Associate Principal Scientist, Post Market Safety, L'Oréal Research & Innovation
About the role
The Post Market Safety (PMS) group at L'Oréal Research & Innovation (R&I) has direct responsibility for cosmetovigilance and pharmacovigilance operations for the United States, collaborating closely across the Americas Zone. We are seeking an Associate Principal Scientist to independently lead technical and process-related activities within the Post-Market Safety group.
Responsibilities
Perform expert medical assessments of adverse event case reports for seriousness, causality, and expectedness, maintaining the integrity of our vigilance operations.
Conduct global post-marketing safety analyses requested by cross-functional partners (Marketing, Product Safety, and Global PMS), translating safety data into strategic insights.
Lead the quality review and timely submission of all OTC drug and cosmetic MedWatch reports to the FDA, managing correspondence with partner companies and vendors.
Query vendor databases to review adverse events and ensure appropriate follow-up. Notify relevant partner contacts and manufacturing sites of potential quality-related complaints.
Serve as a point of contact for case-related inquiries from the L'Oréal Call Center and Global PMS team. Prepare patch test letters and kits for physicians upon request.
Maintain accurate documentation, recordkeeping, and archiving of all safety-related information in compliance with global SOPs.
Mentor and train junior members of the PMS team and provide post-marketing safety training for new employees across the organization.
Continuously review and update standard operating procedures (SOPs) and work processes to ensure agility and compliance.
Requirements
A highly organized medical or pharmaceutical professional with a meticulous eye for detail and a deep understanding of safety regulations.
Education: Pharm.D., D.Ph., or a Nursing degree is preferred. A working knowledge of basic medical terminology is required.
Experience: Minimum of 7 years of relevant experience in case processing and medical assessment.
Profilince in MedDRA coding is required.
In-depth understanding of U.S. Regulations pertaining to adverse event reporting.
Skills & Attributes
Excellent communication (verbal and written) and interpersonal skills.
Demonstrated capability in analyzing, reporting, and documenting complex information with strong attention to detail.
Ability to work independently with minimum supervision in a highly matrixed environment.
Prior people management experience is a distinct advantage.
What’s In It For You
A place for you to leave your comfort zone and grow beyond your potential.
Real responsibility from day 1, there’s no sitting on the sidelines at L’Oréal.
An environment where people of every ethnicity, social background, age, religion, gender and sexual orientation as well as people with disabilities are accepted, can speak up, will thrive and are celebrated!
A place where you can contribute to something bigger!
Many of our brands have societal /environmental causes to make concrete difference.
Competitive Benefits Package (Medical, Dental, Vision, 401K, Pension Plan).
Hybrid Work Policy (3 days in Office, 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, Monthly Mobile Allowance).
Learning and 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.