Senior Pharmacovigilance Services Analyst

Pharmacovigilance Services Sr Analyst

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Sr Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:5 to 8 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Pharmacovigilance Services involve the detection, assessment, and prevention of adverse effects related to pharmaceutical products. These services ensure the safety and efficacy of medications by monitoring and analyzing data from clinical trials, healthcare providers, and patients. The goal is to identify potential risks and take appropriate actions to protect patient health. They also help pharmaceutical companies comply with regulatory requirements. Effective pharmacovigilance services are essential for maintaining public trust in medications. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? Prioritize FDE QC for ICSRs based on client guidelines, regulatory due dates, TAT, SLA, and KPIs. Evaluate and perform QC of ICSRs to ensure accurate and consistent data entry and processing from source documents, focusing on timelines and quality. Ensure accurate and consistent coding of medical history, drugs, and adverse event terms. Assess adverse event reports in consultation with Medical Reviewers when required. Evaluate adverse events for seriousness, causality, expectedness, and applicable labeling. Confirm accuracy of terminology, coding, and manually recoded errors or inconsistencies. Ensure discrepancies identified during QC are corrected or routed back to the appropriate workflow. Act as an SME by coordinating CAPA sessions and refresher training for team members. Work closely with team leads, tower leads, clients, and stakeholders to resolve quality issues. Perform correction of case errors as required. Review and complete case suppression/nullification activities when appropriate. Alert Medical Reviewers to potential safety issues. Perform quality checks of fatal and serious cases. Maintain quality metrics and communicate findings to processing associates to improve quality. Mentor and train new hires and other assoc
Roles and Responsibilities: •In this role you are required to do analysis and solving of increasingly complex problems • Your day to day interactions are with peers within Accenture • You are likely to have some interaction with clients and/or Accenture management • You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments • Decisions that are made by you impact your own work and may impact the work of others • In this role you would be an individual contributor and/or oversee a small work effort and/or team • Please note that this role may require you to work in rotational shifts