Drug Safety Specialist II

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POST DATE 8/28/2016
END DATE 10/23/2016

Alkermes Waltham, MA

Waltham, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


td p span span span Alkermes plc is a fully integrated, global biopharmaceutical company developing /span span 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  a href="http://www.alkermes.com/" span span www.alkermes.com /span /span /a  . /span br br Position Summary: /span /span /p p span span The strong Drug Safety Specialist II /strong will have primary responsibility for the following: /span /span /p ul li span span 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. /span /span /li li span span 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. /span /span /li li span span 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. /span /span /li li span span Actively obtains follow-up through event resolution. Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion. /span /span /li li span span Performs continuous quality improvement initiatives to ensure data consistency across products and a high level of data quality.  /span /span /li li span span 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. /span /span /li li span span Interpret regulatory mandates. /span /span /li li span span Assist with internal and external drug safety audits. /span /span /li li span span Participate in clinical project teams and other interdepartmental teams supporting clinical studies; reviews and provide comments on study related documents. /span /span /li li span span 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. /span /span /li li span span 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.  /span /span /li li span span Identify and correct actions and facilitate, support, and implement as appropriate. /span /span /li li span span Review performance metric data and clarify inconsistencies and trends. /span /span /li li span span Address labeling concerns and updates /span /span /li li span span 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. /span /span /li li span span Other responsibilities as assigned /span /span /li /ul p span span strong Minimum Basic Qualifications : /strong /span /span /p ul li span span A clinical degree (e.g., RPh/PharmD, BSN, RN ) /span /span /li li span span 4+ years drug safety or clinical safety experience /span /span /li li span span Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge /span /span /li li span span Experience with Argus Safety System /span /span /li /ul