersLocal Safety Contact Point:Audits and Inspections: Responsible for both internal PV audits and Regulatory Agency PV inspections in collaboration with 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 appropriateCommunication of Safety Information: Provide leadership and local decision making in collaboration with global Patient Safety on communication of Safety Information to external and 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 Patient Safety TA leads / 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 local Leadership TeamLeadership, 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:Responsible for local Patient Safety job descriptions, curriculum vitae and affiliate org chart are up to date with local safety activities and personnel.Maintain and input into local safety-related procedures.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.Deviations / Non-Compliance: Investigate and provide input into any local non-compliance corrective action plans related to safety.Responsible for appropriate safety out of hours process in place and have appropriate oversight.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 data and where applicable provide local data to the global team.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.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 practicePerform the local QPPV role as applicableAct as the safety consultant for local leadership teamsLocal Pharmacovigilance System Master File: Responsible for timely update and oversight in collaboration with global Patient Safety as applicableMaintain expert local knowledge and oversight of:The safety profile of locally marketed products and any emerging safety concernslocal 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.Local Legal reference document for AHoPS role: << Pharmaceutical Affairs Act_16250, Regulation on Safety of Pharmaceuticals, etc._1492>>A person who has obtained permission by item shall employ a physician, pharmacist, or oriental medicine pharmacist to perform the affairs of post-marketing safety management, such as re-reviewing new drugs, etc., re-evaluating drugs, and reporting side effects, as prescribed by Ordinance of the Prime Minister: Provided The person needs to take required training every 2 years, and training hours should be no less than 16 hours.Requirement:Affiliate Patient Safety2+ years of drug safety experience or 3+ years of clinical research/operation, Medical information or RA experienceBS degree in a life sciences field(nursing, pharmacy, biology) and pharmacy is preferredFor jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. 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