Associate Director, Pharmacovigilance Scientist

Deciphera Pharmaceuticals • Waltham, MA

2d • Hybrid

About The Position

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, 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.

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

Nice To Haves

• Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.)
• Expert proficiency with pharmacovigilance databases and relevant coding dictionaries
• Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems

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-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
• 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 the team
• Supports deliverables for other products, where needed
• Management and mentorship – 15%
• Manages, mentors, and trains junior members of the team
• Supports individual development of direct reports
• Other duties and responsibilities as assigned

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees