- Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
- Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
- Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
- Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
- Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility
- Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)
- Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment
- Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative
- Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested
- Support inspections and audits, act as a subject matter expert for the assigned program (s)
- Provide training on product and medical review to vendor/ team members as needed
- Completes tasks on time or notifies appropriate person with an alternate plan.
- Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
- Attend/lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps
- Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
- Participate in development and maintenance of risk management plans and REMS as applicable.
- Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
- Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
- Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries
- Provide consultation for medically related questions from participating vendors, affiliates, etc.
- Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues as appropriate
- Develop/assist in creation of internal SOP and review vendor SOPs as needed.
- Support in Inspections and Audits as needed
- Other relevant duties as assigned
- MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent)
- Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting
- Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
- Excellent oral and written communication skills including ability to present to large internal/external groups
- Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
- Work productively in a high-pressure environment
- Strong ability to understand and evaluate technical, scientific and medical information; exposure to clinical data collection, assessment, and analysis
- Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented
- Working knowledge of global drug development and pharmacovigilance guidelines and regulations
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Excellent teamwork and collaboration
- 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
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Medical Director, Pharmacovigilance - Watertown, United States - Deciphera Pharmaceuticals
Description
Company DescriptionDeciphera 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 Description
We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.
The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.
The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.
What You'll Do:
We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. 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.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
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.
