Director, Safety Science & PV Vendor Oversight

Director, Safety Science & PV Vendor Oversight page is loaded## Director, Safety Science & PV Vendor Oversightlocations:
US North Carolina Remote time type:
Full time posted on:
Posted 3 Days Agojob requisition :
JR100089
** COMPANY:
*** At Bio Cryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at
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* JOB SUMMARY:

**### Accountable for scientific leadership in pharmacovigilance and drug safety activities for assigned clinical studies, drug product development, and in the postmarking setting. Responsible for leading the ongoing safety surveillance, signal detection and management, and for providing pharmacovigilance and drug safety expertise to clinical and regulatory teams.### ### Additional responsibilities include oversight of affiliate and partner activities as they relate to pharmacovigilance regulations for Bio Cryst products.

Represents GDSP on internal launch or steering teams, drafts and drives to completion all pharmacovigilance agreements (PVAs) with affiliates, distributors, and licensing partners, and provides global pharmacovigilance support for Bio Cryst affiliate offices as required. Responsible for keeping GDSP abreast of all potential market expansions and product distribution plans. Assures that affiliates, pharmacovigilance partners, and distributors comply with global adverse event reporting requirements.
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* ESSENTIAL DUTIES & RESPONSIBILITIES:

*** Lead routine pharmacovigilance activities for a product or group of products, including aggregate data evaluation, signal detection and assessment, lead signal management process (i.e., signal tracking, review meetings, etc.).
* Prepare, author, and lead to completion the aggregate safety reports for assigned products, such as PSURs, PBRERs, DSURs, Pharmacovigilance Plans and Risk Management strategy and Plans.
* Collaborate with the Medical Director(s) in GDSP to ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
* Author signal evaluation reports, or sections of signal evaluation reports.
* Provide review of clinical protocols and study reports to ensure safety is addressed appropriately.
* In collaboration with the Medical Director(s), GDSP, lead safety contributions to the safety section of the Investigator’s Brochure (IB)/Company Core Data Sheet.
* Contribute to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission.
* Participate in or provide input for Drug Safety Monitoring Boards, as necessary.
* Conduct literature review for safety information and interaction with other groups to obtain necessary data (i.e., Medical Affairs, Clinical Development).
* Author responses to safety questions from regulatory authorities for assigned products.
* Contribute to and lead initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions, and vendor management as required.
* Take active part in Departmental activities based on strong safety/PV experience and expertise; examples include SOP, Work Instruction development, etc.
* Represent GDSP on commercial launch teams and initial steering committees for partnerships. Continued GDSP representation with affiliates, partners, and vendors after launch.
* Responsible for…