9 Vigibase Jobs

Job title: Global Pharmacovigilance Workflow & Oversight Manager 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 Responsible for maintaining case workload in CHAMPS (PV Database (DB)/LSMV) and ensuring the case timelines are within CHAMPS are met. Ensure to a maintain healthy Work in Progress (WIP) case load for Opella. Responsible for maintaining business architecture diagram (all modules in LifeSphere). Responsible for maintaining configurations for LSR tool. Maintain LSMV (CHAMPS) user manual with current SOPs/regulations and case processing conventions. Responsible for trending analysis and alert the case management head for any abnormal increase/decrease in case volumes Responsible for monitoring Capacity utilization of the resources. This role will regularly engage with multiple vendors in different roles and capabilities related to Case Management (CM). This role works cross functionally with internal Opella departments and external resources on ICSR and safety DB related matters. This role will lead and define optimal business models to support business goals and ensure the operational model meets defined strategic key performance indicators (KPIs) crucial to business success for case processing vendor. Ensure optimized process are deployed for ICSR receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution, and submission in compliance with SOPs/regulations. Provide ongoing oversight to ensure a consistent and compliant approach to understanding Opella PV needs and focus on continuous improvement to identify efficiencies. Maintains operation reports from LifeSphere Reporting & Analytics (LSRA)/ LifeSphere Multivigilance (LSMV) and ensures the implementation of effective CAPA plans for identified deviations in CM activities. Support QC lead and work closely with SMEs and Quality Assurance (QA) to improve and exceed quality standards, to identify process improvements and to ensure CM resources have necessary training and skills. Responsible to ensure training slides and attendance sheets for all PV trainings. Assists in CHC case migrations for divestments/ acquisitions and support monitoring quality & timeliness and complete documentation audit trail of DM. Participates in business continuity arrangements and assists with the authoring and implementation of PV Operations business continuity plan (BCP) processes. Collaborates with CHC PV ops leads, CSH and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities. Participate in the development and continuous improvement of processes, workflow, and supporting documents. Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc. Experience in case processing activities. Experience in team management 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 Good knowledge of MS Office 6-8 years of pharmaceutical industry experience with a focus on pharmacovigilance with min 2 years in managing team 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. Time Management: Ability to manage multiple projects and deadlines effectively, ensuring that safety reports and data analysis are delivered on time. 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. Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Technical Skills Understanding of Adverse Event Reporting: Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. 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). Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders. Education Bachelor’s degree in pharmacy / Life Sciences / equivalent Academic qualification is desirable with 6-8 years of experience and min. 6 years in Global PV case processing activities 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

Main Responsibilities Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team Work with Business Users to understand the Configuration changes and document them Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users Support Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis Analyze the impact of changes to the system not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System Implement relevant action items to mitigate any potential issues arising based on the Impact Analysis Responsible for PV System Configurations of PV database- Company Products, Clinical & Post marketed Studies Business user Roles & Data Privacy Code Lists, Libraries, MedDRA, WHO Distribution Rules Accounts & HA Destinations E2B Profiles SDEA profiles & gateway Manage E2B gateway with Health authorities & Business Partners Implement Data Migration & Ingestion requests Actively participate and contribute to the growing needs of Drug Safety PV Regulations Support digital vendor teams in Configuration Changes needs, Testing & Deployments Work with Business Users to understand the Configuration change needs and document them Work in an Agile environment Experience About you Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc. Experience in a systems operations support role within safety/pharmacovigilance as configuration analyst, configuration manager Hands-on in Case Processing to support the Business User for troubleshooting and problem solving Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events Hands-on experience in dealing with Local Affiliates and understanding their Regulatory needs Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems Knowledge of validation processes Good knowledge of SQL, PL/SQL and MS Office Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Strong experience in Computer System Validation is required Incumbent should have hands-on 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, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements. 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. Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades Good depth understanding of Quality Risk Management and Quality systems Education Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5 years’ Technical Experience in GxP systems preferably in PV databases Languages : Fluent in English (verbal and written) Show more Show less

