Senior Medical Director, Pharmacovigilance

Deciphera Pharmaceuticals • Waltham, MA

5d • $292,000 - $402,600 • Hybrid

About The Position

We are seeking a Senior Medical Director, Pharmacovigilance to support global pharmacovigilance for marketed and/or investigational products. In this role, you will be responsible for overseeing activities such as medical review of cases, signal management, aggregate reports, risk management, ad hoc safety query responses, literature surveillance, safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (protocols, IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable) while serving as a key medical expert in cross-functional teams and regulatory interactions.

Requirements

• MD from an accredited institution (board certified preferred; board eligible or OUS equivalent)
• 10 + years of pharmacovigilance / drug safety experience, leadership role within a pharmaceutical, biotechnology, or CRO environment
• Strong scientific/clinical and analytical background; able to assess data and interpret safety/medical implications
• Proficient in understanding and evaluating technical, scientific, and medical information; experienced with clinical data collection, assessment, and analysis
• Proven ability to work independently or collaboratively within teams (Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory) and with external partners
• Solid understanding of global drug development and pharmacovigilance guidelines/regulations
• Highly detail-oriented, organized, and capable of managing multiple tasks to meet deadlines
• Strong teamwork, collaboration, and effective verbal and written communication skills

Nice To Haves

• Demonstrated expertise in a broad range of therapeutic areas, showcasing adaptability and depth of medical knowledge.
• Proven ability to excel in dynamic, high-growth international settings, effectively navigating cross-cultural and multidisciplinary teams.
• Advanced skills in utilizing industry-standard pharmacovigilance systems (such as Argus and ARISg), the Microsoft Office, and medical coding dictionaries, with the added capability to implement emerging digital tools, optimize workflow automation, and analyze large datasets for actionable safety insights.
• Strong project management skills
• Ability to lead global process optimization initiatives
• Experience in designing and delivering training programs to enhance team performance in pharmacovigilance operations.

Responsibilities

• Lead benefit risk for the assigned products (50%)
• Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned products throughout the life cycle of the compound.
• Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
• Oversee team contributions to safety-critical documentation such as regulatory submissions (INDs, NDAs, MAAs)
• Attend/lead Safety Committee meeting to support key decision-making, drive conclusions and develop next steps
• Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
• Participate in development and maintenance of risk management plans (RMPs) and REMS as applicable.
• Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
• Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports as needed
• Contribute to preparation of relevant regulatory documents and responses to regulatory agencies, Institutional Review Board (IRB), Investigational Site and Medical Information queries
• Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
• Lead the medical review activities for ICSRs (30%)
• Perform medical review and assessment of adverse event reports for marketed and investigational products, including review of coding, consistency in assessment, case narrative, company assessment and case documentation
• Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
• Adhering to documented procedures and company/vendor timelines for ICSRs submission
• Attend Kick-Off meetings, weekly case medical review, study team meetings, and vendor meetings, and other meetings as needed or requested.
• Lead the safety related sections of the study documents (15%)
• Ensure appropriate safety content of the study documents such as study protocol (s), Investigator Sponsored Research (ISR), Investigator Brochure /Reference Safety Information, Informed Consent Form risk language
• Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion criteria, and issues of patient safety and/or eligibility, IRB responses for safety related queries
• Present and lead safety data presentation in Data Monitoring Committee (DMC) and participate in data review meetings
• Other duties and responsibilities as assigned (5%)

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