Manager, Product Safety & Pharmacovigilance (Architecture)
The Product Safety & Pharmacovigilance Manager will perform activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds.
This can include but is not limited to, AE/SAE coding and/or review, narrative writing and/or review, ensure medical/scientific plausibility, ICSR submission to internal and external customers such as regulators.
The PSPV Manger will participate in Regulatory Authority Inspections and internal/ external audits as Subject Matter Expert (SME), providing responses to safety requests, and be available to respond to safety requests in-person as required.
Will manage the ARGUS Safety System and the PSPV Associates and Specialists.
DUTIES AND RESPONSIBILITIES
MINIMUM JOB REQUIREMENTS
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
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) Pharmacovigilance