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Senior Manager, Pharmacovigilance Quality
4 months ago
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job DescriptionThe Senior Manager, Pharmacovigilance (PV) Quality encompasses a key leadership role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where applicable).
This position will report to the Director, Pharmacovigilance Operations and be in the Waltham office.
Key Responsibilities:
- Conducts gap analyses and prepares PV subject matter experts in preparation for regional PV audits and inspections of the PV system
- Conducts investigations into quality issues identified within PV and ensures event analyses, root cause investigations, corrective, and preventive actions (CAPA) are thoroughly documented
- Ensures PV support is provided to QA teams to facilitate the preparation and management of regional regulatory inspections (i.e. US, EU and other applicable countries); provides inspection readiness training and ongoing communication of the outcomes of such inspections to internal PV team
- Develops PV storyboards for utilization during PV audits and inspections
- Ensures the effective functioning of PV quality management system in compliance with global regulatory authority expectations
- Supports the development and implementation of PV Key Performance Indicators (KPI's) used to determine the effectiveness of the overall pharmacovigilance system
- Provides PV support to the conduct of audits and inspections of business partners and vendors conducting PV activities on behalf of Deciphera
- Conducts follow-up of business partner and vendor CAPA plans implemented because of findings identified during PV audits and inspections
- Supports the implementation of business continuity plans globally
- Represents PV as a subject matter expert during audits and inspections
- Responsible for the definition of standards and the timely management of PV policies, Standard Operating Procedures (SOP) and Working Instructions (WI)
- Reviews and coordinates subject matter input into cross-functional policies, SOPs & WIs
- Manages the authoring/review/approval and ongoing maintenance of the PV Quality Management Plan with vendors, as applicable
- Executes the monitoring and impact assessment of any business process changes on existing controlled documents, including the Pharmacovigilance System Master File (PSMF)
- Ensures the PSMF is maintained alongside, PSMF Sub-system files (PSSF) and summaries in accordance with Global, EEA and ex-EEA regulatory authority requirements
- Manages the PSMF schedule and works with key PSMF contributors to ensure timely and accurate update and submission of the PSMF upon request
- Creates/updates PV Agreement with PV partners and tracks compliance of PV team to the Agreements
- Responsible for training matrices, schedules and curricula developed, implemented, and maintained across PV
- Identifies and resolves non-compliance of PV, Vendors and Business partner staff for mandatory PV related training items on an ongoing basis
- Collaborates with Deciphera QA to support the development and implementation of effective PV training compliance of stakeholders outside of PV
- Contributes to the definition of measures used to assess the effectiveness of training programs
- Develops, implements, and maintains a repository of PV staff member CVs, training records and job descriptions in collaboration with Deciphera QA policies, practices, and procedures
- Ensures the continuous availability of all PV related documents, including but not limited to standards and procedures, governance meeting minutes, safety topic reviews/assessment reports and training content
- Ensures integrity of PV internal repositories and conformance with Deciphera records retention policies
- Ensures safety operations Distribution Lists (DL), mailboxes and other inbound communication channels are triaged and managed on an ongoing and timely basis as applicable
- Supports the functioning of the office of the EU QPPV
- Manages communication of regional QMS activities to functional areas and senior management
- Supports data provisioning for benchmarking activities
- Contributes to strategic initiatives across PV, as required
Required Qualifications:
- Education: BS degree in nursing, pharmacy, or other health care or life sciences related profession with 12+ years of experience in Pharmacovigilance operational and Quality roles in a pharmaceutical or healthcare industry setting
- Minimum two (2) years of experience with people leadership or team leadership experience
- Minimum Five (5) years of experience leading regulatory inspection and audit readiness activities including management of the resolution of audit and inspection outcomes
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Experience with selection and working with contract service providers for case processing, aggregate reporting, and quality management activities
- Experience with regulatory inspections and company audits including MHRA/EMA PV inspections
- Experience in the management of pharmacovigilance quality management systems; implementing cross-functional partnerships and business processes; managing the development of standard operating procedures and working instructions
- Strong command of Global pharmacovigilance requirements (including EU GVP and US)
- Demonstrated experience managing compliance-based training programs for PV including the ongoing evaluation of training effectiveness
Preferred Qualifications:
- Ability to develop and influence relationships and partnerships (internal/external) across all levels of the organization, exhibiting strong leadership and influencing skills; can anticipate strategic business needs to ensure patient safety operations remain compliant
- Excellent oral and written communications, including experience in public speaking and group facilitation
- Excellent interpersonal skills, and a high level of personal integrity
Additional Information
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:
- Patients – We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
- Accountability – We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
- Transparency – We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
- Honesty and Integrity – Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
- Stewardship – We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
“How” we work together and the behaviors that we show up with each day are critical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:
- Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.
- Drive business results – we navigate forward with our eye on the highest priorities.
- Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
- Continuously evolve and improve – we try, we learn, we revise and try again.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- ESPP offering
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
- [if applicable] Car allowance
Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
