Director, Pharmacovigilance and Drug Safety (Safety Science)
Company: Xenon Pharmaceuticals Inc.
Location: Boston
Posted on: October 19, 2024
Job Description:
Director, Pharmacovigilance and Drug Safety (Safety Science)
Boston, MA, USA Req #259 Friday, July 12, 2024 Who We Are:
Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused
biopharmaceutical company committed to discovering, developing, and
commercializing innovative therapeutics to improve the lives of
people living with neurological and psychiatric disorders. We are
looking for great people who thrive in a respectful, collaborative,
inclusive, and productive culture to join the Xenon team. What We
Do:
We are advancing an exciting product pipeline to address
indications with high unmet medical need, including epilepsy and
depression. Our flagship azetukalner program represents the most
advanced potassium channel modulator in clinical development for
multiple indications. Building upon the positive results and
compelling data from our Phase 2b "X-TOLE" study in adult patients
with focal epilepsy, our Phase 3 epilepsy program includes multiple
clinical trials evaluating azetukalner in patients with focal onset
seizures and primary generalized tonic-clonic seizures. In 2024, we
are planning to initiate a Phase 3 azetukalner program in major
depressive disorder, based on topline data from our Phase 2
"X-NOVA" clinical trial. In addition, we are proud of the
leading-edge science coming out of our discovery labs, including
early-stage research programs that leverage our extensive ion
channel expertise and drug discovery capabilities to identify
validated drug targets and develop new product candidates. Backed
by a strong balance sheet to support our growth plans, we continue
to build a fully integrated, premier neuroscience company with
strong discovery, clinical development, corporate, and commercial
operations.
About the Role:
We are seeking a Director, Pharmacovigilance and Drug Safety
(Safety Science) to join our team. The incumbent is responsible for
safety surveillance and aggregate safety reports and works with
safety physicians for signal/risk management for assigned Xenon's
products to support product safety and compliance with global drug
safety regulations and departmental procedures and provide vendor
oversight to CROs. The Directo demonstrates effective
prioritization, critical thinking and judgment-based
decision-making to execute key deliverables in compliance with
global regulations and internal processes. The individual authors
safety documents, review safety sections of other documents for
Xenon products throughout the product lifecycle from First-in-Human
(FIH) to post-marketing, performs QC and maintains document control
of safety documents. This individual will organize cross-functional
Safety Management Team meetings and collaborate with colleagues in
Clinical Development, Trial Operations, Clinical Pharmacology,
Biostatistics & Programming, Regulatory, Medical Affairs,
non-clinical safety lead, QA and Legal departments. This individual
oversees the ICSR data quality from safety vendors and ensures
compliance with all applicable US and foreign legal and regulatory
requirements for signal detection, evaluation and risk management
of products. This position reports to the Senior Director,
Pharmacovigilance and Drug Safety (Safety Science) and will be in
Boston, MA, USA. We will consider other jurisdictions for
exceptional candidates. The level of the position will be
commensurate with the candidate's education and industry
experience. RESPONSIBILITIES:
- Author safety signal assessment reports and aggregate safety
reports, write and maintain relevant SOPs and procedures in
compliance with global safety regulations and guidelines, and
provide training within DSPV and cross-functionally
- Provide vendor oversight for the quality of ICSRs, similar case
analysis, and aggregate safety reporting; support initiatives from
the scientific and PV regulation perspective such as inspection
readiness, and launch readiness
- Organize and facilitate cross-functional Safety Management Team
(SMT) meetings for signal management, risk management detect, and
benefit-risk assessment for Xenon products, prepare the meeting
minutes, and track actions
- Compile safety information for aggregate safety reports in
support of periodic safety data review meetings.
