(Contract) Manager, Pharmacovigilance Operations
Company: Moderna Theraputics
Posted on: June 10, 2021
Moderna is seeking a Pharmacovigilance Operations Manager to
provide key operational support throughout the lifecycle of
Moderna's products. The successful candidate will aid Moderna's PV
Operations leadership in the oversight of PV activities including,
but not limited to, vendor oversight and oversight of ICSR and
Here's What You'll Do:
Provide expertise on PV Operations processes to cross-functional
teams (i.e. Data Management, Clinical Development, Medical Affairs,
etc.), as required
Review and provide input for data entry conventions and
specifications for the global safety database.
Aid in the development and maintenance of training materials for
case processing teams.
Conduct and support PV Operations activities to ensure
compliance with regulatory requirements and maintain regulatory
inspection readiness in collaboration with Quality Assurance.
Monitor Clinical Trial SUSAR workflow, reviewing the quality of
reports and ensuring timely PV medical review.
Assist the Clinical Safety and Risk Management team with
maintenance of AE Data Collection forms for Safety follow-up and
List of Expected Events.
Exchange of safety data with partners, as required.
Collaborate with Data Management and Clinical Development teams
by reviewing and providing input into documentation and guidelines
for clinical trials that impact PV activities, including Case
Report Forms, CRF Completion Guidelines, SAE and Safety Events
Reconciliation plans, etc.
Contribute to development of safety-related SOPs and guidelines
and conduct training.
Contribute to the collection, organization, and presentation of
all required global PV compliance metrics including vendor and
partner oversight metrics.
- Assist with preparation and execution of inspection activities
during Regulatory Authority inspections and internal audits.
Here's What You'll Bring to the Table:
Bachelor's degree or higher in a life science required -
healthcare professional preferred
Minimum 5 years recent experience in pharmacovigilance/drug
safety, or relevant scientific/clinical, or pharmaceutical
Working knowledge of global pharmacovigilance regulations
Knowledge of MedDRA terminology and its application
In depth knowledge of safety database structure and use,
including ICH E2B reporting format
Demonstrated ability to develop, execute and follow-through
complex projects to completion
Skilled at working effectively in a collaborative team
environment where results are achieved through influence and the
incorporation of multiple points of view
Independently motivated, detail oriented and strong
Excellent organizational skills and demonstrated ability to
multi-task in a fast-paced environment with changing priorities
- Outstanding written and verbal communication skills with the
ability to build successful relationships with cross-functional
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the
promising-but-still-unproven field of messenger RNA (mRNA), to an
enterprise with its first medicine having treated millions of
people, a diverse clinical portfolio of vaccines and therapeutics
across six modalities, a broad intellectual property portfolio in
areas including mRNA and lipid nanoparticle formulation, and an
integrated manufacturing plant that allows for both clinical and
commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work
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.
Keywords: Moderna Theraputics, Cambridge , (Contract) Manager, Pharmacovigilance Operations, Other , Cambridge, Massachusetts
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