Associate Director, Pharmacovigilance Scientist
Company: Moderna Theraputics
Location: Cambridge
Posted on: May 13, 2022
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Job Description:
The Role:
Join Moderna Therapeutics' enthusiastic and collaborative team and
make a significant impact on the overall success of our novel
messenger RNA approach to drug development. By joining our Clinical
Safety Science Team, the Associate Director, Clinical Safety
Scientist is responsible for performing core pharmacovigilance
activities in partnership with the Global Medical Lead by
supporting the process for signal management activities and
analyses, aggregate report contributions, responding to safety
questions from internal and external stakeholders, reviewing
medical and scientific literature for safety information, and
supporting Clinical Trial activities.
Here's What You'll Do:
* Partner with the PV physicians to provide scientific/clinical
expertise, strategic input, and support for deliverables and
activities associated with signal management activities, management
of potential safety issues, evaluation of databases for safety
signals, and drafting of responses to regulatory inquiries/IRB/EC
requests on product safety issues for assigned product(s) during
all phases of the product life-cycle
* Effective communication skills for close collaboration with
colleagues from other functions including but not limited to
Clinical Development, Biostatistics, Regulatory Affairs, and
Medical Affairs
* Review safety sections and provide safety content for study
protocols, statistical analysis plans, eCRFs, ICF and other
clinical study-related documents as well as standard design of
tables, figures, and listings for safety data from clinical
studies
* Support updates to Investigator Brochure, Company Core Safety
Information, and other Reference Safety Information
* Review and prepare adverse event data, literature, and other
safety-relevant data for the purpose of signal analyses
* Contribute to safety contents for aggregate reports and risk
management plans
Here's What You'll Bring to the Table:
* Degree in Pharmacy, Nursing, Epidemiology, Biosciences or
equivalent healthcare degree with pharmaceutical industry
background
* Minimum 6 years pharmacovigilance experience including safety
signal management, clinical trial support and aggregate report
* Expertise in Argus Safety Database, MedDRA, Sharepoint, Microsoft
Office, and Excel.
* Skilled at working effectively in a collaborative team
environment where results are achieved through influence and the
incorporation of multiple points of view
* Excellent time management skills
* Independently motivated, detail oriented and strong
problem-solving ability
* Excellent organizational skills and demonstrated ability to
multi-task in a fast-paced environment with changing priorities
* Excellent written and verbal communication skills with the
ability to interact across multiple functions
* Knowledge in global pharmacovigilance regulations
Moderna is pleased to provide you and your family with a
comprehensive and innovative suite of benefits, including:
* Highly competitive and inclusive medical, dental and vision
coverage options
* Flexible Spending Accounts for medical expenses and dependent
care expenses
* Lifestyle Spending Account funds to help you engage in personal
enrichment and self-care activities
* Family care benefits, including subsidized back-up care options
and on-demand tutoring
* Free premium access to fitness, nutrition, and mindfulness
classes
* Exclusive preferred pricing on Peloton fitness equipment
* Adoption and family-planning benefits
* Dedicated care coordination support for our LGBTQ+ community
* Generous paid time off, including:
* Vacation, sick time and holidays
* Volunteer time to participate within your community
* Discretionary winter shut down
* Paid sabbatical after 5 years; every 3 years thereafter
* Generous Paid Leave offerings, including 18 weeks of 100% paid
parental leave for all new parents
* 401k match and Financial Planning tools
* Moderna-paid Life, LTD and STD insurance coverages, as well as
voluntary benefit options
* Complimentary concierge service including home services research,
travel booking, and entertainment requests
* Free parking or subsidized commuter passes
* Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a
policy requiring all US-based employees to be fully vaccinated
against COVID-19 and receive a booster shot once eligible. Newly
hired employees must be vaccinated and boosted prior to their
employment start date. Moderna is an equal opportunity employer and
will provide a reasonable accommodation to those unable to be
vaccinated or receive a booster where it is not an undue hardship
to the company to do so as provided under federal, state, and local
law.
About Moderna
In over 10 years since its inception, Moderna has transformed from
a research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across seven modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for rapid clinical and commercial production at
scale. Moderna maintains alliances with a broad range of domestic
and overseas government and commercial collaborators, which has
allowed for the pursuit of both groundbreaking science and rapid
scaling of manufacturing. Most recently, Moderna's capabilities
have come together to allow the authorized use and approval of one
of the earliest and most effective vaccines against the COVID-19
pandemic.
Moderna's mRNA platform builds on continuous advances in basic and
applied mRNA science, delivery technology and manufacturing, and
has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and autoimmune diseases. Moderna has been named a top
biopharmaceutical employer by Science for the past seven years. To
learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work
environment.
Moderna is committed to equal employment opportunity and
non-discrimination for all employees and qualified applicants
without regard to a person's race, color, gender, age, religion,
national origin, ancestry, disability, veteran status, genetic
information, sexual orientation or any characteristic protected
under applicable law. Moderna will make reasonable accommodations
for qualified individuals with known disabilities, in accordance
with applicable law.
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Keywords: Moderna Theraputics, Cambridge , Associate Director, Pharmacovigilance Scientist, Executive , Cambridge, Massachusetts
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