Pharmacovigilance Case Management Lead

Success Profile

COMPANY SUMMARY
At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Fast Moving Consumer Healthcare Business. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.

As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity.

JOB PURPOSE

The Pharmacovigilance Case Management Lead is a member of the CHC PV Operations team and reports to CHC Case Management Lead.

This position is responsible for the overall Global Individual Case Safety Report (ICSR) quality assessment in the workflow and US PV operations management for CHC products

KEY RESULTS/ACCOUNTABILITIES

Case Quality Responsibilities:

• Develops, reviews, implements, and/or validates new metrics presentations, visualizations, and reports
• Responsible for resolving complex issues related to day-to-day activities independently, determining when to escalate issues to senior management, and oversight of vendor resources
• Documents, monitors, and trends reasons for late submissions and opening Quality Investigations for identified trends
• Investigates and documents scores below quality thresholds
• Responsible to monitor vendor case processing quality for all global CHC cases
• Partners with the operations teams, global case processing centres, and Affiliates/CSH to develop strategies for quality improvements
• To implement inline quality check process and effectiveness of the CAPAs for quality issues
• Participate in audits and inspections as Subject Matter Expert (SME) for PV submissions and Quality activities, performing User Acceptance Testing (UAT) of reports, and visualizations, as necessary

Case Submission Responsibilities:

• To generate user requirements for technology enhancements for inbound processing and lead the implementation from a business perspective
• Case relevant information processed in the system is distributed and reported according to the case management SOP to fulfill legal and partner agreement compliance requirements
• Responsible to manage submissions to USFDA from safety database
• Lead cross-functional compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate
• Responsible for US case management activities and other PV ops related activities including but not limited to Inbound & outbound reconciliation, submission, late case analysis, inspection support for USFDA
• Analyses trends for reasons of late submissions to HA or LP and Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented
• Case information received by the local PV and by global intake teams is registered, in the PV Database according to the case management SOP.
• To ensure follow up to ICSRs is performed according to WIN, and when applicable to supervise the team responsible for outbound calls during which sensitive cases are medically documented
• To ensure the local requirements which are configured in the safety database, for automated and manual distribution are accurate for their Health Authority and local partners
• To drive business improvement for the tasks in collaboration with the involved staff and provide input to the updates of quality documents
• To automate the case intake for all sources IN US
• Responsible for USFDA HA inspections and US country PV audits for case management related activities and other activities under PV ops scope
• To design a Hub case intake oversight approach in alignment with global expectations
• To identify outsourcing opportunities and lead the transfer of knowledge to the vendor

KEY WORKING RELATIONSHIPS

• Work closely with CHC country PV team members
• It requires experience in managing complex issues in a global environment.
• This role will be the key contact point for countries and regions for all topics related to case quality & submissions.
• This position requires multiple interfaces with partners and customers within and outside of the Company this includes Regulatory, PV quality and compliance

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Education

• Pharm D or HCP or Equivalent with at least 8 years’ experience in PV case management activities
• Knowledge of USFDA PV Regulations
• Knowledge of International Regulatory requirements, thorough knowledge and experience in all aspects of Pharmacovigilance impacted by ICSRs, working knowledge of computer systems and data processing

Required knowledge and/or experience

• Successfully managed case management teams
• Experience in case quality check and monitoring of cases in the workflow
• Pharmacovigilance with significant involvement in case management
• Experience in submission-related activities in accordance with USFDA guidelines
• Regulatory expertise of the Health Authority they will submitting to
• Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment
• Strong project leadership experience in a global environment; ideally including having led system or process implementation initiatives
• Strong interest and ability to understand case relevant data, develop processes, including re-engineering of work flows and implementation of IT systems
• Participate in audit/inspections including preparation and interviews

Language skills

• Fluent spoken and written English

Cultural traits / P2W Behavior

• Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions
• Judgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete
• Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop self
• Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results
• Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation
• Role model our 4 values: teamwork, integrity, respect, courage
• Interpersonal relationships - treating others with courtesy, sensitivity, and respect.
• Required Leadership Competencies
• Business Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business results
• Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence
• Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
• Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level
• Take action and don’t wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward
• Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interests
• Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests

Key Dimensions

• Good interpersonal and negotiator skills
• Strong decision-making skills
• Leadership, Teamwork and Management skills;

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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.

#GD-SA
#LI-SA

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.