Senior Director Drug Safety and Pharmacovigilance
Company: ACADIA Pharmaceuticals Inc.
Location: San Diego
Posted on: May 18, 2024
Job Description:
Senior Director Drug Safety and PharmacovigilancePlease note
that this position is based in San Diego, CA. Acadia's hybrid model
requires this role to work in our office three days per week on
average.Responsible for supporting the overall strategy and
approaches within Medical Safety and supporting the PV management
on scientific topics, and interacting with Acadia
executives/leaders with respect to issues related to benefit/risk.
Responsible for content and quality of Acadia risk
communications.Primary Responsibilities
- Develop strategies, working with the Head of Safety, to achieve
PV Medical Safety goals.
- Along with the Head of Safety, represent PV in communications
with health authorities such as the FDA.
- Assess safety signals and trends and proactively manage any
potential safety issues.
- Formulate response strategies and author responses for health
authority requests.
- Determine the need for pharmacoepidemiology, including input
and liaise with external pharmacoepidemiologists.
- Ensure PV Medical Safety activities are performed in compliance
with all applicable regulations and Acadia standards.
- Assist with oversight of the vendor performing medical review
of ICSRs and aggregate report on behalf of Acadia.
- Perform medical review of serious adverse events from Acadia
clinical trials.
- Accountable for medical evaluation/interpretation of aggregate
safety data of assigned product(s) including signal detection and
evaluation, and ad hoc safety assessments.
- Provide oversight for the safety aspects of clinical studies,
and development and maintenance of the company core safety
information.
- Provide support for safety sections of clinical documents,
including the review and approval of the safety portion of
protocols, annual reports (DSUR), final study reports, IB and other
documents as needed.
- Lead development of Risk Management Plans, implementation and
evaluation of their effectiveness.
- Ensure safety issues are communicated to the appropriate
stakeholders in a timely fashion.
- Author analysis of similar events (AOSE) and individual case
comments for ICSRs.
- Maintain knowledge of global regulatory authority regulations
including FDA and EMA.
- Contribute to the training, leadership and continuing education
of department staff.
- Other duties as assigned.Education and ExperienceMD degree or
equivalent with clinical post-training resulting in eligibility for
a US medical board certification. Targeting 12 years of relevant
drug safety experience in the biotechnology/pharmaceutical
industry, including safety leadership experience. MPH or
pharmacoepidemiology expertise desired. Neurology, psychiatry, or
CNS-related disease experience preferred.Key Skills:
- Highly-developed scientific and analytical knowledge base and
an excellent understanding of good pharmacovigilance practices and
current regulations within drug safety.
- Proficiency at creating and communicating a clear vision and
activities to achieve functional area and/or organizational
goals.
- Strength in analysis, critical decision-making and bottom line
accountability.
- Working knowledge of validated drug safety databases
(preferably ARGUS) and MedDRA.
- Thorough understanding of U.S. pharmacovigilance regulations,
GCP and International Conference on Harmonization (ICH)
guidelines.
- Extensive experience in authoring of all types of aggregate
safety reports including setting a strategy to address potential
safety issues.
- In-depth understanding of the drug development process.
- Extensive experience in partnering with vendorsto achieve
results.
- Exceptional written and verbal communication skills.
- Skilled at negotiating with business partners or managing and
influencing senior level leaders regarding matters of significance
to the organization.
- Ability to think strategically at the executive level,
implement change, incorporate innovation, and implement strategies
throughout all levels of the organization.
- Ability to build and sustain trusted relationships both
internally and externally.
- Proficient computer skills, including Argus, Microsoft Word,
PowerPoint and Excel.Physical RequirementsWhile performing the
duties of this job, the employee is regularly required to stand;
walk; sit; use hands to finger, handle, or feel; reach with hands
and arms; climb or balance; stoop, kneel, crouch, see, talk or hear
in a standard office environment and independently from remote
locations. Employee must occasionally lift and/or move up to 20
pounds. Ability to travel independently overnight and work after
hours if required by travel schedule or business needs. #LI-MS1
#LI-HYBRID In addition to a competitive base salary, this position
is also eligible for discretionary bonus and equity awards based on
factors such as individual and organizational performance. Actual
amounts will vary depending on experience, performance, and
location. Salary Range $239,000 - $299,100 USD What we offer you
(US-Based Employees):
- Competitive base, bonus, new hire and ongoing equity
packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price
lock-in
- 14 paid holidays plus one floating holiday of your choice,
including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistanceEEO Statement (US-Based Employees):Studies
have shown that women and people of color are less likely to apply
for jobs unless they believe they meet every single one of the
qualifications in the exact way they are described in job postings.
We are committed to building a diverse, equitable, inclusive, and
innovative company and we are looking for the BEST candidate for
the job. That candidate may be one who comes from a less
traditional background or may meet the qualifications in a
different way. We would strongly encourage you to apply -
especially if the reason you are the best candidate isn't exactly
as we describe it here.It is the policy of Acadia to provide equal
employment opportunities to all employees and employment applicants
without regard to considerations of race, including related to
hairstyle, color, religion or religious creed, sexual orientation,
gender, gender identity, gender expression, gender transition,
country of origin, ancestry, citizenship, age, physical or mental
disability, genetic information, legally-protected medical
condition or information, marital status, domestic partner status,
family care status, military caregiver status, veteran or military
status (including reserve status, National Guard status, and
military service or obligation), status as a victim of domestic
violence, sexual assault or stalking, enrollment in a public
assistance program, or any basis protected under federal, state or
local law.As an equal opportunity employer, Acadia is committed to
a diverse workforce. If you are a qualified individual with a
disability or a disabled veteran, you have the right to request a
reasonable accommodation. Furthermore, you may request additional
support if you are unable or limited in your ability to use or
access Acadia's career website due to your disability, along with
any accommodations throughout the interview process. To request or
inquire about your reasonable accommodation, please complete
ourReasonable Accommodation Request Form or contact us
attalentacquisition@acadia-pharm.com or 858-261-2923 .Please note
that reasonable accommodations granted throughout the recruiting
process are not guaranteed to be the same accommodation given if
hired. A new request will need to be submitted for any ADA
accommodations after starting employment.Notice to Search
Firms/Third-Party Recruitment Agencies (Recruiters): The Talent
Acquisition team manages the recruitment and employment process for
Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept
resumes from recruiters or search firms without an executed search
agreement in place. Resumes sent to Acadia employees in absence of
an executed search agreement will not obligate Acadia in any way
with the respect to the future employment of those individuals or
potential remuneration to any recruiter or search firm. Candidates
should never be submitted directly to our hiring managers or
employees.
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Keywords: ACADIA Pharmaceuticals Inc., National City , Senior Director Drug Safety and Pharmacovigilance, Executive , San Diego, California
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