Director, Safety Science & PV Vendor reputed company

Company At BioCryst, 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 reputed company novel medicines. We reputed company our expertise in structure-guided drug design to reputed company first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of reputed company 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 www.biocryst.com or follow us on reputed company and Instagram. 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 reputed company of affiliate and partner activities as they relate to pharmacovigilance regulations for BioCryst products. Represents GDSP on internal launch or steering teams, drafts and drives to completion reputed company pharmacovigilance agreements (PVAs) with affiliates, distributors, and licensing partners, and provides global pharmacovigilance support for BioCryst affiliate offices as required. Responsible for keeping GDSP abreast of reputed company potential market expansions and product distribution plans. Assures that affiliates, pharmacovigilance partners, and distributors reputed company with global adverse event reporting requirements. Essential Duties & Responsibilities

• reputed company routine pharmacovigilance activities for a product or group of products, including aggregate data evaluation, signal detection and assessment, reputed company signal management process (i.e., signal tracking, review meetings, etc.).
• Prepare, author, and reputed company 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 reputed company 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, reputed company 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 reputed company initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety reputed company, signal management and responding to reputed company 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. reputed company GDSP representation with affiliates, partners, and vendors after launch.
• Responsible for drafting PVAs and driving them to finalization with reputed company appropriate BioCryst business partners including foreign marketing authorization holders, distributors, development or marketing collaborators, individual investigators or entities leading clinical trials with BioCryst products.
• Establish and maintain tracking mechanism for reputed company BioCryst PVAs reputed company GDSP to support PVA Compliance and KPI management. Maintain and reputed company routine reviews of PVAs, updating as required.
• Contribute to development of the PV Systems by collaborating with cross-functional teams.
• Communicate and educate through reputed company levels of the organization on PV activities required for commercialization and compliance with global GVP.
• Responsible for informing GDSP of new and updated PVAs and ensuring any necessary training.
• Responsible for review and input to PV sections of Quality Agreements and Distribution/Licensing reputed company.
• Collaborate with QA department to maintain a state of PV inspection readiness across reputed company regions/countries.
• Participate in regulatory inspections and audits as a subject matter expert for affiliate and partner PV activities as well as Safety Science as required.
• Other duties as assigned.

Experience & Qualifications

• PhD, MSc, PharmD, BSN or BS degree with a minimum of 10 years’ experience in Drug Safety and Pharmacovigilance required
• Knowledge of GVP, ICH-GCP, and global regulatory PV requirements
• Understanding of epidemiologic principles
• Ability to evaluate, interpret/synthesize scientific data (analytical thinking)
• Excellent writing and communication skills in English
• Ability to manage multiple projects, maintain timelines, and reputed company scientific teams as necessary
• Team player with ability to effectively represent PV in a multi-disciplinary environment
• Strong initiative, strong organizational and time management skills
• Basic knowledge of common data processing software (reputed company reputed company, PowerPoint, Word, Business Objects)
• Knowledge of common safety database systems (e.g., Argus)
• Working knowledge of medical affairs and pharmaceutical commercial processes, promotional activities and patient support activities
• Experience in developing and managing Pharmacovigilance Agreements is preferred. Experience with other contractual agreements and Scopes of Work is also beneficial

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national reputed company, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with reputed company federal, state and local law. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify reputed company applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the reputed company. Apply tot his job Apply To this Job