Drug Safety Specialist II
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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
The Drug Safety Specialist II will have primary responsibility for the following:
* Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable licensing or partnership agreements.
* Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently.
* Perform verification of safety data and will utilize clinical judgment in coding of verbatim adverse events, medical history and medications. Ability to synthesize complex clinical information into accurate and complete reports.
* Actively obtains follow-up through event resolution. Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion.
* Performs continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality.
* Contributes in the conduct of ongoing safety surveillance for marketed and investigational products. Assist with the identification and evaluation of events of special interests as well as aggregate data review.
* Interpret regulatory mandates.
* Assist with internal and external drug safety audits.
* Participate in clinical project teams and other interdepartmental teams supporting clinical studies; reviews and provide comments on study related documents.
* Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites; interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal.
* Contributes in the development and writing of industry standard operating procedures and processes for pharmacovigilance activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports.
* Identify and correct actions and facilitate, support, and implement as appropriate.
* Review performance metric data and clarify inconsistencies and trends.
* Address labeling concerns and updates
* Assist in responding to queries from health authorities or outside sources; Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, PSUR, or clinical study reports.
* Other responsibilities as assigned
Minimum Basic Qualifications :
* A clinical degree (e.g., RPh/PharmD, BSN, RN )
* 4+ years drug safety or clinical safety experience
* Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge
* Experience with Argus Safety System
* Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidances related to pharmacovigilance and Good Clinical Practices
* Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
* Knowledge of clinical trial database (e.g. Trialmaster) is a plus
* Ability to work effectively as an individual contributor and as project team safety representative
* Is proactive, demonstrate ability to independently identify problems and effectively offer solutions
* Has the ability to work independently and multi-task with attention to detail,
* Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.