Description
General Scope and Summary
SAGE 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 Responsibilities
The 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 Skills
Must 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
Bachelor's 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
Master's 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.
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Nondiscrimination
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.
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