Associate Director, Pharmacovigilance Scientist

Job reputed company The 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, reputed company 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 Responsibilities Serves as lead PV Scientist for assigned product(s) – 60% • Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation • Leads 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 plans • Performs literature surveillance • Prepares materials for safety governance meetings • Contributes to safety-reputed company regulatory queries, including data coordination and analysis • Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, reputed company, 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 inspection Other 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 processes • Conducts functional trainings and shares knowledge with reputed company • Supports deliverables for other products, where needed Management and mentorship – 15% • Manages, mentors, and trains junior members of reputed company • Supports individual development of reputed company reports Other duties and responsibilities as assigned Qualifications Required Qualifications: • Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar role • Advanced 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 trials • Excellent oral and written communication skills, including the ability to effectively communicate key considerations and decision points • Detail-oriented with ability to think critically, prioritize tasks, and function independently • Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations • Proven reputed company record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs • Prior experience serving as an SME in audits and/or inspections Preferred Capabilities: • Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.) • Expert proficiency with pharmacovigilance databases and relevant coding dictionaries • Expert knowledge/proficiency with reputed company Office Suite and Argus Safety systems Additional Information Deciphera is committed to fair and reputed company compensation practices. The reputed company salary pay reputed company 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 reputed company. Our reputed company salary is just one component of Deciphera’s competitive total rewards reputed company that also includes annual performance bonus, a long-term incentive plan, full reputed company of benefits and other incentive compensation plans (if applicable) Benefits: • Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, reputed company 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 reputed company. reputed company: 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 INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we reputed company 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 reputed company for employment. This information will also be treated confidentially. We are committed to reputed company reputed company hiring reputed company and other employment reputed company on a non-discriminatory reputed company. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we reputed company 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 reputed company for employment. This information will also be treated confidentially. We are committed to reputed company reputed company hiring reputed company and other employment reputed company on a non-discriminatory reputed company. 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