Associate Director, Drug Safety & Pharmacovigilance Operations
Company: Sage Therapeutics
Location: Cambridge
Posted on: January 27, 2023
Job Description:
General Scope and SummarySAGE Therapeutics is searching for a
creative, resourceful, integrative thinker for an important role as
the Associate Director, Drug Safety & Pharmacovigilance Operations.
The Associate Director, DSPV Operations will work on projects and
processes that ensure the strategies of the department are executed
within global safety legislation and requirements. The successful
candidate will have a proactive and innovative approach and a
flexible, hands-on nature that works with a high sense of urgency.
Effective communication skills will be key as this role provides an
excellent opportunity for close collaboration with colleagues from
other functions such as Clinical Operations & Development, Medical
Science, Data Science, Regulatory Affairs & Operations, Quality
Systems, and Medical Affairs.Roles and ResponsibilitiesThe
responsibilities of this position are not limited to just the
activities listed below, but may expand as the needs of the DSPV
Operations team evolve:Management:
- May have direct line management responsibilities for DSPV
Operations personnel, as business needs require.
- Collaborate with direct reports in establishing annual goals
that are aligned with Sage Corporate goals and ensure that goals
are related to professional growth and development.
- Actively provide ongoing evaluation of direct reports goals
throughout the year utilizing the Sage Checkpoint process.
- Assist with the development and maintenance of the onboarding
curriculum for new DSPV Operations staff.
- Represent DSPV Operations as a leader on project teams and
committees, as required.
- Contribute to projects that involve the implementation of new
processes and methods within and across DSPV Operations.Vendor
Oversight:
- Contribute to the selection of DSPV vendors to support an
outsourced business model.
- Participate in the review and approval of new DSPV vendor work
orders and change orders, as needed.
- Review and execute DSPV Operations safety data collection and
management strategy across clinical trial and commercial
programs.
- Provide vendor oversight and management of outsourced DSPV
activities, including but not limited to monitoring key quality and
compliance metrics and reviewing key documents/deliverables,
including but not limited to the Safety Management Plan (SMP),
Communications Plan, Quality Management Plan (QMP), etc.
- Oversee the timely submission of safety reports to global
health authorities, license partners, investigator sites, and
IRBs/ECs.
- Identify and review deviations and corrective and preventive
actions to maintain compliance with all applicable global
regulations.Clinical Study DSPV Operations Oversight:
- Represent DSPV Operations on Study Management Teams (SMTs) for
assigned studies and/or compounds.
- Oversee the set-up of new studies and compounds, including but
not limited to the development of SMPs, safety reporting forms, and
safety database configurations to accommodate these new studies and
compounds.
- Contribute to the update and review of study-specific protocols
and project plans, as applicable.
- Participate in the creation and dissemination of appropriate
safety reporting language in commercial and clinical trial key
documents.
- Actively participate in cross-functional teams that develop and
support strong cross-functional relationships and
communication.
- Represent DSPV Operations on cross-functional project teams to
ensure compliance with safety data collection and management
standards and operational consistency across clinical trials and
commercial programs.Inspection Readiness:
- Represent DSPV Operations on cross-functional inspection
readiness teams for both clinical trial and commercial
programs.
- Actively participate in internal audits and global regulatory
inspections as an SME for specific DSPV topics and processes, as
needed.
- Assist with the response(s) to DSPV Operations findings and
implementing corrective actions from internal audits and/or global
regulatory inspections.
- Contribute to the identification of deviations and the
determination of the corrective and preventive actions necessary to
maintain compliance at its highest level.
- Participate in the development and maintenance of DSPV
Operations procedures related to the processing and reporting of
SAEs from clinical trials and marketed products to ensure compliant
case processing.Experience, Education and Specialized Knowledge and
SkillsMust thrive working in a fast-paced, innovative environment
while remaining flexible, proactive, resourceful, and efficient.
Must have excellent interpersonal skills, the ability to develop
important relationships with key stakeholders, good conflict
management and negotiation skills, and the ability to identify
issues and raise to key stakeholders in order to develop relevant
and realistic plans, programs, and recommendations. Must have a
demonstrated ability to translate strategy into action, excellent
analytical skills, and an ability to communicate complex issues in
a simple way and to orchestrate plans to resolve issues and
mitigate risks.Basic Qualifications
- Bachelors degree in life sciences, pharmacy, nursing, or
equivalent health experience; advanced life sciences degree.
- 5-7+ years of experience in a Drug Safety/Pharmacovigilance
role in the pharmaceutical/biotechnology industry, including global
clinical trials and post-marketing.
- Experience using Argus or other Safety Database application
such as ARISg is required.Preferred Qualifications
- Masters degree in healthcare related profession preferred, but
not essential.
- Knowledge of FDA, ICH, and EU Regulations and Requirements for
Pharmacovigilance.
- Strong analytical and problem-solving skills with excellent
attention to detail.
- Strong verbal, written, and technical communication and
presentation skills.
- Proficiency in standard desktop software programs (Word, Excel,
Outlook).
- Possesses strong written and verbal communication skills.
- Strong team player that is solution-oriented.
- Attention to detail and the ability to work individually,
within a multi-disciplinary team, as well as with external partners
and vendors.
- Vendor management experience.
- Previous managerial role in drug safety preferred, but not
essential.
- Experience using an ad hoc querying tool, such as PV Query,
preferred but not essential.
- Embrace our Core Values: Put People First, Improve Lives,
Cultivate Curiosity, Do Right, and Forge New Pathways.
- Excitement about the vision and mission of Sage.Benefits and
CompensationThe base salary hiring range for this position is
$146,312 - $201,179.*
- The actual salary offered within the range is dependent on a
variety of factors including, but not limited to, relevant
experience, qualifications, education, skills, and
performance.
- This position is eligible to participate in the Companys annual
bonus plan; the bonus varies based on performance and is subject to
the standard terms and conditions of the incentive program.
- To support your well-being, we offer a comprehensive benefits
and wellness package, which includes medical, dental, and vision
coverage upon hire. More information can be found in our Benefits
Guide
(https://careers.sagerx.com/media/ngth5cdv/sage-us-benefits-guide.pdf)
.*Base salary ranges are periodically reviewed and subject to
change. #LI-RemoteProtected personal characteristics include: age,
race, ancestry, color, sex, national origin, sexual orientation,
gender identity or expression, religious creed, mental or physical
disability, pregnancy, genetic information, marital or civil union
status, participation in the uniformed services of the United
States, or any other characteristic protected under applicable
federal, state or local law. To learn more, see Sage's
Anti-Harassment and Equal Opportunity Policy
Keywords: Sage Therapeutics, Cambridge , Associate Director, Drug Safety & Pharmacovigilance Operations, Executive , Cambridge, Massachusetts
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