Medical Director, Pharmacovigilance

Found in: Resume Library US A2 - 6 days ago

Waltham Massachusetts, United States Deciphera Pharmaceuticals Full time
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.

The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.

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 as needed

Other relevant duties as assigned

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