BioCryst Pharmaceuticals
Product Safety Associate - Postmarketing (Contract)
BioCryst Pharmaceuticals, Durham, North Carolina, United States, 27703
DescriptionJOB SUMMARY:The ideal candidate is responsible for supporting postmarketing safety operations with adverse event (AE) case processing tasks, especially regarding initial receipt and triage of information received in the postmarketing safety mailbox. This role is primarily responsible for receiving, tracking and organizing incoming postmarketing safety information from all sources globally. The role may also assist with data entry of postmarketing cases during times of high demand.
#LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:* Monitors the electronic safety mailbox to include identifying, tracking, and filing postmarketing safety information.* Ability to book-in, track, and initiate data entry of postmarketing adverse event reports from all sources globally.* Exposure to writing comprehensive case narrative and integrate case related information including medical conditions, lab results, and diagnostic procedures.* Demonstrates working knowledge of MedDRA to ensure proper coding of adverse event reports.* Performs follow up activities as required for postmarketing AE cases, including monitoring the status of outstanding queries.* Coordinates quality control review and medical review of individual cases with the appropriate GDSP Sr. PSA and Medical Director.* Assists with case exchange reconciliation processes with external vendors and licensing partners, as well as product complaint reconciliation with the BioCryst Quality Department.* Assists with adverse event reconciliation processes with external vendors and licensing partners, as well as product complaint reconciliation with the BioCryst Quality department.* Ensures filing of adverse event and other safety documentation (such as literature reviews) received from safety vendors and partners in the departmental shared drives.* Assists with monitoring and tracking of ICSR submissions as well as periodic/aggregate report submissions for all products.* Assists with monitoring and tracking of ICSR submissions for all marketed products.* Contributes to inspection readiness activities as needed.* Maintains knowledge of current global pharmacovigilance guidelines and regulations. Knowledge of Good Pharmacovigilance Practices (GVP).* May assist with collecting information needed to keep the PSMF current and interact with the QPPV office to provide QPPV requested documentationEXPERIENCE & QUALIFICATIONS:* Bachelor's degree with a focus in a scientific field, or equivalent combination of experience and education.* At least 2 years of relevant industry experience, of which at least 1 year of pharmaceutical industry (sponsor) experience in pharmacovigilance strongly preferred.* At least 1 year of experience with spontaneous (postmarketing) and solicited AE case processing* Working knowledge of safety databases (e.g., Argus) and ability to conduct accurate safety database searches with minimal supervision.* High degree of accuracy and attention to detail.* Knowledge of international regulations regarding postmarketing adverse event reporting; knowledge of EU PV regulations (e.g., GVP) preferred.* Excellent oral and written communication skills.* Ability to successfully function in a rapidly changing environment.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 origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
#LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:* Monitors the electronic safety mailbox to include identifying, tracking, and filing postmarketing safety information.* Ability to book-in, track, and initiate data entry of postmarketing adverse event reports from all sources globally.* Exposure to writing comprehensive case narrative and integrate case related information including medical conditions, lab results, and diagnostic procedures.* Demonstrates working knowledge of MedDRA to ensure proper coding of adverse event reports.* Performs follow up activities as required for postmarketing AE cases, including monitoring the status of outstanding queries.* Coordinates quality control review and medical review of individual cases with the appropriate GDSP Sr. PSA and Medical Director.* Assists with case exchange reconciliation processes with external vendors and licensing partners, as well as product complaint reconciliation with the BioCryst Quality Department.* Assists with adverse event reconciliation processes with external vendors and licensing partners, as well as product complaint reconciliation with the BioCryst Quality department.* Ensures filing of adverse event and other safety documentation (such as literature reviews) received from safety vendors and partners in the departmental shared drives.* Assists with monitoring and tracking of ICSR submissions as well as periodic/aggregate report submissions for all products.* Assists with monitoring and tracking of ICSR submissions for all marketed products.* Contributes to inspection readiness activities as needed.* Maintains knowledge of current global pharmacovigilance guidelines and regulations. Knowledge of Good Pharmacovigilance Practices (GVP).* May assist with collecting information needed to keep the PSMF current and interact with the QPPV office to provide QPPV requested documentationEXPERIENCE & QUALIFICATIONS:* Bachelor's degree with a focus in a scientific field, or equivalent combination of experience and education.* At least 2 years of relevant industry experience, of which at least 1 year of pharmaceutical industry (sponsor) experience in pharmacovigilance strongly preferred.* At least 1 year of experience with spontaneous (postmarketing) and solicited AE case processing* Working knowledge of safety databases (e.g., Argus) and ability to conduct accurate safety database searches with minimal supervision.* High degree of accuracy and attention to detail.* Knowledge of international regulations regarding postmarketing adverse event reporting; knowledge of EU PV regulations (e.g., GVP) preferred.* Excellent oral and written communication skills.* Ability to successfully function in a rapidly changing environment.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 origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)