We are looking for a proactive PV Officer and/or Senior PV Associate to work within the Clinigen Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work We are looking for applicants based in Central and Eastern Europe (remote), Malaysia and South Africa. **Key Responsibilities:** - Working within the Pharmacovigilance Operations team - Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database - Support quality and efficiency strategies within the organisation - Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required - Contributes to improvements of team processes. - Other PV operational activities or initiatives as assigned - Maintaining good client relations and ensuring a consistently high quality of work for each client. - Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured. **For the Clients** - Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses - Triage, tracking and forwarding of safety data from client Managed Access Programmes. - Case processing of SAEs and/or ICSRs - Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities - Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments. - Supporting investigation of cases of non-compliance of SAEs/ICSRs - Performing Literature Article reviews - Performing follow-up related to queries and requests regarding case handling - Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs - Performing quality-control of cases in the Global Drug Safety database - Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG) - Assists when required in Partner, Health Authority Audits/Inspections. - Participation in Client audits and inspections **Additional Duties** - The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved; - Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities - It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded

• Lead and support migration of batch scheduling workloads to IBM Z Workload Scheduler. • Analyze legacy scheduling definitions from CA-7, CA ESP, Jobtrac, BMC Control-M, and ASG Zeke/Zebb and map them to IBM scheduler structures. • Execute parallel tracking, schedule validation, dependency analysis, and issue resolution. • Monitor workload execution using TSO/ISPF and IBM scheduler interfaces. • Provide technical guidance and training to scheduling teams and operational staff.

• Install and deploy IBM PD tools following best practices and customer requirements. • Support migration activities involving conversion and integration of IBM and ISV problem-determination tools. • Provide training sessions, workshops, and technical presentations for customers and internal teams. • Perform problem determination and resolution for IBM products in customer environments. • Work across DB2, CICS, and IMS environments as part of installation, deployment, and migration support.

• Prepare prior authorization requests received by validating prescriber and member information, level of review, and appropriate clinical guidelines • Make outbound calls to providers to obtain additional clinical information to ensure substantial clinical information exists to reach a clinical determination for pharmacist review • Proactively obtains clinical information from prescribers, referral coordinators, and appropriate staff to ensure all aspects of clinical guidelines are addressed for pharmacist review. • Review and analyze pharmacy claims data for proactive outreach and intervention. • Identify, document, and escalate provider concerns to the appropriate internal team including various members of the Prior Authorization Team • Triage phone calls from members, pharmacy personnel, and providers by asking applicable drug and client specific clinical questions. • Effectively communicate issues and resolutions to members, pharmacy staff, providers, and appropriate internal stakeholders. • Follow all internal Standard Operating Procedures and adhere to HIPAA guidelines and Company policies • Ensure customer satisfaction, extraordinary customer care, and quality resolution with genuine compassion in a fast paced, startup environment