SUMMARY

The Intake and Submission Manager (ISM) will be responsible to oversee the In- and Outbound processing of cases collected locally, collaborating with all entities (affiliates, partners, CSU, vendors, and core processing sites) involved in this activity.

The main objective of the Intake and Submission Manager is to ensure that:

• Case information received by the local PV and by global intake teams is registered, in Artemis or the PV Database according to the case management SOP.

• 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.

The ISM will have:

• To oversee the resources outside GPV involved in this activity in collaboration with the PV Affiliate Relation function

• To ensure the local/regional requirements for automated and manual distribution are collected and maintained

• To systematically evaluate the availability of resources for this task 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 staff and provide input to the updates of quality documents

• To generate user requirements for technology enhancements for inbound processing and lead the implementation from a business perspective

• To solicit local regulatory obligations from appropriate subject matter experts and assess impact to the global standardized process.

• To implement a systematic regular oversight of the intake and submission activities performed by the vendor and implement quality performance and compliance metrics for the associated tasks

• 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

MAJOR DUTIES & RESPONSIBILITIES

• 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 systematically evaluate the availability of resources for this task and keep them trained according to global SOP, WIN, and user manuals

• To have a full understanding of the local 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 staff and provide input to the updates of quality documents

• To be the intake and submission SME for the projects requiring such expertise (i.e. new tool, new regulation, acquisition, partners etc.…)

• To be the intake and submission SME for audit and inspections

• To provide exhaustive business needs to the IT function for them to generate user requirements for technology enhancements for inbound case processing.

• To identify when needed an oversight for the activity for intake and submission when done by a vendor or by another department, and build such oversight process with documentation and tracking.

• To identify outsourcing opportunities and lead the transfer of knowledge to the vendor

• To design a Hub case intake oversight approach in alignment with global expectations

• 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

QUALIFICATIONS

Knowledge And Skills

• Minimum 4 years experience in pharmacovigilance with significant involvement in case management

• Ideally a career path combining experience in local offices and corporate functions

• Regulatory expertise of the Health Authority they will submitting to

• Strong interest and ability to understand case relevant data, develop processes, including re-engineering of work flows and implementation of IT systems

• Strong project leadership experience in a global environment; ideally including having led system or process implementation initiatives

• Successfully managed case management teams

• Ability to manage and lead transversal meetings and small to moderate size groups and take appropriate decisions

• Ability to manage a global matrixed virtual teams and ensure productivity, efficient organization and communication

• Participate in audit/inspections including preparation and interviews

• Fluent English

Formal Education And Experience Required

• Registered Nurse, Pharmacist, PharmD or other advanced medical degree

• 6+ years of experience in Global Pharmacovigilance; project management or related experience

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

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.

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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.