CHC Case Management Head
Location: Bridgewater, NJ
Remote Work: Hybrid
Travel Expected: ~10% (domestic and international)
Job Type: Full time
About the Job
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
This is a Leadership member of the CHC PV Operations team and reports to the CHC PV Operations Head.
This position includes responsibilities of Case Medical Safety lead
The position is the process owner for case management globally in the Company, accountable for group wide alignment of ICSR management standards.
This position is responsible for providing the strategic vision, planning and oversight on Inbound receipt, assessment & Health Authority submission of adverse events/ICSRs for all CHC PV customers globally and locally.
Responsible for accurate medical assessment of adverse event cases and lead the case medical evaluators team
This position maintains oversight and responsibility for global case processing vendors.
Key Results & Accountabilities
Case Management Responsibilities:
To improve and reinforce globally integrated case management standards, procedures and systems in line with changes in the regulatory environment and best industry practices.
He/She is directly responsible to implement and manage the overall adverse event case processing including but not limited to case management for marketed CHC products, safety medical evaluation, HA reporting, Product Technical Complains (PTC) and management of medical device/drug device combination products.
Directly responsible for case management activities for USFDA, EMA & PMDA authorities.
Responsible to lead and support PV inspection/audit for US FDA, Japan PMDA and EMA
Manage oversight of PV case management activities through internal team leads and a service provider based in India.
To build synergy and partnerships with other global PV departments, PV teams within the affiliates/regions and science hub as well as with the external partners;
Ensure the vendors and distributors are qualified, high performing and motivated to accomplish the aligned objectives.
Ensure proper planning and execution of the changes approved by upper management with appropriate funding. This includes the management of external vendors and budget tracking for case management activities.
He/She contributes to safety management activities in cooperation with CHC Global Pharmacovigilance (GPV), Country PV teams, HA (Health Authorities), partner companies and other functions in compliance with global procedures and local regulatory PV requirements
To systematically evaluate the availability of resources for ICSR management and keep them trained according to global SOP, WIN and user manuals
To be aware of local/regional legal requirements for case management and data privacy that impact the task and generate globally valid operating standards
To drive business improvement for the tasks in collaboration with the involved CRO staff
To solicit local regulatory obligations from appropriate subject matter experts and assess impact to the global standardized process
To represent CHC global case management in all HA inspections and PV audits
Case Management expert leading all discussions involving internal/external stakeholder and Partner company about case management
Case Medical Safety Responsibilities:
He/She will be the Case Medical Safety Lead for CHC
Responsible for case (ICSR) medical safety activities in post marketing & clinical studies of CHC products
Lead the team of Case Medical Safety evaluators and oversee participation of case medical evaluators in safety analysis team for input of contextualized case data into the surveillance process and feedback on data requirements.
Early Identification and management of potentially important product safety issues of CHC products
Ensure essential PV foundational supported needed from case management to enable timely and proactive safety signal detection and risk management
Ensure availability of immediate safety alert reports, which enables Global Safety Officers to monitor the safety of our products and respond to inquiries from Health Authorities
Ensure High quality medical assessment of all adverse events
Responsible for appropriate training of all CMSE contributors
Key Working Relationships
This role will be the key contact point for countries and regions for all topics related to CHC ISCR’s.
This position requires multiple interfaces with partners and customers within and outside of the Company this includes TAH, PBRER, Regulatory, digital and commercial partners with we have pharmacovigilance agreements.
It requires experience in managing complex issues in a global environment.
PharmD or HCP equivalent with 10+ years of pharmacovigilance case management experience OR MD with 8+ years of experience in pharmacovigilance case management.
People management experience is preferred.
Knowledge of global and local PV regulations
Strong knowledge of the case management and medical safety evaluation in clinical trial and marketed products
Knowledge of PV safety system management. Experience with LSMV is preferred.
Appropriate experience of periodic reports, safety evaluation, risk management and communication with HA.
Knowledge of Project management or experience
Knowledge of PV Database and relevant PV tools used for PMDA
ICSR evaluation (seriousness, relatedness, unexpectedness and MedDRA coding) and HA reporting using PV safety system
Strong interest and ability to understand case relevant data, develop processes, including re-engineering of work flows and implementation of PV IT systems
Strong project leadership experience in a global environment; ideally including having led system or process implementation initiatives
Skill of fluent verbal and writing communication in English
Ability to manage and lead transversal meetings and small to moderate size groups and take appropriate decisions
Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment
Proficiency in Microsoft applications (Word, Power Point, Excel)
- Fluent spoken and written English
Cultural Traits / P2W (Play to Win) Behavior
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
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
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
Role model our 4 values: teamwork, integrity, respect, courage
Required Leadership Competencies
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
Business Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business results
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
Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results
Interpersonal relationships - treating others with courtesy, sensitivity, and respect.
Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation
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
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
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
Leadership, Teamwork and Management skills;
Good interpersonal and negotiator skills
Strong decision-making skills
Medical knowledge with clinical experience
Pursue Progress, Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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.