Risk Management Expert- REMOTE
Company: Sanofi
Location: Bridgewater
Posted on: June 26, 2022
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Job Description:
Job Summary:The RME provides risk management expertise for
Sanofi products, especially for investigational products and/or
high-risk profile marketed products and/or with complex regulatory
/ safety situations, elaborating risk management strategy and
managing external interfaces with partners and/or regulators and/or
other experts. He/she has a mentorship role for new RMEs or RMEs
with less experience or fellowships. The RME has an excellent
capability, leadership and autonomy carrying out the missions and
addressing major challenges detailed here-after:Provides expertise
& leadership in pre and post marketing risk management for
investigational and marketed products supporting global, regional
and local teams, aiming at patient safety.Develops the global risk
management strategies to optimize the benefit-risk profile, for
initial submissions or marketed products in coordination with
relevant functions (e.g. pharmacovigilance, epidemiology, medical,
regulator, marketing/commercial) interacting with regulators or
external experts, and ultimately obtains endorsement from
appropriate senior committee(s)Ensures development of RMP document
(regulatory document of submission dossier) leading a
cross-functional team (eg, RMP task force satellite of the product
submission task force)Supervises globally the appropriate
implementation of risk minimization activities beyond routine for
concerned products, using a validated electronic tracking system to
monitor the local implementation data in collaboration with a cross
functional team (regulatory, medical, pharmacovigilance and
marketing/commercial)Manages external interfaces with partners for
investigational products and/or marketed productsParticipates as
subject expert matter (SME) for risk management process to
inspections/ auditsOperates an oversight of the outsourced RMP
related activities for concerned products or territories, as
applicableActs as primary contact or subject matter expert for the
RMP Team on specific topics (e.g., SDEA or electronic tracking
system or RMP related quality documents)Delivers RMP trainings to
internal and/or external audienceThe RME located in the US has a
specific role of primary interface/liaison with the US Safety team
dedicated to Risk Evaluation Mitigation Strategy (REMS) of products
under development and marketed products, in order to support and
align the product strategy between Europe and US, taking into
consideration the American specificities. In addition, this RME
addresses any RMP related questions raising from America's regions,
and vice versa convey the global RMP Team any specific requirements
of the FDA or the Latin American Agencies, that would impact on RMP
activities more globally.Knowledge And Skills:Risk management
Excellent understanding of the concept of risk associated with the
use by patients of a medicinal product/medical device, in its
clinical, individual patient health, public health and regulatory
dimensions Strong knowledge of international regulatory and
scientific environment in risk management (eg, international
guidelines, RMP template)Expertise in pre and post marketing risk
management, including risk assessment and risk minimization
activities with ability to propose strategies adapted to the
product and the environmentExpertise for supervising global and
local implementation of risk minimization activities, particularly
risk minimization activities beyond routine (e.g, educational
material or controlled dispensing), and for analyzing effectiveness
results of these activities in order to adjust the risk
minimization strategy (as needed)Excellent networking and
collaboration skills to interact transversally with numerous
functions involved in RMP-related activities, demonstrating
leadership within a cross-functional team, as well as supporting
local safety teams for developing local RMP documentsPersonal
skills:Ability to share risk management knowledge, as a SME in that
field Ability to manage internal/external stakeholders with
courtesy and respectAbility to present the risk management strategy
to various internal committeesAbility to discuss the risk
management strategy with regulators (e.g. Agency
meetings)Demonstrates initiative and capacity to work under
pressure, to contribute to solutions of safety crisisStrong ability
to manage competing priorities and timelines for numerous products
in parallelFluent in EnglishFormal Education:M.D., Pharm D, PhD or
MPH Degree in pharmacovigilance preferred and/or relevant medical
field (e.g., clinical development) and/or regulatory area and/or
toxicologist and/or pharmacoepidemiology Experience
requiredSignificant experience (including industry experience) with
a working knowledge of drug safety and risk management, and
understanding of life-cycle product, and specific knowledge of
international RMP regulatory guidelinesWorking knowledge of common
data processing software (i.e., Excel, PowerPoint, Word) or
internal software's and database systemsTechnical skills for
understanding document management systems including assembly of
documentRisk management expertise for projects/products: Provides
expertise and support to internal or external team representatives
for elaboration of the company core risk management strategy
(CC-RMS) for products at all stages of the product life-cycle
(development and post marketing phases). In particular:Provides
expertise in risk management including: risk characterization and
impacts of risks, risk assessment, risk minimization and
measurement of the effectiveness of risk minimization
activities.Determines the appropriate risk minimization measures in
postmarketing setting to ensure patient safety in light of
benefit/risk assessment in coordination with relevant functions
(pharmacovigilance, epidemiology, medical, regulatory), including
at the local level. It encompasses interface with external experts
as needed. Obtains endorsement of CC-RMS by appropriate senior
committeesEnsures development of RMP documents leading a
cross-functional team in frame of RMP Submission task force and/or
RMP Working GroupEnsures consistency/alignment of product CC-RMS
across countries - Provides support to local safety teams in
developing and validating local RMP as appropriate - Provides
contribution to Health Authorities' questions, and participates to
meetings and interacts with regulators to defend/negotiate the
CC-RMS (as needed) - Provides expertise and supports to GSOs on
Development Risk Management PlansSupervision of the implementation
of additional risk minimization measures beyond routine (aRMMs) for
concerned marketed products:Communicates product CC-RMSto
appropriate audienceCreates and leads the supervision group
involving transversal functions in charge of global supervision of
implementation of activities, executed and tracked locallyUses the
validated electronic tracking system to validate and supervise
local implementation plansEnsures follow-up of effectiveness of
minimization activities, analyzes deviations and sets up adequate
action plan for adjustment of the RMS as neededMaintains a high
level of quality and knowledge on RMP-related activities and ouputs
within sanofi:Communicates and promotes knowledge on regulation
requirements, guidances, recommendations and templates with respect
to risk management - Ensures audits and inspections readiness for
products at all stages of the life-cycle - Ensures risk management
governance process is appliedInternal and external
communication/network: Ensures networking with different internal
stakeholders at global, regional and local levelEnsures appropriate
partners are informed about product RMP-related activities (as per
Safety Data Exchange Agreement)Ensures with medical affairs
colleagues appropriate selection of vendors and establishes
communication with external contract organizations developing
minimization tools, with feasibility survey and/or user testing
when neededSets up or participates to medical/scientific expert
meeting (internal/external) to determine adequate product
CC-RMSAdvocates risk management to internal and/or external
stakeholdersRisk management training and mentoring:Ensures training
of GPV staff in risk managementCollaboration and
knowledge/experience sharing within RMP Team or GPVMentorship of
new RME comers or RMEs with less experienceProvide external
training as appropriateSanofi 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 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.As a healthcare company
and a vaccine manufacturer, Sanofi has an important responsibility
to protect individual and public health. This position will require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.GD-SALI-SAPDNAt 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.PDN-94ccba3f-af0d-45aa-a7d2-81ca39f0fed6
Keywords: Sanofi, Trenton , Risk Management Expert- REMOTE, Executive , Bridgewater, New Jersey
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