Senior Manager, Pharmacovigilance and Risk Management
3 weeks 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 Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. She/he must possess knowledge and skills to ensure that safety data analyses and reports are of high quality and in adherence to requirements and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate data is a key success factor for this role.
The position may be filled at the Associate Director or Senior Manager level and will report to the Pharmacovigilance Risk Management Lead in Waltham, MA.
What You’ll Do:
- Serve as the analytical safety lead for the assigned program(s)/product(s).
- Responsible for signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
- Review data outputs and literature, interpret and communicate findings.
- Analyze data for aggregate safety reports (e.g., DSURs, PADERs, PBRERs), and ad-hoc regulatory requests.
- Support Risk Management Plan (RMP) related activities.
- Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.
- Minimum 6 years of relevant medical, scientific/clinical, or pharmaceutical experience, including 2 years of experience in drug safety.
- Advanced degree (PharmD, MD, PhD, MPH, NP, MS).
- Demonstrated experience in analysis and interpretation of medical and scientific data.
- In-depth understanding of research methods and procedures; strong background in epidemiological theory, methods, or health informatics is a plus.
- Experience in signaling activities, aggregate reports authoring, and responding to regulatory requests.
- Strong knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.
- Familiarity with case processing, expedited reporting rules, and safety database concepts.
- Strong knowledge/proficiency with Microsoft Office Suite and Argus Safety systems; knowledge of software such as SAS, Stata, SPSS is a plus.
- Excellent verbal and written communication skills.
- Strong organizational, project management, and leadership skills.
- Attention to detail and ability to think critically required.
Additional Information
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.
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Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. She/he must possess knowledge and...
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