About the job
Join Deciphera Pharmaceuticals as a Medical Director of Pharmacovigilance, where you will play a pivotal role in ensuring the safety of our products. Reporting directly to the Senior Medical Director, this position is based in our Waltham office and is integral to our commitment to patient safety.
As a Medical Director, you will oversee global pharmacovigilance activities for both marketed and investigational products. Your responsibilities will include the comprehensive review and analysis of safety data, identification of safety signals, and management of the benefit-risk profile for assigned compounds. You will keep senior management informed about safety issues and may represent Deciphera at various internal and external meetings.
The ideal candidate will thrive in an entrepreneurial environment and demonstrate the flexibility to contribute to the safety understanding of our compounds throughout their lifecycle. You will engage with multiple levels of management and play a critical role in advancing our pharmacovigilance initiatives.
Key Responsibilities:
- Lead ongoing safety surveillance, benefit-risk assessments, and risk management for assigned products.
- Provide pharmacovigilance expertise to support decision-making based on risk/benefit evaluations and data analysis.
- Conduct medical reviews of adverse event reports for both marketed and investigational products, ensuring adherence to procedures and timelines.
- Ensure consistent and high-quality medical interpretation in adverse event case assessments.
- Support cross-functional teams with protocol-related medical guidance, including safety topics and patient eligibility considerations.
- Contribute to the development of protocols, Investigative Drug Brochures, Informed Consent Forms, and Case Report Forms.
- Review trial-related adverse events and ensure consistency in assessment.
- Participate in team meetings and vendor discussions as necessary.
- Support audits and inspections as a subject matter expert for assigned programs.
- Provide training to team members and vendors regarding product safety and medical review processes.
- Complete tasks in a timely manner, notifying relevant parties of any necessary changes.
- Engage in scientific literature review for periodic safety reports and signal detection.
