Associate Director, Pharmacovigilance Scientist

Job DescriptionThe Associate Director, Pharmacovigilance Scientist plays a critical role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. This individual also serves as a subject matter expert for the PV Sciences group, contributing to strategic initiatives in collaboration with key stakeholders.The Associate Director, Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will be responsible for leading and/or contributing to activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational products, this role may also encompass contributions to IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable. The Associate Director, Pharmacovigilance Scientist will also contribute to process improvement initiatives, lead strategic innovations, and manage/mentor others, as opportunities permit.Key ResponsibilitiesServes as lead PV Scientist for assigned product(s) – 60%Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentationLeads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs)Leads and manages the planning, preparation, writing, and review of risk management plansPerforms literature surveillancePrepares materials for safety governance meetingsContributes to safety-related regulatory queries, including data coordination and analysisContributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable)Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications)Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspectionOther functional and cross-functional initiatives – 25%Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.)Conducts impact assessments (e.g., updates to regulations, etc.)Leads process improvement initiatives and consistency of cross-product processesConducts functional trainings and shares knowledge with the teamSupports deliverables for other products, where neededManagement and mentorship – 15%Manages, mentors, and trains junior members of the teamSupports individual development of direct reportsOther duties and responsibilities as assignedQualificationsRequired Qualifications:Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar roleAdvanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)Demonstrated experience in analysis and interpretation of medical and scientific data, including experience leading signal management activities and the preparation and authoring of aggregate reports in both post-marketing and clinical trialsExcellent oral and written communication skills, including the ability to effectively communicate key considerations and decision pointsDetail-oriented with ability to think critically, prioritize tasks, and function independentlyExpert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulationsProven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPsPrior experience serving as an SME in audits and/or inspectionsPreferred Capabilities:Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.)Expert proficiency with pharmacovigilance databases and relevant coding dictionariesExpert knowledge/proficiency with Microsoft Office Suite and Argus Safety systemsAdditional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $162,000 - $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)Benefits:Competitive salary and annual bonus.Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.Generous parental leave and family planning benefits.Outstanding culture and opportunities for personal and professional growth.Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals