Medical Director, Pharmacovigilance

About the role

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

Responsibilities

• Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
• 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 that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment.
• Provides medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility.
• Affords assistance with development of the protocol, Investigative Drug Brochure (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.
• Performs medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative.
• Attends Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested.
• Supports inspections and audits, acts as a subject matter expert for the assigned program(s).
• Provides training on product and medical review to vendor/ team members as needed.
• Completes tasks on time or notifies appropriate person with an alternate plan.
• Participates in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed.
• Attends/leads Safety committee meeting 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 development and maintenance of risk management plans and REMS as applicable.
• Keys member on the Product Safety Committee; presentation of 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 preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site 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 as appropriate.
• Develops/assists in creation of internal SOP and reviews vendor SOPs as needed.
• Supports Inspections and Audits on-site, as needed.
• Expect to come on site on a quarterly basis, and ad hoc as needed.
• Other relevant duties as assigned.

Qualifications

• MD from 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 ability to assess data and understand the safety/medical implications
• Excellent oral and written communication skills including ability to present to large internal/external groups
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
• 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 they are 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

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $228,000.00 - $313,000.00. 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)

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.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

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.