Main Responsibilities The is a centralized role that is Responsible for collaborating with Country Safety heads (CSHs), Qualified Person for Pharmacovigilance (QPPV) office, SDEA, PV Case Medical Safety Manager, SSDM team to ensure that appropriate reporting rules (product, study, country) have been configured in the global PV DB. Responsible for overseeing PV labelling documents in Veeva Vault and ensure access to all parties involved. Responsible for providing support on getting labelling automated within PV Safety DB for all CHC products. Responsible for coordinating between countries and SSDM team for configuring distribution/ reporting rules. Responsible to follow QDs/ SOPs relevant to above mentioned activities. Responsible for review of the Weekly Veeva Flash report for newly registered CHC Products and configuration in the global PV database. Responsible for review of the Weekly Veeva Monitoring listing received for registration lifecycle updates for products globally and requesting the updates in global PV database CPD. Responsible for review of Vault RIM product updates and addition of new products for configuration in global PV database CPD. Responsible for maintaining mapping sheets of CHC products and truncated product lists with their respective names Responsible for review of the Regulatory Intelligence updates emails (CHC Global PV contact mailbox) from CSH/Affiliates, release communication to respective stakeholders and track the progress the required updates in global PV database as applicable. Responsible for implementation Annual product review and Annual distribution rules review with the help of CSH for all the countries and CHC products in global PV database as per the established SOPs. Other PV tasks as required. This role is responsible for ensuring product configurations, distribution rules configurations and maintain of CPD. This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the constantly changing PV Regulations and ensuring that we follow them Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. 3-4 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in product configurations, reporting rule configurations. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Good knowledge SDEA agreements Strong experience in product dictionaries and database reporting rule configurations 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). 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 3-4 years’ experience in Global PV database and/or PV case Management Languages : Fluent in English (verbal and written) Show more Show less

Main Responsibilities Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team Work with Business Users to understand the Configuration changes and document the same Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users Analyze the impact of changes to the system included but not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System Responsible for PV System Configurations of PV database- Company Products, Clinical & Post marketed Studies Business user Roles & Data Privacy Code Lists, Libraries, MedDRA, WHO Distribution Rules Accounts & HA Destinations E2B Profiles SDEA profiles & gateway Configure E2B gateway for Health authorities & Business Partners Perform Data Migration & Ingestion requests Support digital vendor teams in Configuration Changes needs, Testing & Deployments Work with Business Users to understand the Configuration change needs and document them Work in an Agile environment This role will be one of the contact points for Business Users in CHC PV organization for all topics related to the Configurations of PV systems and databases, ensuring that the CHC PV needs are met This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the PV Configurations and ensuring that we follow PV Regulations Experience About you Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc. Experience in a systems operations support role within safety/pharmacovigilance as configuration analyst Hands-on in Case Processing to support the Business User for troubleshooting and problem solving Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems Good knowledge of SQL, PL/SQL and MS Office Minimum 4 years of pharmaceutical industry experience with a focus on pharmacovigilance Incumbent should have hands-on 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, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements. 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. Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades Good depth understanding of Quality Risk Management and Quality systems Education Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with minimum 4 years’ experience in GxP systems preferably in PV databases Languages : Fluent in English (verbal and written) Show more Show less

