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. 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 p... more details
Pharmacovigilance (PV)Case Management Head
Location: Morristown, NJ
About the Job
We're seeking a vigilant and dedicated professional to fill the position of Pharmacovigilance Case Management Head. If you have a keen eye for detail, a passion for pharmacovigilance regulations, and a commitment to maintaining the highest standards of drug safety, we invite you to apply. Be part of our mission to safeguard public health and make a meaningful difference in the pharmaceutical industry.
At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. 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. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.
Main Responsibilities:
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.
- 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.
- 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 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:
- 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
About You
- 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
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.
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