Associate Director of Pharmacovigilance (Hartford)
Sumitomo Pharma, Hartford, Connecticut, United States, 06112
Join Sumitomo Pharma Co., Ltd., a leading global pharmaceutical company based in Japan, dedicated to addressing patient needs across various areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We are committed to accelerating the discovery, research, and development of novel therapies to bring valuable treatments to patients worldwide.
The Associate Director of Pharmacovigilance will play a crucial role as the central point of contact for global development and strategic partnership teams, leading comprehensive safety surveillance activities. This is an opportunity to influence safety governance for assigned compounds/products and make a difference in patient care.
Key Responsibilities:
Support drug safety governance by leading cross-functional Safety Management Teams in assessing drug safety profiles, and contributing to key safety documents including Investigator Brochures and regulatory reports.
Lead signal detection and evaluation, ensuring appropriate communication of safety information through established safety governance processes.
Maintain continuous updates of safety profiles and conduct ongoing risk/benefit assessments for assigned products.
Collaborate with various functions, representing Pharmacovigilance at Steering Committee meetings and other cross-functional forums.
Review adverse event reports and ensure high-quality assessment of case evaluations.
Conduct thorough reviews of coding and support key safety documents, including safety information for clinical studies.
Identify safety issues rapidly, escalating them as necessary through established governance structures.
Manage the preparation and presentation of safety reports and proposed risk mitigation strategies in internal meetings.
Contribute to the development of Risk Management documents and other key internal safety documents.
Collaborate with team members to effectively manage the benefit/risk profile of assigned products, ensuring the highest level of patient safety.
Participate in literature monitoring and ensure integration of findings into safety signal detection efforts.
Assist in aggregate safety report activities, contributing to data analysis and report writing.
Coordinate the response to urgent safety questions from regulatory authorities and healthcare professionals.
Serve as a subject matter expert within the Pharmacovigilance domain and support compliance with internal standards and regulations.
Essential Qualifications: A minimum of 8 years of experience in Pharmacovigilance and Risk Management is required.
Prior experience in the oncology field is preferred.
Experience in early-phase development is advantageous.
Demonstrated leadership or project management experience is strongly preferred.
Excellent communication skills, both written and spoken, in English.
Proven ability to work independently, prioritize tasks, and manage multiple projects efficiently.
The base salary for this role is competitive, ranging from $155,000 to $193,800. This is part of our comprehensive rewards package, which includes merit-based increases, a short incentive plan, 401(k) plan participation, and extensive health insurance options. We also have a generous time-off policy that includes flexible paid time off, 11 paid holidays, and additional time off during a designated closure period at the end of December. At Sumitomo Pharma, we strive for a culture that prioritizes patient safety and ethical practices. We welcome applicants from diverse backgrounds and are committed to equal employment opportunities. We look forward to your application and the possibility of you joining our mission to improve healthcare and enhance the lives of people around the world.
Lead signal detection and evaluation, ensuring appropriate communication of safety information through established safety governance processes.
Maintain continuous updates of safety profiles and conduct ongoing risk/benefit assessments for assigned products.
Collaborate with various functions, representing Pharmacovigilance at Steering Committee meetings and other cross-functional forums.
Review adverse event reports and ensure high-quality assessment of case evaluations.
Conduct thorough reviews of coding and support key safety documents, including safety information for clinical studies.
Identify safety issues rapidly, escalating them as necessary through established governance structures.
Manage the preparation and presentation of safety reports and proposed risk mitigation strategies in internal meetings.
Contribute to the development of Risk Management documents and other key internal safety documents.
Collaborate with team members to effectively manage the benefit/risk profile of assigned products, ensuring the highest level of patient safety.
Participate in literature monitoring and ensure integration of findings into safety signal detection efforts.
Assist in aggregate safety report activities, contributing to data analysis and report writing.
Coordinate the response to urgent safety questions from regulatory authorities and healthcare professionals.
Serve as a subject matter expert within the Pharmacovigilance domain and support compliance with internal standards and regulations.
Essential Qualifications: A minimum of 8 years of experience in Pharmacovigilance and Risk Management is required.
Prior experience in the oncology field is preferred.
Experience in early-phase development is advantageous.
Demonstrated leadership or project management experience is strongly preferred.
Excellent communication skills, both written and spoken, in English.
Proven ability to work independently, prioritize tasks, and manage multiple projects efficiently.
The base salary for this role is competitive, ranging from $155,000 to $193,800. This is part of our comprehensive rewards package, which includes merit-based increases, a short incentive plan, 401(k) plan participation, and extensive health insurance options. We also have a generous time-off policy that includes flexible paid time off, 11 paid holidays, and additional time off during a designated closure period at the end of December. At Sumitomo Pharma, we strive for a culture that prioritizes patient safety and ethical practices. We welcome applicants from diverse backgrounds and are committed to equal employment opportunities. We look forward to your application and the possibility of you joining our mission to improve healthcare and enhance the lives of people around the world.