Subject Matter Expert:SME_DE06US009

Position Summary

ArisGlobal, LLC. (Waltham, MA) needs Sr. Subject Matter Expert:

The primary function of the Subject Matter Expert (SME) role is to bring customer facing, inward facing and industry thought leadership experience to ArisGlobal’s drug safety offerings. Create drug safety-related procedural documents and Standard Operating Procedures (SOPs) incompliance with regulatory requirements. Provide Drug safety and pharmacovigilance expert knowledge to global delivery teams in support of the company's primary mission of expanding revenue opportunities in line with the overall company strategy. Provide Drug safety knowledge to potential customers (Global pharmaceutical companies, government health authorities etc.,) and assist them in overcoming resistance in the drug safety industry to certain regulatory techniques. Involve in supporting the developing and designing of the tools such as drug safety clinical database tools, Literature Database, Risk management tool for medical science use and for analyzing the safety and efficacy of drug, device & vaccines in compliance with health regulatory authority guidelines. Provide the expert knowledge to customers in implementation of the safety database for processing serious and non-serious adverse event cases related to clinical trials Drugs, medical devices and vaccines and submitting them to the regulatory health authorities. Develop and authorize the safety database - data entry guidelines, standard operating procedures (SOPs) & safety related procedural documents as per the clinical trial and post marketing regulatory guidelines. Responsible for solidifying and extending capabilities to help support drug safety committees in their decision-making. Acting as the safety functional lead and ensuring that projects run on time, on budget, and in accordance with contracts, SOPs, quality standards, and regulatory guidelines. Assist in project initiation and planning including proposal development, contract process, and creation of safety management plan (covering safety processing and expedited reporting of individual and aggregate reports). Liaise with internal (e.g., business operations, trainings management team, account management) and external stakeholders (e.g., customers, third party vendors, health authorities). Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate. Working with different individuals involved, assisting in the ongoing projects related to the Safety suite as well as the creation of new offerings in the area of risk management. To keep up to date with the Food and Drug Administration (FDA) and other Regulatory Agencies guidelines regarding applications of electronic, patient-level databases and other emerging research tools. Working with identified industry partners and continue to monitor and provide input into the delivery teams development process of the safety product. Train the team members with the Safety database procedures and steps to process and submit serious adverse events in compliance with regulatory requirements to regulatory authorities like FDA etc. Provide support in Safety signaling and LifeSphere Business Intelligence process and procedures in compliance with regulatory requirements.

Travel/relocation to various unanticipated client sites within the United States only is required.  Exact client site location and frequency of travel cannot be predicted as it may vary/change depending on project availability.

Education

Must have a Master’s Degree in Biotechnology, Engineering or any related field.

Your Experience

Must have at least 2 years of experience as Drug Safety Specialist, Project Leader, or related. 

Special Requirements

Must have 2 years of experience using: Argus Safety Database, ArisG patient safety database, Safety Database Migrations, Wis, SOPs, Pharmacovigilance reporting tool, Signal Detection Tool, Literature Surveillance tool, LifeSphere MultiVigilance (LSMV) database.

RATE OF PAY

$133,494.00 per year