Medical Director, Pharmacovigilance

Job Description

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.

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, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.

What You’ll Do :

• 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.
• Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company / vendor timelines.
• Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment.
• Provide 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.
• Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and / or Case Report Forms (CRFs).
• Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment.
• Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative.
• Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested.
• Support inspections and audits, act as a subject matter expert for the assigned program(s).
• Provide training on product and medical review to vendor / team members as needed.
• Completes tasks on time or notifies appropriate person with an alternate plan.
• Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed.
• 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 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.
• Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries.
• Provide consultation for medically related questions from participating vendors, affiliates, etc.
• Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues as appropriate.
• Develop / assist in creation of internal SOP and review vendor SOPs as needed.
• Support in 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.

What You'll Bring :

Deciphera offers competitive compensation and a comprehensive benefits package that includes the following :

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

J-18808-Ljbffr