Product Safety Associate

Merz Group•Burlington, ON

8d•Hybrid

About The Position

This role is located in our corporate office in Burlington, Ontario and requires 3 days per week in the office. Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we’re embarking on a transformative journey, blending time-honored traditions with exciting new products. 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 with 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! #IAmMerz Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Product Safety Associate is responsible for supporting and managing Product Safety activities at Merz Pharma Canada Ltd. This individual may assist upper management in establishing and maintaining all Product Safety functions, in accordance with Health Canada, FDA and European guidelines and regulations, governing pre- and post-marketing vigilance for all Merz Therapeutics products (drugs and biologics). A safety database SME responsible for all tasks related to the collection, processing, follow-up, and post-market regulatory reporting of all adverse events and pregnancy reports for all Merz Pharma Canada Ltd. marketed and investigational products.

Requirements

Bachelors degree in a science or healthcare-related field required.
At least 2-3 years pharmacovigilance experience within the pharmaceutical or device industry required.
Excellent knowledge of regulations governing clinical safety, and pharmacovigilance required.
Working knowledge of MedDRA coding conventions to ensure proper coding of medical terms as well as a working knowledge of the WHO Drug Dictionary required.
Highly effective communication skills (written and oral) which are concise, accurate and business appropriate required.
Good understanding of pharmaceutical research and development process required.
Strong knowledge and understanding of medical terminology and clinical/medical information.
Prior safety database experience required.
Ability to run accurate database searches to answer basic queries as required.
Demonstrated comprehensive understanding of product labelling and Instructions for Use required.
Current knowledge of drug and biologic reporting regulations worldwide required.
Able to continue day-to-day departmental activities in absence of direct management required.
Strong interpersonal, teamwork and organizational skills required.
Ability to function in an environment of rapidly changing priorities with the ability to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
Ability to act independently and to take initiative as well as work within a team.
Self-starter, able to work with a high degree of independence.
Demonstrated critical thinking and problem-solving skills

Responsibilities

Ability to independently analyze and accurately process adverse event reports daily from all sources, for all types of products. This includes an ability to provide an initial assessment of complex medical information and relevant lab results, and the ability to enter the report in the safety database, write comprehensive narrative summaries, and conduct follow-up for all types of products.
Responsible for the review of the scientific literature search results to identify potential reportable adverse event reports that will need to be processed and submitted to Health Canada.
Ensures on time submission of individual AE and SAE case reports to worldwide regulatory agencies, partners, and affiliates in accordance with applicable regulations and agreed timelines. Ensures that Merz Therapeutics Canada obligations with respect to Safety Data Exchange Agreements (SDEAs) are fulfilled in an appropriate and timely manner.
Assists with internal and external requests for safety data. An expert user of the safety database is responsible for working with Global Product Safety, IT and the safety database vendor to solve problem and suggest database improvements as needed/required. Also responsible for generating database outputs, including those to be used for submissions and signal detection.
Works closely with the Product Safety Officers to obtain medical review and assessment on individual AE case reports. Maintains general knowledge of signals, trends, and closely monitored events. Communicates any potential safety issue appropriately. Able to make a preliminary clinical judgment regarding whether or not an individual report is expected/listed or unexpected/unlisted as per the Canada Product Monograph, as well as, whether or not an individual case would likely require Health Canada submission.
Able to run accurate queries and provide standard outputs of the data from the safety database, if requested. Performs searches of the safety database for internal compliance or other ad hoc queries, as required.
As assigned, performs monthly reconciliations with partners/affiliates, Medical Information and QA.
Assists in development, review, and implementation of Product Safety working practices, standard operating procedures (SOPs), or guidance documents to ensure compliance with international regulations governing clinical safety, and pharmacovigilance for adverse event reporting.
As assigned, provides training regarding AE reporting to sales representatives, other employees and contractors/vendors in their obligations regarding adverse event reporting. May assist with orientation/mentoring of new Product Safety staff.
Participates in all internal and external audits, as needed.
Represents Product Safety Canada on the global project level, as required by Global Product Safety.
As assigned, works with Canadian team / Global colleagues to ensure applicable Canadian Annual Safety Reports are addressed and on-time.
As assigned, assists with monitoring Health Canada Database, for safety data for Merz Tx products that were not yet reported to Merz or captured in our Merz Safety Database. As assigned, assists with monitoring of Health Canada Database for potential safety signals reported for Merz Tx products.
Other duties as assigned.