US Safety Expert- Bridgewater, NJ
Bridgewater, New Jersey
The primary responsibility of the US Safety Expert will be to partner strategically with internal cross-functional teams and company vendors to ensure full compliance with all internal, US and global pharmacovigilance requirements for all Patient Support Programs (PSPs), Market Research projects, and digital projects being run in the US while effectively meeting patient and business needs. As such, this role will ensure PV readiness and oversight for all such projects being run in the US by the Sanofi group (DCV, Sanofi Genzyme, GEM, Sanofi Pasteur, Chattem and Puerto Rico). Other responsibilities for this role include ensuring operational efficiency for the US Case Management process, oversight of PV vendors, and collaboration with Legal to ensure inclusion of PV language in contracts as appropriate. He/she will be responsible for identifying new ways of working and influencing internal stakeholders and external partners by assessing customer needs and proposing effective solutions. This role will contribute to Sanofi US Safety FDA inspection readiness. This role may also be called upon to perform activities related to quality documents, training, overall compliance oversight, periodic report coordination, safety data exchange agreements, and outsourcing.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
The US Safety Expert is responsible to:
- Serve as an important departmental liaison for programs/projects in US and Puerto Rico, providing expert oversight to the Sanofi Commercial Program Leader(s) and/or Services Providers to ensure that adequate provision for pharmacovigilance activities to meet global and local compliance requirements are put in place and continuously monitored to meet internal PV quality standards.
- Provide strategic contributions in the development, review and approval of Sanofi PSPs and MR projects conducted in the US and Puerto Rico to ensure, in partnership with the Sanofi PSP/MR project Leader, the inclusion of all PV requirements within the Services Providers’ contracts, including provision for PV data reporting, compliance auditing, a quality system, training, reconciliation, quality checks, and record retention;
- Perform and/or oversee the reconciliation of all PV data collected from Services Providers supporting PSPs and MR projects, and support the tracking of Service Provider Compliance with this activity;
- Support, as feasible, the delivery of the PV and PTC Requirements for PSPs and Market Research training to PSP and MR staff within and outside of the Sanofi organization;
- Participate in the assessment and integration/implementation of PSP/MR activities from all Sanofi GBUs into the Sanofi US Safety PSP/MR team, as applicable;
- Review and endorse the quality checks instituted by Services Provider(s) or Internal Staff for the oversight of PV activities;
- Serve as a liaison between the Sanofi US Safety PSP/MR group and GPV Case Management handling local or off-shore inquiries to coordinate the configuration of PSPs/MR projects in AEGIS and to provide updates to the case management team, to provide feedback to Services Providers or Internal Staff and to streamline processes;
- Review the MR tracking database (iTracker) to confirm compliance with the relevant PV requirements, i.e. reconciliation and Quality Control (QC) checks. Request AEGIS configuration of all Category 4 MR projects prospectively, and for all Category 2 and 3 MR projects retrospectively.
- Collaborate with GPV Operations to ensure operational efficiencies in of US case management processes and FDA submissions;
- Utilize advanced knowledge to continuously assess areas for process improvement and operational efficiency
- Foster relationships with internal and external partners from other functions (i.e. GPV, Legal, Medial, Commercial, Quality, Finance, HR, Communications, ITS, etc.) in order to achieve tactical objectives
- Facilitate the oversight of outsource vendors and the work submitted to Sanofi US Safety to ensure compliance with the approved process and timely submission of accurate cases;
- As needed, perform activities related to management of quality documents, PV data reporting training, overall compliance oversight, periodic report coordination, safety data exchange agreements, and outsourcing;
- Contribute to the Sanofi US Safety FDA inspection readiness by working cross-functionally with the GPV Quality team to ensure compliance with internal processes, as well as to ensure relevant CAPAs/RQNs are in place and to work toward their resolution/completion;
- Maintain continuous knowledge of current regulatory requirements and market changes
This position reports directly to the US Safety and Compliance Lead, Sanofi US Safety.
REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE
Bachelor’s degree from an accredited four-year college or university or equivalent work experience
Job Related Experience
2-3 years of experience in Pharmacovigilance, Quality or Commercial function
KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE
• High energy, positive attitude, strong work ethic.
• Good Team Coordination Skills.
• Project Management skills with ability to manage objectives, planning, budget, milestones and KPIs across a network or matrix.
• Ability to lead cross-functional teams and garner alignment between different entities
• Knowledge of regulatory requirements related to pharmacovigilance and other activities in scope
• Ability to manage and oversee outsourced partners to ensure continuity of the business
• Good Networking Skills.
• Excellent interpersonal and oral communication skills.
• Excellent interpersonal skills to work cooperatively with persons at all levels in the organization.
• Ability to respond flexibly and positively in all circumstances, and to work calmly under pressure.
• Attention to detail with a high degree of accuracy.
• Ability to exercise good judgment and discretion, especially with regards to sensitive or confidential personnel or organizational matters.
• Excellent computer skills and experience using spreadsheet, charting, and other software tools, such as Microsoft Word, Excel, PowerPoint, and Outlook.
• Fluent in English.
• Good computer literacy, communication skills.
• Ability to work in a multicultural environment across time zones.
Leadership Success Profiles
- Cooperate Transversally: Collaborate effectively with peers
- Strive for Results: Seek ongoing improvement of performance quality to create sustainable added value
- Lead Teams: Manage, motivate and empower transversal teams in the delivery of a PV system for patient programs.
- Technical Knowledge a plus
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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