Job title: Pharmacovigilance Case Quality Oversight Expert 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 About the job: The PV Case Quality Oversight Expert is in charge to analyze Quality data related to ICSRs and to contribute to processes improvement related to Case Management (CM) & Medical evaluation. Responsible for ensuring ICSR submission compliance and ICSR quality compliance is achieved by performing oversight activities as applicable ICSR quality analytics and process related activities for case management Analyze in-process quality checks (QC), reporting of results, tracking quality findings, metrics against, defined KPIs and implement actions provided by Global PV case quality lead. Analyze ICSRs quality data of in-line workflow QCs/ off-line QCs (e.g., correction requests). Analyze quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness. Adjudicate findings accuracy. Drive continuous process improvement for CM by partnering with all entities, Country Safety Leads (CSL), License Partners, and vendors. Responsible to compare various quality metrics and provide comprehensive Quality analysis with action items Oversee Quality CAPA management for CM Investigate associated root causes and proposes CAPAs. Identify ICSRs trends, prepares, or coordinates preparation of ICSRs Quality report. Participate in CAPAs elaboration (e.g., trainings, QDs updates and user manual). Monitor CAPAs implementation and assess CAPAs effectiveness. Participate in vendor quality oversight activities, liaise regularly with vendors, and ensure quality consistency across CM functions. Lead or contribute to the Case quality review meetings for ICSRs where trends are presented, CAPAs proposed or discussed, efficiency assessed. Communicate analysis results to the CM / CSE PV community. Oversee the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports. Create and maintain CAPA records to be provided for inspections/ audits. Review and create SOPs, job aids, etc for case management activities Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Overall 6+ years of experience, with minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in handling Quality events, CAPA, Deviations Experience with QMS. 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, submissions, CAPA, Deviation Management, RCA and trending analysis. Strong experience in effectives checks and trending analysis of the effectiveness check. 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). 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 PV Quality for case management 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

Job title: Pharmacovigilance Case Submission 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. About The Job Main responsibilities: This role is accountable for managing inbound and outbound activities, as well as overseeing follow-up and reconciliation processes. Inbound activities Manages inbound mailboxes. Accountable for ensuring the good quality of the Inbound mailbox management, to identify any deviation and to adapt the process if needed. Manages inbound receipt of global cases from all sources and support country intake. Oversees ICSR intake activities focusing on the operational processes of ICSR receipt, acknowledgement of receipt, archiving of paper ICSR files, follow-up requests, adverse events of special interest (AESI) forms, and non-valid cases. Perform any administrative activity related to the intake and other CM process, as well as to manage the archiving of ICSR when appropriate. Follow-up Activities Oversees the follow-up activities performed by the countries. Accountable for reviewing periodically the follow-up reports extracted from the database (DB), to identify any deviation to the QD, to request CAPAs to the CSL when applicable to aggregate the data and provide the corresponding KPIs to the relevant Opella Global PV Operations leads. Responsible for sending the follow up letters when appropriate. Reconciliation Activities Responsible for managing the monthly case reconciliation with point of intake (Clinical Services Unit [CSU], business partners, etc.). Responsible for managing the outbound reconciliations with partners including but not limited to periodic reconciliations for digital and social media program vendors at a frequency as agreed upon in the agreements. Outbound/Submission Activities Submit/ track all expedited ICSRs to the European Medicines Agency (EMA), FDA and ROW and to electronically distributed the cases to the partners. Oversee all outbound transfer of cases from safety DB in compliance with requirements. Has oversight of the reporting rules configuration for compounds, marketed drugs, CHC products and devices to ensure proper distribution/ submission to HAs, affiliate countries, license partners/ collaboration partners. Has regulatory reporting expertise in all major regions. Has oversight of ICSR submission related activities in all regions, ensuring safety DB is operational, prompt escalation of system outage affecting ICSR distribution/submission process. Contributes to the investigations of late case registration. Is accountable for ensuring the accurate completion of the E2B submission activities to the EMA and FDA by overseeing the receipt of the Message Delivery Notifications (MDN) and the acknowledgments (ACK). Responsible for the tracking of the submission dates for Investigational New Drug (IND) in the US in the Global PV DB and to ensure that no data is missing. Responsible to oversee the distribution of expedited cases by mail to the business partners. Accountable for the accurate management of the Suspected Unexpected Serious Adverse Reaction (SUSAR) distribution to the clinical entities. Other PV tasks as required. Experience About you: Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. 4+ 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 Good knowledge of MS Office Strong experience in inbound and outbound ICSR quality review and submissions Experience performing reconciliations. Knowledgeable about SDEA agreements 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). 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 4+ years’ experience in Global PV case management activities 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

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

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

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