- Review safety concerns escalated from internal and external
stakeholders, including competent regulatory authorities, and
provide support to develop strategies for safety assessment in
collaboration with the Head of DSPV, Lead safety scientist, and
safety physicians
- Review and communicate trending, signaling, and other
safety-related issues originating from any source for the purposes
of detecting and reviewing safety signals (e.g., change in
frequency, nature, or severity of a safety-related issue) in a
timely manner
- Review potential issues and safety signals and contribute to
the Safety Governance process through the preparation and
presentation of safety data; prepare and assess safety data for
ongoing periodic/aggregate safety data reviews, and provide
recommendations for review and approval by the Safety Advisory
Committee
- Lead across cross-functional teams including but not limited to
Non-clinical, Clinical Development, Trial Operations, Regulatory,
Biostatistics, and Clinical Data Management to generate
cross-functional safety documents such as DSUR and RMP
- Author safety-related documents for Xenon products throughout
the product lifecycle from FIH to post-marketing, including Similar
Case Analysis, Safety Assessment Reports for potential
signals/risks, RSI in IB, ADR in the CCDS and product labels,
Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PADER),
RMP/developmental RMP, and responses to ad-hoc requests for safety
information internally and externally
- Provide safety data and review IND Annual Reports in
collaboration with other stakeholders
- Review SMP, and provide input to safety-related sections of
clinical study documents including Study Protocols, Informed
Consent Forms (ICF), Clinical Study Reports (CSR), and other
relevant documents
- Perform medical review of Individual Case Safety Reports (ICSR)
including fields such as case narrative, MedDRA coding, labeling,
causality and company comment, and oversee the data quality of ICSR
from safety vendors
- Provide oversight of MedDRA and WHO Drug coding
- Schedule meetings for safety teams, clinical teams and vendors
for follow-up queries and company causality assessment for SAEs,
pregnancy and special cases in clinical trials.
- Perform QC (quality control) for multiple tasks and data
reconciliation of between the Clinical and the Safety Database
- Document Control: maintain electronic files for relevant DSPV
documents on the Xenon SharePoint or shared drives or other
system
- Assist department head to facilitate department meetings;
prepare agendas and meeting minutes; assist with vendor management
and oversight
- Act in accordance with Company policies, including, for
example, the Code of Business Conduct and Ethics and ensure
policies are understood and followed by direct reports, if any
- Other duties as assigned QUALIFICATIONS:
- Health Care Professional degree required (e.g., RN/BSN/MSN, NP,
PharmD) and 8+ years of pharmaceutical industry experience in drug
safety & pharmacovigilance as a Safety Scientist for products in
the clinical trial and post-marketing environments or MD with
4+years of clinical experience and 6+years of pharmaceutical
industry experience in Safety Science, Clinical Development, or
Clinical Research is preferred
- Experience authoring safety signal assessment reports, DSUR,
PBRER, RMP, and RSI
- Prior experience with Regulatory Agency interactions
- Skilled in signal detection process and managing safety
information from clinical development and post-marketing
sources
- Experienced with FDA/EMA regulations and ICH guidance governing
pharmacovigilance and risk management
- Knowledge of drug development process, pharmacovigilance
databases and MedDRA coding
- Experience with use of safety databases, preferably Argus
Safety Database
- Excellent verbal and written communication skills with the
ability to write clearly and concisely, and strong presentation
skills
- Time management skills with the ability to prioritize to meet
required deadlines
- Ability to multitask and prioritize under tight deadlines while
providing attention to detail and high-quality work in a dynamic
environment
- Ability to be flexible, adapt to change, work independently, as
well as experience working in a highly collaborative matrix
environment The base salary range for this role is $210,000 to
$239,500 USD; we will consider above this range for exceptional
candidates. Base salary is determined by a combination of factors
including, but not limited to, education and other qualifications,
years of relevant experience, and internal equity. Our Total
Rewards program includes base salary, target bonus, and stock
options, as well as a full range of benefits including medical,
dental, vision, short-& long-term disability, accidental death &
dismemberment, and life insurance programs, Employee Assistance
Program, travel insurance, and retirement savings programs with
company matching contributions.
Xenon encourages time to rest and re-charge through vacation,
personal days, sick days, and an end-of-year company shutdown.
Xenon highly values employee development and has an expanding
Training, Learning & Development program, including a Tuition
Assistance program for advanced degrees.
US positions only:Xenon Pharmaceuticals USA Inc. participates in
the E-Verify program in all states in which we hire. Learn more
about the E-Verify program here . To apply for this position, click
Apply Now to complete the application. We thank all applicants for
their interest; however, due to the volume of applicants, only
those chosen for interview will be contacted.
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Keywords: Xenon Pharmaceuticals Inc., Somerville , Director, Pharmacovigilance and Drug Safety (Safety Science), Executive , Boston, Massachusetts
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