Clinical Safety Physician Lead
1 week ago
About the Role
We are seeking a highly skilled Clinical Safety Physician Lead to join our team at BioCT Innovation Commons. In this role, you will be responsible for leading pharmacovigilance risk management activities on a global level.
As a key member of our team, you will develop proactive risk management strategies for assigned marketed and/or investigational compounds. You will set and align standards across products/compounds within the assigned portfolio, ensuring compliance with regulatory requirements.
You will plan, manage, perform, and monitor all pharmacovigilance activities for assigned drug responsibilities, including continuous monitoring and further development of the product safety profile, safety issue management, and close collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studies.
You will also review and provide medical-scientific input to regulatory documents such as Safety components of submission documents for global marketing authorization, Periodic Benefit Risk Evaluation Reports/PADERs, Development Safety Update Reports, Risk Management Plans, and Clinical Overview Statements.
The ideal candidate will have a strong leadership background, excellent interpersonal and communication skills, and the ability to synthesize large amounts of medical data. You should have a thorough understanding of Pharmacovigilance regulation in major markets and respective need for compliance.
This is an exceptional opportunity to contribute to the discovery, development, and delivery of innovative treatments to patients and customers worldwide.
About Our Company
BioCT Innovation Commons is a world-renowned organization dedicated to advancing human health through cutting-edge research and innovation. We foster a collaborative environment where talented individuals can thrive and make a meaningful impact.
Key Responsibilities
- Develop and implement pharmacovigilance risk management strategies for assigned compounds
- Lead cross-functional teams to ensure compliance with regulatory requirements
- Collaborate with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studies
- Review and provide medical-scientific input to regulatory documents
- Maintain a thorough understanding of Pharmacovigilance regulation in major markets and respective need for compliance
Requirements
- US MD or DO degree or international equivalent from an accredited institution
- Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (5) years, and a minimum of two (2) years of experience in the pharmaceutical industry or equivalent required
- One to three (1-3) years of leadership experience (e.g. projects, teams, initiative) and influencing teams required
- Potential for people leadership required
Compensation and Benefits
This position offers a competitive salary range between $163,000 and $350,000. Additionally, you may be eligible for a role-specific variable or performance-based bonus and/or other compensation elements.
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