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
Ensure accurate transfer of information from initial and follow-up source documents for adverse event reports to appropriate fields within ARGUS; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the ARGUS workflow to meet local and global regulatory timelines.
Participate in Signal Management Activities by scheduling SMT meetings, generating line listings from Argus (Safety Database) and EDC (Clinical Database), prepare and distribute SMT meeting material and SMT meeting minutes.
Process case-related information including interpretation of medical conditions, lab results, and procedures; ensuring proper coding of data into the global safety database.
When required, perform timely and accurate triage of adverse event reports, complaints, & inquiries from physicians, pharmacies, consumers and sales reps.
Participate in Literature review process. Setup and review literature search criteria in Ovid, and review Literature search results weekly for appropriate reporting and collection of safety information for both marketed and development products.
Lead the preparation of PADER/PBRER, including calls for contribution, maintain PADER/PBRER schedule, coordinate document preparation/submission with Regulatory for electronic submissions.
Work closely with the Drug Safety case processing team to ensure consistent data entry processes across all products.
Participate in updating the data entry manual and associated work instructions when new and/or updated conventions are introduced and train the staff as appropriate.
Participate in QA related tasks for ICSRs (i.e., review of cases, case corrections, compilation of data, presentations to staff).
Author, revise, review PSPV Standard Operating Procedures, Work Instructions and Job Aids, as needed.
May represent Product Safety & Pharmacovigilance in project team meetings.
Review clinical protocols to identify impact on safety database, and initiate change requests as appropriate.
Manage PV documentation (i.e., training records, agreements, and training materials) on shared sites for commercial programs that involve safety data collection/reporting
Manage PVA and provide training to external partners/vendors from safety perspective.
Participate in Regulatory Authority Inspections (FDA and AIFA) and internal/ external audits as Subject Matter Expert (SME); provide responses to safety requests, and be available to respond in-person as required
Manage the workload and assignments of the PSPV staff.
MINIMUM JOB REQUIREMENTS
Bachelor’s degree and a minimum of 5 years of experience in supporting Drug Safety case management processes in a pharmaceutical company, or equivalent.
Must have a good understanding of Drug Safety regulations specifically US FDA and the EU GVPs.
Must have experience working with standard safety software, with preference for Argus Safety.
Familiarity with signal detection and pharmacovigilance processes a plus.
Familiarity with SQL and relational databases a plus.
Should be proficient in case management activities of clinical, post marketing products and literature cases
Ability to offer knowledge in end-to-end processing of Individual Case Safety Report (ICSRs) including triage, data entry, medical coding and narrative writing.
Experience assessing the level of seriousness, expectation and causality of adverse events.
Ability to perform quality review of non-serious and serious cases.
Strong understanding of clinical trial methodology, GCP and medical terminology.
Experience corresponding with health care professionals, consumers, and company personnel regarding safety issues with marketed products.
Experience corresponding with and communicating with CRO’s regarding collection of safety information for development products.
Experience assisting with reconciliation activities with internal departments and external partners when required.
Experience participating in clinical team meetings supporting the Shionogi development portfolio as representative of PSPV group.
Prior experience with computerized systems validation preferred.
Must be proficient in Microsoft Excel, Word, and PowerPoint; familiarity with MS Project is preferred.
Must have strong analytical and problem-solving skills, with the associated curiosity to enable solving complex problems with little assistance.
Must be self-motivated, detail oriented and able to multi-task.
Must possess excellent communication (oral and written) skill regarding both medical and technical topics.
Must have strong interpersonal/organizational skills.
Must maintain superior customer service at all times with all users.
Must possess the ability to work in a team environment and follow written policies/procedures.
Must be comfortable in a fast-paced, demanding work environment.
Flexibility to work outside of normal working hours or on-call arrangements to support the global drug safety organization.
While able to work from home, should live a commutable distance to our offices in Florham Park, New Jersey.
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)