Provides operational support for global pharmacovigilance activities for Clients investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data analysis and management obtained from the integrated database utilized by worldwide Clients pharmacovigilance personnel. Responsible for project implementation and execution of system, including responsibilities for providing safety ongoing business support and ongoing improvements. Key interface with the IT system administrators to verify and test system changes, ensuring that the system is compliant and meets business needs. The personnel who cover the workplace will develop their activities according to the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) and following the Pharmacovigilance legislation.
Responsibilities:
Coordinate and participate in the safety data analysis, review, processing and evaluation in order to prepare aggregate Process and review safety data to develop aggregate safety reports. Support to respond to requests from regulatory agencies. Coordinate and manage creation of queries for data extraction used in different PV documents. Develop training documentation and/or work instructions to determine methods and procedures. Work as Signal Analyst during signal management activities including extractions of signal detection reports ensuring document filing and archiving. Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities. Take part in self-inspection visits, audits, inspections and in CAPAs management. Coordination and management of aggregate safety reports submissions; notifies Regulatory Affairs and business partners accordingly. Interact with Regulatory Affairs Department as it relates to aggregate safety documents required by Regulatory Authorities. Review legislation to ensure compliance with local regulatory Authorities requirements. Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards. Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams. Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application. Gathering, prioritizing, and planning improvements based on user requests, taking into account overall regulations to the business. PV database operating activities Provide support in the updates in the database configuration of submission rules to Regulatory Authorities. Provide support in the updates in the database configuration of products and studies. Support drug safety applications with business administration tasks. Key project team technical expert to deliver solutions that are cost effective, sustainable, and meet business requirements Scientific and medical literature review Define with the Knowledge Services Department the strategy of scientific searches that are performed. Review scientific literature and bibliographic search results and determine the actions necessary to be taken therewith. Experience Drug Safety Analyst should ensure their knowledge of pharmacovigilance practices; existing legislation, regulations and guidelines; medical coding and safety-data administration. Drug Safety Analyst should have a university degree in health sciences/ biosciences and additional training in IT or have a university degree in IT with additional training and/or experience in pharmacovigilance. At least 2 years of relevant experience in pharmacovigilance and 2 years of relevant experience in managing databases, is usually required. Availability for international travelling when necessary is also required. Needed Skills Proven Self-starter with strong work ethic and the ability to exercise good judgment. Ability to work independently with minimum supervision. Must be proactive, results oriented, and have strong attention to detail. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment. Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings. Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines. Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word) - Familiarity with validation of computer systems and/or GMP environments is essential. Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA, WhoDrug is beneficial. Familiarity with reporting tools such as Business Objects is strongly preferred.
