Job Title

Job DescriptionJob DescriptionProvides operational support for global pharmacovigilance activities for 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 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 legislationResponsibilities:Coordinate and participate in the safety data analysis, review, processing and evaluation in order to prepare aggrega1. Process and review safety data to develop aggregate safety reports2. Support to respond to requests from regulatory agencies3. Coordinate and manage creation of queries for data extraction used in different PV documents4. Develop training documentation and/or work instructions to determine methods and procedures5. Work as Signal Analyst during signal management activities including extractions of signal detection reports ensuring document filing and archivingEnsure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities.1. Take part in self-inspection visits, audits, inspections and in CAPAs management2. Coordination and management of aggregate safety reports submissions; notifies Regulatory Affairs and business partners accordingly3. Interact with Regulatory Affairs Department as it relates to aggregate safety documents required by Regulatory Authorities4. Review legislation to ensure compliance with local regulatory Authorities requirements5. Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards6. 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 diagrams7. Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application8. Gathering, prioritizing, and planning improvements based on user requests, taking into account overall regulations to the businessPV data base operating activities1. Provide support in the updates in the database configuration of submission rules to Regulatory Authorities2. Provide support in the updates in the database configuration of products and studies3. Support drug safety applications with business administration tasks. Key project team technical expert to deliver solutions that are cost effective, sustainable, and meet business requirementsScientific and medical literature review1. Define with the Knowledge Services Department the strategy of scientific searches that are performed2. Review scientific literature and bibliographic search results and determine the actions necessary to be taken therewithExperience: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 data bases, 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.Pay Rate Range: $30-45/hr depending on experience Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.