Senior Director, Pharmacovigilance Sciences Lead

Deciphera Pharmaceuticals • Waltham, MA

92d • $247,000 - $340,000

About The Position

The Senior Director, Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio. The Senior Director, Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct 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.), and contributions to key documents (IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable). The Senior Director, Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives, strategic innovations, and team leadership.

Requirements

• PhD or equivalent plus 10+ years of experience or Bachelors or Masters plus 15+ years of experience in a PV scientist role
• Demonstrated experience in analysis and interpretation of medical and scientific data, including experience in both post-marketing and clinical trials
• Excellent oral and written communication skills, including the ability to effectively communicate with senior leadership
• 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 the oncology therapeutic area
• Expert proficiency with pharmacovigilance databases and relevant coding dictionaries
• Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems

Responsibilities

• Oversees PV Sciences deliverables across the portfolio
• Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations, including signal detection, evaluation, and management
• Prepares aggregate safety reports (DSURs, PADERs, PBRERs)
• Develops risk management plans (including maintenance and implementation of risk minimization measures)
• Conducts literature surveillance
• Prepares safety governance meeting documentation
• Responds to safety-related regulatory queries
• Contributes to key documents (IB/RSIs, CCDS/labels, ICF, etc.)
• Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorisation Applications)
• Prepares for and executes inspections
• Sets strategy for the PV Sciences team, aligning with corporate goals and safety objectives
• Leads recruitment, mentoring, career development, and performance management of PV Sciences team
• Collaborates with cross-functional teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions
• Leads process improvements and conducts impact assessments
• Ensures appropriate training and individual development for direct and indirect reports
• Performs 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: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree