Job Description :
Job Title : Subject matter expert Argus+ ARIS - LS Job Type : Contract Location NJ/PA Job Description : PV Subject matter expert processing, Pharmacovigilance and Regulatory Technical skill - Argus+ ARISg experience. Position Overview Work with clients in the Regulatory Affairs space to help them transform their Business landscape. As a Senior Manager you would be responsible for: Job Functions Learn and develop a point of view on latest regulatory changes coming in from FDA, EMA, MHRA, JMDA and other global regulators Interpret the impact of these changes to Safety & PV across Pharma, Medical Device and Vaccines industry Publish your thinking through whitepapers, blogs, webinars etc. Identify opportunities within our existing client base working with account teams Understand Safety & PV landscape of our clients Understand their strategic objectives and initiatives to achieve the objectives Introduce Cognizant's point of view, expertise to enable customers make business and technology decisions Builds strong professional working relationships across all levels within the client organization. Establishes a high level of personal credibility as a trusted advisor to key client Safety & PV Business & IT teams. Deeply understand client Safety & PV strategies and challenges to develop account penetration strategies and execute them effectively Be part of client engagements and deliver Safety & PV transformation, tool / platform selection, implementation, upgrade, migration and other operational excellence initiatives Work with tool vendors like Veeva, Oracle and Aris Global to understand their platform capabilities Develop a point of view on platform selection Work with clients in their journey to select and implement / upgrade platforms Requirements Proven Safety & PV consulting experience in the industry, a significant amount of which should have been spent on implementing platforms like Oracle Argus & Aris Global LSMV Good understanding of the Life Sciences R&D domain, with 10+ years operating in this area Ability to develop value proposition to deliver highest value to the customer Customer orientated and ability to keep on top of all progress and potential risks across the engagement and client landscape Knowledge and experience in delivering solutions and services with 21CFR Part 11/GxP compliance Experience working for a Pharma/Device/Vaccines organization in their R&D department with good understanding of Clinical, Regulatory and Safety processes Past experience delivering Safety & PV IT consulting services Excellent understanding of end-to-end Safety & PV processes Other Skills/Abilities Credible client engagement skills across all levels with Client organization Strong leadership skills Excellent communication and inter-personal skills are critical Highly organized and effective communicator Reliable and dependable Natural ability to build customer rapport Self-motivation and ambition Analytical and able to assimilate information quickly Proven ability to develop and close business opportunities