Pharmacovigilance Case MR Oversight Specialist

Job Description

Job title : Pharmacovigilance Case MR 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 Case Medical Review (MR) Oversight specialist is to perform the medical and regulatory evaluation of all ICSRs. Oversee the Medical Review of ICSRs as per predefined activity and job-role in PV safety database (DB), with special focus on case medical accuracy and documentation. Maintain overall accountability for the timeliness and quality of medical Case Management activities outsourced to service providers. Be the product medical expert from Medical Review Standpoint for all High priority Products and provide training & guidance to MR teams Lead or participate in cross-functional projects or initiatives within global PV collaborates with the Global Safety Officer (GSO) in the review of clinical trial and post-marketing program documentation and on labeling activities. Establish strong collaboration with cross-functional groups within and outside the company (i.e. Business Partners, CRO). Provide or receive training on Customer-specific processes, systems, or products. Perform daily quality review for ICSRs to allow analysis of data entry/ quality. Reconcile SAEs between the Clinical and Safety DBs to meet joint accountabilities and enable locking of Clinical DB. Provide support for the preparation of response to ad hoc HA queries, provide input into responses to inquiries from health care professionals on safety issues. Assist in study configurations of clinicals trials in the safety database Responsible for performing oversight of non-serious line listing as applicable. Creates and maintains relevant SOPs, job aids for medical review activity. Other PV tasks as required Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Minimum 4 years of pharmaceutical industry experience with a focus on pharmacovigilance Strong Experience in medical review of ICSRs Experience in labelling and causality assessments is must. Experience in overseeing vendors responsible for case processing. Experience with SDEA agreements Experience review in signal activities, RMP, PBRERS, and PADERS etc. Strong experience review of non-serious line listings. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Strong experience in ICSR quality review and submissions 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, ICH, and other health authorities. 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) Education MD (Pharmacology) degree with 2 years' experience required / or MBBS/Pharm D equivalent Academic qualification is desirable with 4 years’ experience in Global PV/Clinical environments. 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