Associate Director, Pharmacovigilance Scientist
Deciphera Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Waltham • Massachusetts • United States
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Salary
💰 $162,000 - $223,000 per year
Job Level
About the role
- 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-related regulatory queries, including data coordination and analysis.
- Contributes 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 inspection.
- 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 the team.
- Supports deliverables for other products, where needed.
- Manages, mentors, and trains junior members of the team.
- Supports individual development of direct reports.
Requirements
- 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 track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs.
- Prior experience serving as an SME in audits and/or inspections.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesignal detectiondata analysisaggregate safety reportsrisk management plansliterature surveillanceregulatory filingsimpact assessmentsprocess improvementfunctional training
Soft Skills
communication skillsdetail-orientedcritical thinkingprioritizationindependencementoringteam leadershipknowledge sharingstrategic innovationinspection readiness
Certifications
PharmDRNMDPhDMPHNPMS