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Clinical Drug Safety Manager - Emerging BioPharma / Complex Trials

Location
Raleigh, NC

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Job Description
Our client, an RTP area BioPharma undergoing tremendous growth, is actively recruiting for a highly competent and knowledgeable Clinical Drug Safety professional, to join its growing team. This company has several compounds with multiple indications in development in the oncology space. It has an expanding global presence and the future is extremely bright.



At this exciting phase of its development, it is essential that top-notch people are driving its Safety efforts. We seek a skilled and astute Safety professional to assume a lead role in the control and management of Safety and Pharmacovigilance information. Accurate, compliant and available Drug Safety information is essential. A top-notch candidate who combines broad and deep knowledge of Drug Safety/PV matters with the astute operational and technology savvy needed to ensure smart systems are developed and maintained.



Experience working on complex global trials (oncology, rare disease and cardiovascular) will be important here. This is a global operation that requires a candidate who understands the idiosyncrasies of worldwide Safety / PV matters.

This Manager will be the Subject Matter Expert on Drug Safety matters and will be managing the process and outsourced partners – not people.

Specific responsibilities will include:

• Manage the development and implementation of robust communication/interfacing processes with Safety Outsourcing Partner

• Represent Product Safety on clinical project teams contributing to the development and review of study-related documents (including protocols, investigator brochures, informed consents, case report forms, and clinical study reports)

• Assist in the development and maintenance of accurate risk profiles for products in development.

• Review processed cases to verify accuracy, consistency, and compliance. Conduct follow-up activities when needed.

• Maintain current knowledge of international adverse event reporting obligations

• Contribute to the development of Safety SOPs, standards and systems

• Support regulatory compliance with timelines for the delivery of information for reporting and other regulatory documents



Clinical research is largely outsourced. Seek a Safety Manager who is accustomed to working through CROs on Safety matters.



The ideal candidate will offer a BS in a medically related field, RN is preferred. 6 years of Drug Safety clinical experience. Knowledge of domestic and international Safety/PV regulations assumed and required. Current understanding regarding Safety Best Practices is equally important.


Other priorities include:

• Knowledge of ICH, FDA and Global Guidance and Regulations pertaining to Adverse Event Reporting and Drug Safety

• Experience working with 3rd party vendors for outsourced Safety functions

• Experience working in support of IND submissions



Finally and importantly, we seek a self-directed team player, a committed collaborator with a strong quality orientation and a “roll up your sleeves” mentality. This is a fast-paced, busy setting, a lot is happening and we seek a top-notch candidate who can hit the ground running.


This is a direct hire full-time position and a great opportunity for a skilled professional who seeks a challenging and rewarding position. Please forward resume for prompt consideration.



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