Pharmacovigilance Case Management Oversight Specialist

Job Description

Job title : Pharmacovigilance Case Management Oversight Specialist Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities The primary function of the PV Case Management Oversight specialist is to review end-to-end ICSR management process and ensure its seamless operation. This role includes evaluation of cases submitted to FDA/EMA/MHRA. Below is the detailed responsibility. This role contributes to safety management activities in cooperation with OPELLA CSE PV, Country PV team, Health Authorities (Has), partner companies and other functions in compliance with global procedures and local regulatory PV requirements. Liaise with CHC Country Safety Head (CSH), CHC GRA and CSE PV case management vendors on an ongoing basis to achieve compliance to the HA PV requirements. Responsible for overseeing Inbound & outbound management of the ICSRs of specified HAs. Review and improve/streamline the oversight case management process for specified HAs. Responsible for overseeing timely submissions of ICSRs/ PV reports to the HA as per regulations. Responsible & accountable for oversight of Tasks and Correspondence within Safety DB to ensure compliance is met regarding follow-up letters, corrections etc. Provide Quality oversight of the follow-up letter package for data entry created by vendors through retrospective Quality Review (i.e. Tasks and Correspondence from previous week to be reviewed in the current week). Documentation of discrepancies in the follow-up letter package Responsible for implementing CAPAs for late cases and audit/inspection findings from respective HAs. Liaison with QPPV Office for case management (CM) related activities. Responsible for Case management related QDs/Job aids management. Manage and Oversee Distributor related activities for Case Management Additional Activities For US Case Management Oversight Specialist This role is responsible to oversee the implementation and management of the overall AE case processing & DB management operation in the US including but not limited to CM for marketed CHC products, safety evaluation, Food and Drugs Administration (FDA) reporting, PTC management of medical device/drug device combination products, PV inspection/ audit and outsourcing vendor management. Support US case processing operations including PTC management with medical device/drug device combination product Responsible for managing USPV Mailbox and reconciliation of inbound reports in USPV Mailbox with the reports entered in Safety DB, and documentation of discrepancies. Processing and documentation of USPV Mailbox source document requests. Other PV tasks as required. Additional Activities For EMA/MHRA Case Management Oversight Specialist Oversee downloading of the cases from Eudravigilance (EV) and creation of these cases in safety DB for Medical Literature Monitoring (MLM) and National Competent Authority (NCA) ICSRs. Oversee EMA and MLM related product list for Opella. Interact with Literature team for MLM related activities Responsible for oversight of E2B submissions for EMA ICSRs. Responsible to maintain and improve EMA device related activities Responsible to oversee case intake and submission for EMA G2 countries with no CSHs. Coordinate with European Union (EU) Countries for oversight of any Local HA related Activities (ex. submissions, etc.) Responsible for configurations of EMA related Clinical Trials in Safety DB. Responsible for ensuring CPD is update for fulling foreign case submission requirements. Any other EMA oversight Activities for PV Ops. To solicit local regulatory obligations from appropriate SMEs and assess impact to the global standardized process. Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in overseeing vendors responsible for case processing. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Strong experience of USFDA/EMA/MHRA regulations Strong understanding of reporting rule configuration in the Safety database Good knowledge of MS Office Strong experience with RCA, and implementation of CAPA Experience with PSMF is preferred. Strong experience in ICSR quality review and submissions Strong GVP module VI experience required. Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, MHRA, other health authorities, and ICH. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s Degree in Pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 5 years’ experience in Global PV/Clinical environment. Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers: We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less