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Global Pharmacovigilance and Medical Director
2 months ago
Deciphera Pharmaceuticals is seeking a highly skilled and experienced Medical Director to lead our Pharmacovigilance and Safety efforts. As a key member of our team, you will be responsible for ensuring the safe and effective use of our products, and for identifying and mitigating potential safety risks.
Key Responsibilities- Pharmacovigilance and Safety Leadership: Provide strategic direction and oversight for pharmacovigilance and safety activities, including the review and analysis of safety data from post-marketing sources and clinical trials.
- Safety Signal Detection and Investigation: Identify and investigate potential safety signals, and develop and implement risk management plans to mitigate these risks.
- Benefit-Risk Assessment: Conduct benefit-risk assessments for assigned products, and provide recommendations to senior management on product safety and risk management.
- Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines related to pharmacovigilance and safety, including those of the FDA and EMA.
- Team Leadership: Lead and manage a team of pharmacovigilance and safety professionals, providing guidance and oversight to ensure the successful execution of safety-related activities.
- Medical Degree: MD from an accredited institution of medical education (board certified preferred; board eligible or OUS equivalent).
- Pharmacovigilance Experience: Minimum of 5 years of experience in pharmacovigilance and drug safety, with a strong background in safety signal detection and investigation.
- Scientific and Analytical Knowledge: Excellent scientific and analytical knowledge base, with the ability to assess data and understand the safety and medical implications.
- Communication and Leadership Skills: Excellent oral and written communication skills, including the ability to present to large internal and external groups, and strong leadership and team management skills.
- Competitive Compensation: Deciphera offers a competitive compensation package, including a base salary, bonus, and comprehensive benefits.
- Opportunities for Growth: We offer opportunities for professional growth and development, including training and education programs, and a collaborative and dynamic work environment.
- Recognition and Rewards: We recognize and reward our employees for their contributions and achievements, through a range of recognition and reward programs.
