Position Title: Senior Scientist II, Post Market Safety & Cosmetovigilance
Location: Clark, New Jersey (Hybrid)
Department: Post Market Safety & Cosmetovigilance
Reports Into: Manager, Post Market Safety & Cosmetovigilance
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.
The Senior Scientist II in Post Market Safety & Vigilance is responsible for independently conducting technical process-related activities in the Post-Marketing Safety group for all Over-the-Counter (OTC) drugs and cosmetic products sold in the USA. The Senior Scientist II will work together with the Product Safety Evaluation group in managing the safety assessment of products, including review of individual and aggregate adverse events.
As a Senior Scientist II in Post Market Safety & Vigilance, your main responsibilities are:
- Perform medical assessment of adverse event case reports for seriousness, causality, and expectedness
- Perform global PMS analysis requested by other functions including Product Safety Evaluation, Marketing, Global PMS team, and to ensure compliance with global SOPs
- Ensure the completion, quality review and submission of all OTC Drug & Cosmetic MedWatch Reports to FDA, correspondence with partner companies/vendors as required, while maintaining appropriate recording and archiving of information.
- Provide prompt queries of vendor’s database to review all adverse events received, notify appropriate partner contacts, review for potential quality-related complaints, notification of manufacturing sites, while maintaining appropriate recording and archiving of information.
- Ensure preparation of patch test letters/kits for physicians when requested and follow-up the results once the investigations are performed and completed.
- Serve as a point of contact regarding case inquiries from the L’Oréal Call Center or global PMS team including database queries and case corrections.
- Provide PMS training to new employees
- Review/update standard operating procedures (SOP) and work processes (WP) as needed
To Succeed In This Position, you have:
- Pharm.D., R.Ph., Nursing degree or terminal degree (PhD) in closely related field preferred with case processing & medical assessment experience and a working knowledge of basic medical terminology required
- Minimum of 5 years relevant experience required
- Experience in cosmetovigilance, pharmacovigilance, or post-market safety strongly preferred
- Experience in MedDRA coding.
- Understanding of US Regulations pertaining adverse event reporting is required.
- Excellent communication (verbal, written) and interpersonal skills required.
- Well organized while handling multiple projects simultaneously.
- Demonstrated skills in analyzing, reporting, and documenting information with strong attention to detail.
- Ability to work independently with minimum supervision in a matrix environment.
- Must have authorization to work in the United States on a full-time, permanent, ongoing basis, without the need for legal sponsorship now or in the future
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
Don’t meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you’re excited about this role but your past experience doesn’t align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles!
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.
Our Safe Together Plan: Your safety is our highest priority. We will proceed with caution and adhere to enhanced protection standards to ensure our sites are safe for all employees. We must all operate with the shared responsibility for each other’s health & safety in mind.