Senior Director, Drug Safety and Pharmacovigilance Operations Specialist
16 hours ago
Leap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance Operations team. As a key member of our safety organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning and implementation of safety operational activities.
Key Responsibilities- Develop and implement pharmacovigilance strategies and operational plans to ensure compliance with regulatory requirements.
- Lead and manage a team of pharmacovigilance professionals, providing guidance and oversight to ensure high-quality safety reporting and adverse event management.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure seamless integration of safety activities into overall product development.
- Develop and maintain relationships with vendors and partners to ensure effective outsourcing of pharmacovigilance activities.
- Ensure compliance with Good Pharmacovigilance Practice (GVP) and relevant regulatory guidelines, including ICH, FDA, and EMA regulations.
- Contribute to the development and implementation of safety policies, procedures, and training programs.
- Support the development and submission of regulatory documents, including DSURs, IBs, and PBRERs/PADERs.
- Collaborate with the Head of Pharmacovigilance to develop and implement a safety signal management program.
- Support the development and maintenance of safety databases, including ARGUS, ARISg, and other safety database applications.
- Bachelor's or advanced degree in a life science, nursing, pharmacy, or other healthcare-related profession.
- Minimum 10 years of experience in pharmacovigilance operations, with at least 5 years in a management position overseeing business process outsourcing vendors and relationships.
- Experience with safety databases, electronic data capture systems, and electronic document management systems.
- Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations.
- Strong analytical and problem-solving skills, with attention to both strategy and detail.
- Excellent verbal, written technical communication, and presentation skills.
- Ability to work effectively in a fast-paced team environment and with individuals at all levels within the organization.
Leap Therapeutics is a biotechnology company focused on developing targeted and immuno-oncology therapeutics. Our most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. We are committed to advancing innovative treatments for patients with cancer and other serious diseases.
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Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryLeap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance Operations team. As a key member of our safety organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning and implementation of safety...
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Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryLeap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance Operations team. As a key member of our safety organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning and implementation of safety...
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Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Pharmacovigilance and Safety Operations team at Leap Therapeutics. As a key member of our organization, you will be responsible for overseeing the operational aspects of pharmacovigilance, ensuring compliance with regulatory guidelines, and driving strategic planning to...
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