Medical Director, Pharmacovigilance

This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.

About the role

The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds and products. This role ensures upper management is informed of safety issues and may represent Deciphera, Drug Safety, and Risk Management at internal and external meetings. The successful candidate will demonstrate flexibility and capability to function at a high level in an entrepreneurial environment, interacting with multiple levels of management.

Responsibilities

• Leads and provides input and oversight of ongoing safety surveillance, benefit-risk assessment, and risk management activities for assigned products.
• Provides pharmacovigilance expertise to oversee and lead decision-making based on risk/benefit evaluation, data analysis, interpretation, risk assessment, and mitigation.
• Performs medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines.
• Ensures appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment.
• Provides medical support to cross-functional teams for protocol-related issues, including safety topics, inclusion/exclusion determinations, and patient safety/eligibility.
• Assists with the development of protocols, Investigative Drug Brochures (IDB), Informed Consent Forms, and/or Case Report Forms (CRFs).
• Performs review and clarification of trial-related Adverse Events (AEs), coding, and consistency in assessment.
• Conducts medical case review of Serious Adverse Events (SAEs), including coding, consistency, documentation, and patient narrative.
• Attends Kick-Off meetings, weekly team meetings, vendor meetings, and other meetings as needed or requested.
• Supports inspections and audits, acting as a subject matter expert for assigned programs.
• Provides training on product and medical review to vendor/team members as needed.
• Completes tasks on time or notifies the appropriate person with an alternate plan.
• Participates in the scientific literature review process for periodic safety reports, signal detection, and ad hoc needs.
• Attends/leads Safety committee meetings to support key decision-making, drive conclusions, and develop next steps.
• Works closely with Regulatory Affairs and other cross-functional team members to ensure oversight of critical safety issues and benefit-risk assessments.
• Participates in the development and maintenance of risk management plans and REMS as applicable.
• Serves as a key member of the Product Safety Committee, presenting safety issues, signal evaluations, and proposed risk mitigation strategies.
• Provides medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports.
• Contributes to the preparation of relevant regulatory documents and responses to regulatory agencies, IRBs, sites, and medical information queries.
• Provides consultation for medically related questions from participating vendors, affiliates, etc.
• Uses in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues.
• Develops/assists in the creation of internal SOPs and reviews vendor SOPs as needed.
• Supports on-site inspections and audits as needed.
• Expected to come on-site quarterly and ad hoc as needed.
• Performs other relevant duties as assigned.

Requirements

• MD from an accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent).
• Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting.
• Excellent scientific/clinical and analytical knowledge base, with the ability to assess data and understand safety/medical implications.
• Excellent oral and written communication skills, including the ability to present to large internal/external groups.
• Ability to multi-task and successfully manage multiple critical issues simultaneously.
• Ability to work productively in a high-pressure environment.
• Strong ability to understand and evaluate technical, scientific, and medical information; exposure to clinical data collection, assessment, and analysis.
• Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as implemented.
• Working knowledge of global drug development and pharmacovigilance guidelines and regulations.
• Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines.
• Excellent teamwork and collaboration skills.

Pay

The base salary pay range for this role is $228,000.00 - $313,000. Actual compensation packages will depend on various factors, including depth of experience, education, skillset, overall performance, and/or location.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.