Senior Medical Director, Pharmacovigilance

Deciphera Pharmaceuticals; Waltham (MA); On-site; USD 292,000 - 403,000; Full time

Benefits offered by this job

Competitive salary & bonus

Comprehensive benefits

Parental leave

Growth opportunities

Job summary

Deciphera Pharmaceuticals is seeking a Senior Medical Director, Pharmacovigilance to lead global pharmacovigilance for marketed and investigational products. The role oversees medical review of cases, signal management, aggregate reports, and regulatory submissions, while guiding cross-functional teams as a medical expert.

The position emphasizes leadership in benefit-risk management, medical review for ICIRs, safety content in study documents, and collaboration with Regulatory Affairs to ensure

Qualifications

• MD from an accredited institution; board certified preferred; board eligible or OUS equivalent.
• 10+ years pharmacovigilance/drug safety experience in pharma/biotech/CRO environments.
• Strong scientific/clinical and analytical background with ability to assess data.
• Proven experience with regulatory submissions (INDs, NDAs, MAAs) and safety reporting.
• Ability to lead cross-functional teams and communicate with regulatory bodies.

Responsibilities

• Lead and oversee safety surveillance, benefit-risk assessment and risk management for assigned products across their life cycle.
• Provide pharmacovigilance expertise for decision making based on risk/benefit, data analysis and interpretation.
• Oversee safety documentation for regulatory submissions (INDs, NDAs, MAAs).
• Attend/lead Safety Committee meetings to drive decisions and next steps.
• Collaborate with Regulatory Affairs and cross-functional teams on safety issues and risk assessments.
• Develop and maintain risk management plans (RMPs) and REMS as applicable.
• Serve as a key member on Product Safety Committee; present safety issues and risk mitigation strategies.
• Review PSUR/DSUR/PADER and other periodic safety reports.

Skills

Pharmacovigilance

Medical review

Risk management

Regulatory submissions

Team leadership

Cross-functional collaboration

Medical writing

Education

MD

Tools

Argus

ARISg

MS Office

Medical coding dictionaries

Job description

Senior Medical Director, Pharmacovigilance

• Full-time
• Job Location: Hybrid

We are seeking a SeniorMedical 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.

Key Responsibilities:

Leadbenefit 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 assignedproductsthroughout the life cycle of the compound.

Provides pharmacovigilance expertise to oversee and lead decision making based onrisk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation

Oversee team contributions to safety-critical documentationsuch asregulatory 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 reportsas 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 IC Rs (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 IC Rs submission

Attend Kick-Off meetings, weeklycase medical review, studyteam 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%)

Required Qualifications

MD from an accredited institution (board certified preferred; board eligible or OUS equivalent)

10+yearsof 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

Preferred Capabilities

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 andARISg), 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.

Additional capabilities include strong project management skills, the ability to lead global process optimization initiatives, and experience in designing and delivering training programs to enhance team performance in pharmacovigilance operations.

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $292,000 - $402,600. 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 all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

• 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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply 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 your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply 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 your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.