Position Title: Director, Post Market Safety & Vigilance
Location: Clark, New Jersey (Hybrid)
Department: Post Market Safety
For more than hundred years, L’Oréal believes that beauty needs Science. In a world now transformed by digital technology and the emergence of new scientific domains, we are confident in our ability to turn these opportunities into major innovations, closely linked to the new consumer expectations all over the world. Science & Technology are allowing us to invent safe, trustable, sustainable & responsible beauty products and experiences that will change people’s lives.
L’Oréal Research & Innovation (R&I) has continuously invested upstream in its research with a high level of ambition. Our 4 100 L'Oréal R&I people are talented and highly skilled, located in major markets, working in a cooperative way, open to the world.
The Post Marketing Safety group has direct responsibilities for cosmetovigilance operations for the United States and close collaborations across the Americas Zone and provides strong strategic leadership across the Americas Zone.
The Director in Post Market Safety & Vigilance is responsible for leading a team of technical experts in the collection, detection, assessment, and monitoring of spontaneous reports of human adverse events observed from use of Over-the-Counter (OTC) drugs and cosmetic products, in full alignment with Global Corporate strategy and meeting all US FDA regulatory requirements.
As a Director in Post Market Safety & Vigilance, your main responsibilities are:
- Be the strategic and operational leader of a team of highly skilled technical professionals within the Post-Market Safety organization supporting the Americas while continually encouraging 100% employee engagement.
- Provide direction and set objectives for the team within the Post-Market Safety function of SRCM Americas.
- Provide oversight and training to ensure proper handling of post-marketing data (health related contacts).
- Ensure accurate completion of medical assessments of case reports for seriousness, causality, and expectedness.
- Provide oversight of expedited case report preparation/tracking for regulatory submissions.
- Responsibility for safety signal activities by reviewing aggregate data, monitoring trends of reporting for Americas zone, in close interactions with Global Post-Marketing Safety teams.
- Perform post-market safety analysis on L’Oréal marketed products as requested by other stakeholders such as Product Safety, Development Labs, and Marketing.
- Lead for Americas zone electronic systems interface, communicate function needs for upgrades, facilitate meetings with stakeholders.
- Facilitate communication and collaboration with regional PMS teams within America’s zone, provide guidance in Monthly Reporting process, Medical Assessment training, or support with managing case backlog of Medical Assessments as needed.
- Assisting with implementation of continual operational improvement including writing/revising SOPs, and Work Practices.
- Provide technical expertise to L’Oréal Consumer Care Center, Product Safety, Regulatory, and Legal groups.
- Responsible talent development of team for continual growth of functional expertise and skills.
To Succeed In This Position, you have:
- PhD., Pharm.D., Nursing degree or closely related medical field (required)
- Minimum of 10+ years of progressive and relevant experience (required)
- People management experience (direct reports) required
- Skilled professional who can independently apply, on a broad basis, existing theories, principles, and concepts within the field of Post-Market Safety/Cosmetovigilance/Pharmacovigilance.
- Understanding of US Regulations pertaining to adverse event reporting required.
- Demonstrated experience in leading, managing and developing high performing cross-functional and multi-cultural teams.
- Excellent communication (verbal, written) and people skills required, with ability to analyze and summarize complex technical issues and initiatives for key business target audiences.
- Demonstrated skills in analyzing, reporting, and documenting information with strong attention to detail.
- Proven leadership skills with a strong results orientation, positive "hands-on" attitude and a sense of urgency to get things done with demonstrated grace and even temperament under pressure.
- Reports directly to head of Americas Safety, Regulatory, Claims, Microbiology and functionally (dotted line) to Global Head of Post-Marketing Safety.
What's In It For You:
- Corporate Short Term Incentives (Corporate Profit Sharing Bonus, Individual Performance Bonus)
- Competitive Benefit Package (Medical, Dental, Vision, 401K, Pension Plan)
- Hybrid Work Policy (Up to 2 Days Work from Home)
- Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!)
- Access to Company Perks (VIP Access to L’Oréal’s Internal Shop for Discounted Products)
- Learning & Development Opportunities (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!)
- Employee Resource Groups (Think Tanks and Innovation Squads)
- Access to Mental Health & Wellness Programs
If you identify yourself in this position, please apply by uploading your resume in a PDF.
The L'Oréal Group is convinced that difference is a deep source of wealth, that allows everyone to grow, to challenge themselves and to go further. We strongly encourage everyone to always dare and never censor themselves. Skills can always be learnt. We will be delighted to exchange with you!
To discover our scientific and technical functions at L'Oréal Research & Innovation, please check our career website : https://careers.loreal.com/en_US/content/ResearchInnovations?3_4_3=128
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email [email protected] Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.