Pharmacovigilance Periodic Reporting Oversight Specialist

Job Description

Job title: Pharmacovigilance Periodic Reporting 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: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide. 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 four 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 to bring health in your hands at www.opella.com. Main Responsibilities The PRM Oversight Team are the specialists on the regulatory requirements (CH GVP, ICH, CFR etc.) and process owners for the authoring Global periodic safety reports (PSRs) coordinated by Opella Global Pharmacovigilance (Opella PV).The PRM Oversight Team is the Opella GPV representative in inspections and audits responsible for explaining PSR authoring processes owned by the PRE Team.The PRM Oversight is responsible for providing responses to Health Authority Assessment reports regarding PSR content in collaboration with the Global Safety Officer (GSO), Global Safety Sciences and Qualified Person for Pharmacovigilance (QPPV) when applicable.Through content authoring and project management activities, the PRM Oversight ensures Global continuity of the safety messaging within PSRs across applicable regulatory submission documents (RMP, DSUR, RSI) to support final approval and signature by the GSO/QPPV.The PRM Oversight team assures PSR submission compliance to global regulatory authorities by fostering productive and supportive relationships with internal participants (GSO, QPPV, Risk Management Office, Global Safety Sciences, System Support Unit) and PSR contributors external to Opella GPV (Global Business Units, Medical functions, Global Regulatory Affairs, Biostatistics and Programming, Clinical Science Operations).The PRM Oversight drives continuous improvement for periodic reporting processes and quality documents.The PRM Oversight team oversees vendors participating in periodic reporting activities, provides clear guidance on process expectations and productive feedback to ensure adherence to quality document requirements.The PRM Oversight is the centralized Opella PV expert on the regulatory framework for Global PSRs.Provides Global PSR format training and support to contributors.Participates in inspections and audits to communicate PSR processes and expectations as defined in quality documents.The PRM Oversight team implements process and quality document changes when regulatory requirements change, or process improvements are identified.The PRM Oversight authors and coordinates the pharmacovigilance content, including signal detection analyses, for Global PSRs with respect to the cumulative product experience.The PRM Oversight is the expert in systematically assessing relevant product content for inclusion in PSRs from available regulatory and product monitoring documentation.Leads and manages the cross-functional coordination of PSRs and Global PV contribution to PSRs to ensure regulatory submission compliance.Leads the authoring of Global PSRs according to an existing outsourcing strategy.The PRM Oversight is expected to foster productive relationships with cross-functional teams that appropriately represent the PRE team as a whole.Accountable for complying to PRM Oversight timelines, accurate tracking of contributions from contributors and communicating report quality expectations.Responsible for management escalation regarding non-compliance to PSRs timelines, quality expectations, and proceduresAccountable for the maintenance of the appropriate documentation utilized during Global PSR authoring.Participate in Health Authority assessment report responses, inspections, and internal and partner audits regarding the Global PSR processes.Responsible for responding to health authority and partner questions regarding the Global PSR content and processes.Responsible for onboarding, training, and supporting outsourcing vendors to ensure compliance to internal and regulatory process and quality requirements.Provide ongoing productive support and feedback to the vendor to ensure adherence to Opella policies and quality expectationsRequired to track and report recurrent vendor quality issues to management.Responsible for participating in or managing vendor meetings.Provide quality and compliance oversight of vendor activities for Opella Periodic Reports (PBRER/DSUR/SASR/etc.) and continuous improvement of processes:Oversight for PSR-related activities performed by vendorData collection of PBRER KPI’s and documentation of these in Quality trackerQuality findings from QC checklists uploaded in Veeva vault are checked and entered in Quality trackerTimeline guides for PBRER checked and delays (if any, along with the reason for delay) are documented in Quality trackerProvide assessment of critical findings in the Quality trackerManage and support quality and compliance trending/metrics/KPIs/ Scorecard(s) of periodic reports (i.e. HA, PBRER, DSUR, SDEA)Kick Off meeting management and conductContinuous Improvement of PSR processesNew QDs & training plan/documentation for Opella PV Periodic Reports team – maintain quality documents, updated with the new regulations and Opella processes.Organizational ReadinessAccountable for complying to timeline expectations and for the accurate and reliable tracking of quality and compliance metrics for Global PSRsSupport/provide the root cause analyses associated with quality and compliance deviationsManage and provide support for Local PBRER/Business partner requestsParticipate and provide contributions for the Periodic Partner Compliance Review Meeting (PPCRM Survey), relating to any deviation matters identified in respective activities involving Opella Business Partners Experience About you Overall 5-6 years of experience Pharmacovigilance Aggregate Safety Reports, Medical Writing, and Periodic safety reportsExperience in PBRER planning and authoringProactive and strong project management experience including multi-tasking of deliverables with competing timelinesFlexibility to adapt to changing priorities and delaysFluency in ICH and GVP guidelines regarding periodic safety report contentKnowledgeable in PSR relevant regulations across major markets including but not limited to EU, US, China, Brazil, Japan, Canada etc.,Comfortable leading cross-functional meetings in EnglishStrong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environmentProficiency in Microsoft applications (Word, Power Point, Excel)Fluent spoken and written EnglishIncumbent 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 skillsAbility to work in cross-functional teamsExcellent oral and written communication skillsStrong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting RequirementsDatabase 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.Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgradesReport Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives.Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.Leadership, Teamwork and Management skillsGood interpersonal skillsExcellent project management skillsStrong decision-making skillsStrong knowledge of worldwide pre and post marketing safety reporting regulations and requirements and ICH Education Healthcare Professional / Life science Graduate or Equivalent with a 5-year minimum experience of Pharmacovigilance Safety Reports relevant experience 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