Product Safety Lead

Job Description

Product Safety Lead:
On behalf of our Pharmaceutical client, Procom is searching for a Product Safety Lead for a 6-month contract. This position is a hybrid position with 3 days onsite at our client’s Raleigh, North Carolina office.

Product Safety Lead - Job Description:
The Product Safety Lead is responsible for overseeing the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials, as well as adverse events of interest (AEIs) and pregnancy reports for Merz Aesthetics' marketed and investigational products. This role involves processing reports for medical devices, cosmetics, and OTC products, ensuring compliance with global safety regulations.

Product Safety Lead - Responsibilities:
• Independently analyze and process adverse event reports for medical devices, cosmetics, and OTCs
• Participate in clinical project teams and manage SAE processing during clinical studies
• Ensure timely submission of AE and SAE reports to global regulatory agencies
• Evaluate individual case reports and conduct medical reviews
• Execute literature reviews to identify safety signals
• Utilize safety databases for data entry and report generation
• Assist in developing and updating departmental documents for compliance
• Provide training on adverse event reporting to various stakeholders
• Support internal and external audits
• Collaborate with global functions and support regional safety staff

Product Safety Lead - Mandatory Skills:
• Thorough knowledge of safety reporting for clinical trials and marketed products
• Experience with validated safety databases and coding systems
• Ability to work collaboratively in a fast-paced environment
• Strong knowledge of FDA and EU regulations
• Strong organizational and project management skills
• Strong verbal and written communication skills
• Bachelor’s degree in a science or healthcare-related field, or RN/PharmD

Product Safety Lead – Nice-to-Have Skills:
• Direct healthcare experience with injectable products
• Knowledge of document management systems
• Experience in vendor management
• Relationship-building skills
• Problem-solving skills

Product Safety Lead – Assignment Length:
This is a 6-month contract. 

Product Safety Lead - Start Date:
ASAP.

Product Safety Lead - Assignment Location:
Raleigh, North Carolina, United States. Hybrid with 3 days in office.