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At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference.
As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth and the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.
If you‘re looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we’re looking for YOU! #IAmMerzTx
Are you ready to galvanize a team around a culture of care, putting patients first to spark change?
The full-time Associate is responsible for supporting activities for product safety and quality assurance for drug local drug products including processing incoming product complaints (both adverse events and quality complaints), quality investigations, SOP revision and management, and training of employees on processes. This individual acts as the Deputy Local Pharmacovigilance person.
Description
Safety and Quality Complaint Management
• Intake and processing safety cases locally
• Entering quality cases into the Global database
• Performing follow-up activities with clinics to collect additional case information as necessary
• Case reconciliation activities with safety partners and other teams
• New hire complaints and adverse events training
• Reporting serious safety cases to health authorities
• Managing the Health Canada safety case search process and ATIP request process
• Replacing customer product as needed
• Filing case documents
• Group inbox monitoring, filing and clean up
• Liaising with key safety teams globally within Merz
• Act as deputy local pharmacovigilance person
Quality Assurance Tasks
• Processing product returns
• Product receiving and release activities
• Replacing customer product as needed
• Writing and/or revising Standard Operating Procedures, guiding and training other departments on company SOP process
• Corrective and Preventive Action (CAPA) activity implementation, reporting, and close out
• Assist with internal corporate audits and authority inspections
• Assist with local recall activities
• Assist with 3rd party vendor qualification activities and inspections
• Assist with monitoring, tracking, and investigating deviations
• Assist with electronic document management system implementation and training
• Working with regulatory officials during quality inspections and support all Merz sites globally with any requests for information from an authority inspection
• Liaising with key quality teams globally within Merz
Other duties as assigned
• Staying up-to-date on all SOP reading/training requirements
• Administrative tasks as necessary
Education
-Bachelor’s degree (Health Sciences, Life Sciences, Kinesiology, Science, Biology, Chemistry, Nursing, Pharmacy or related field) Required
Professional experience
–3 to 5 years experience with pharmacovigilance Required
-3 to 5 years experience with quality assurance activities Required
Knowledge, skills and abilities (incl. languages)
-Thorough understanding of pharmacovigilance and ability to communicate with Medical and Regulatory personnel Required
-Must be proficient in Microsoft Office applications including Word, Excel and PowerPoint Preferred
-SAP experience Preferred
-Ability to maintain strict patient and information confidentiality Preferred
