Product Safety Associate
Company: Disability Solutions
Location: Raleigh
Posted on: October 2, 2024
|
|
Job Description:
Based in the Raleigh, NC Corporate office - Hybrid (in office 3
days/wk)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 Associate is responsible for assisting upper management in
establishing and maintaining all Product Safety functions, in
accordance with FDA, Health Canada and European guidelines and
regulations, governing pre- and post-marketing vigilance for all
Merz Pharmaceuticals, LLC (Merz Therapeutics) products (drugs and
biologics). Responsible for addressing Product Safety project
related administrative tasks. 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 Merz Therapeutics US, including applicable
regulatory reporting for investigational products.Essential duties
and responsibilitiesMajor dutiesDescriptionAdverse Event Case
Processing and OversightAbility 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.Literature review for
AEsResponsible for the review of the scientific literature search
results received from our literature vendor to identify potential
reportable adverse event reports that will need to be processed and
submitted to FDA. Conducts periodic and timely reviews of
literature reports to evaluate for AE and SAE cases to be entered
as case reports. On Time submission of AE ReportsEnsures 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 US obligations with respect to Safety Data Exchange
Agreements (SDEAs) are fulfilled in an appropriate and timely
manner. Safety database subject matter expert (SME), assists with
internal and external request for safety dataAn expert user of the
safety database is responsible for working with Global Product
Safety, IT and the safety database vendor to problem solve and
suggest database improvements as needed/required. Also responsible
for generating database outputs, including those to be used for
submissions and signal detection.Interpretation of individual AE
reports and safety dataWorks 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 US label, as well as, whether or not
an individual case would likely require FDA submission.Safety
database searching 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.Reconciliation of
safety dataAs assigned, performs monthly reconciliations with
partners/affiliates, Medical Information and QA.Review and Update
of Departmental documentsAssists 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.Provides
training regarding AE reportingAs assigned, provides training 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.Audit
SupportParticipates in all internal and external audits, as
needed.Interacts with and supports Global SafetyRepresents US Tx
Product Safety on the global project level, as required by Global
Product Safety. US PADER reports / Annual Safety Reports As
assigned, assists with annual PADER reports for US Tx local
products and works with Regulatory to ensure the on-time submission
of the report to the FDA.FAERS (FDA) Database monitoringAs
assigned, assists with monitoring USA FDA FAERS, for safety data
for Merz Tx products reported to health authority (HA), that were
not yet reported to Merz or captured in our Merz Safety Database.
As assigned, assists with monitoring of FAERS for potential safety
signals reported for Merz Tx products by HA.Other duties as
assigned Job related qualifications/skills Education- Bachelor's
degree in a science or heath care-related field required
Professional experience- At least 1-3 years pharmacovigilance
experience within the pharmaceutical or device industry required.
Knowledge, skills and abilities (incl. languages)- 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.- Requires
highly effective communication skills (written and oral) which are
concise, accurate and business appropriate.- Good understanding of
pharmaceutical research and development process. Strong knowledge
and understanding of medical terminology and clinical/medical
information required.-Prior safety database experience required.
Ability to run accurate database searches to answer basic queries
as required. -Demonstrates comprehensive understanding of product
labeling and Instructions For Use required.Knowledge of methods-
Maintains current knowledge of drug and biologic reporting
regulations worldwide. - Able to continue day to day departmental
activities in absence of direct management. Personal skills- Strong
interpersonal, teamwork, organizational skills. - 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 required.Don't meet every single
requirement? Studies have shown that women and people of color are
less likely to apply to jobs unless they meet every single
qualification. At Merz Therapeutics we are dedicated to building a
diverse, inclusive, and authentic workplace, so if you're excited
about this role but your past experience doesn't align perfectly
with every qualification in the job description, we encourage you
to apply anyways. You may be just the right candidate for this or
other roles. Recruitment Note: Merz Therapeutics only sends emails
from verified "merz.com" addresses and never asks for sensitive,
personal information or money. If you have any doubts about the
authenticity of any type of communication from, or on behalf of
Merz Therapeutics, please contact Therapeutics.HR@merz.com
Keywords: Disability Solutions, Jacksonville , Product Safety Associate, Other , Raleigh, North Carolina
Click
here to apply!
|