CHC - PV compliance, Quality Manager (H/F)
- Pharmaceutical / Biotech
CHC - PV compliance, Quality Manager (H/F)
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Sanofi, a global healthcare leader
Life is a health journey, with its ups and downs. Every day at Sanofi France, 25,000 men and women join forces with passion to transform scientific progress into therapeutic solutions so that everyone can live their life to the full.
Faced with health challenges and the complexity of diseases, Sanofi’s mission can be summed up as preventing, treating and curing diseases.
In France, Sanofi provides over 400 drugs, vaccines and healthcare products, including 17 vaccines and over 200 drugs of major therapeutic interest.
Its wide range of products makes Sanofi a major player in French healthcare: 1 in 6 boxes dispensed in French pharmacies is a Sanofi product.
Sanofi is also committed to public health. Its vaccines protect children, adolescents and adults against more than 11 infectious diseases.
Every year in France, 8 million people are vaccinated using Sanofi vaccines.
About the opportunity
We are looking for our Pharmacovigilance Compliance and Quality Manager within Sanofi Consumer Health Care.
Your contribution will be key in maintaining oversight of Sanofi CHC Quality PV system and ensuring inspection readiness.
About growing with us:
In this role, you will :
Ensure a sustainable compliant and robust quality system meeting all regulatory and legal requirements related to PV activities.
Create, enable and maintain a PV quality system which mandates from global, to country level a state of control on monitoring and tracking systems with regards to all pharmacovigilance activities.
Identify potential risks of non-compliance and establishes and oversees improvement programs to mitigate the risks
Ensure that the PV organization is inspection-ready and supports preparation, conduct and follow-up of inspections and audits requiring PV input
You will have to :
Conduct Routine Compliance activities and tasks related to ICSR, PSR submissions to Health Authorities
Run compliance investigations and Root Cause Analysis,
Identify potential critical and major systemic deviation
Identify Trends during ongoing investigations and as part of retrospective reviews.
Participate to the remediation of compliance gaps
Manage PV Audit and inspection readiness:
Permanent inspection preparedness and readiness in anticipation to Regulatory inspections and audits.
Organization of appropriate support for the preparation, conduct and follow up of regulatory inspections impacting PV until closure.
Management and coordination of Business Partners and Global PV Service Providers audit activity
Regular oversight of audit/inspections PV related Corrective and Preventive Actions (CAPAs)
External relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV inspections regulations/practices and benchmark on recurrent inspection PVfindings.
PV Retrospective QA checks and deviations management :
Ensure oversight and controls on PV systems (activities e.g. Individual Case Safety Report management) or PV output (PSUR, etc
Ensure consistency in quality measures
Ensure a global system to track and monitor investigation of all identified quality gaps, quality risks.
Perform trend analysis on QAs results and deviations and analyze effectiveness of corrective/preventative action and re-adjust the measure
Quality Vendor Oversight:
Implement a global vendor qualification standards and processes to track vendor assessments for PV and oversee the level of quality of their deliverables
Quality Documents & training operations:
Conduct the definition of GPV standards to ensure the preparation and maintenance of Quality documents (QDs)
Ensure timeliness and quality of PV Quality documents in the Electronic Document Management System
Ensure process is in place to maintain the GPV QD Training Matrix and the delivery of training of the respective QDs
Ensure PV ebinder is appropriately maintained to allow all PV associates having available CV and Job-description up-to-date for audit or inspection requests
About you :
Scientific background: Pharm D or Master Degree in Human Health Sciences with Minimum 5 years’ experience in managing Pharmacovigilance activities. Experience dealing with audit and inspections would be a plus.
Capability to work under extreme pressure.
Excellent communication skills (oral and written).
Experience in pharmacovigilance and in the field of PV or clinical inspections.
Excellent organizational and planning capabilities.
Ability to work in transversal/cross functional teams.
Excellent teamwork and interpersonal skills.
Organized and detail oriented, efficient time management
Analytic, pro-active and effective problem-solving skills.
About Sanofi CHC Purpose and Aspiration
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 centred 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 Consumer Healthcare company. 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.
We have recently announced an exciting 18-24 month journey to create a fully standalone CHC business (separating the Business Unit from our Pharma company heritage, processes etc), as we target to create the best FAST MOVING CONSUMER HEALTH company, which will require us to retain, attract and grow the best leaders in our industry.
Own your future and make your move:
Contract : Permanent ContractTo be Filled : As soon as possible
Inspire your Journey: what Sanofi can offer you
An international work environment, in which you can develop your talent and realize ideas and innovations.
You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
As a globally successful and constantly growing company, Sanofi provides international career paths as well.
Your applicationAre you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a team to serve healthier, fuller lives ? Then send us your online application including cover letter and CV in English
This is our Sanofi. Discover yours: https://www.sanofi.com/en/careers/
Meet the Sanofi team
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