Medical Safety Head, PV (CHC)
Location: Bridgewater, NJ, USA | Industriepark Höchst, Frankfurt, DE | Le Lab 157, Neuilly Sur Seine, FR
Remote Work: Hybrid
Travel Expected: 25% - 30% (domestic & 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.
Under the supervision of the Global Head of Consumer Safety, the Medical Safety Head (TAH) provides PV expertise, leadership, mentorship, and supervision of involved Medical Safety team members and CHC-PV personnel assigned to the respective organization to ensure appropriate assessment of Safety information related to assigned CHC products.
MSH oversees compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables which include; Scheduled Reports, Ad Hoc Reports and Signal Management. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents.
This is accomplished through: Employee recruitment, development and evaluation; cross-functional communication; and application of in-depth regulatory/safety knowledge; manage the strategic messaging and safety profile of our products provided in all deliverables; leading complex projects; Insuring accurate and timely analyses and assessments of safety data for all deliverables.
Management of Global Safety Leads (GSL), Signal & Risk Management Lead, PV Scientist(s) and administrative assistants
Ensure that the Medical Safety objectives are achieved, and compliance goals are met
Oversee safety strategies, decision-making, and escalation of issues
Ensure alignment of Medical Safety objectives, safety strategies and issue escalation with PV
Oversee continuous evaluation of safety and benefit risk assessment activities and strategies for the Medical Safety
Deputize for the Consumer Safety Head if required
Internal and external safety expertise:
Function as a core member of the safety governance
Support QPPV and Affiliates Head as required
Set medical, scientific and PV standards for the Medical Safety
Provide PV expertise within the Company
Key Networking Relationship of Global Sub-Category Head and Their Team
PV representative to Medical Safety review committee for strategic portfolio determination
Interfacing with cross-functional groups and with external companies and regulatory authorities
Interact with clinical development, regulatory, preclinical, labeling, clinical operations, medical writing, legal, medical affairs (or others) and Review and Governance committees.
Ensure appropriate and standardized communication regarding product safety assessment between GSLs and other functions including Medical Affairs, Country Leads and Regional Heads
M.D. Degree, Board Eligible or equivalent in relevant clinical specialty
Additional qualification in management is helpful.
Required knowledge and/or experience
12+ years of experience in PV and/or relevant medical field, including a minimum 5 years of international pharmaceutical activities (such as Research & Development, Medical affairs).
5+ years of Management experience in matrix organization.
Proven proficiency in organizational and planning capabilities is desired
Excellent knowledge of global PV and medical safety, including risk management and signal detection
Interaction with key regulatory agencies, submission experience, experience in post-marketing and clinical development PV
Experienced in people management with proven proficiency in organizational and planning capabilities
Demonstrated leadership ability including within cross-functional team environment
Excellent clinical judgment, teamwork and interpersonal skills
Fluent spoken and written English
An Additional language is desirable
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.