Pharmacovigilance Case Submission Oversight Specialist

Job Description

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