Pharmacovigilance Specialist

Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:MBBS
Years of Experience:7 to 11 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 cases in the medical review workflow as per SLA, TAT, and KPI. Review and verify adverse event sections, MedDRA coding, labeling, causality, and provide medical assessment comments for ICSRs. Review medical content and quality of cases to ensure accurate coding and consistency between source documents and narrative summaries. Ensure all relevant information is presented in a logical temporal sequence. Follow up on adverse events to obtain additional information and review all correspondence for appropriateness and completeness. Initiate ad-hoc follow-up activities whenever required. Route cases to Distribution and ensure case locking. Continuously update domain and operational knowledge by reviewing updated SOPs and regulatory requirements. Provide feedback to Book-in and Data Entry teams regarding data quality. Route cases back to the applicable workflow if changes are required. Participate in client discussions and provide medical expertise. Confirm and advise on medical assessment queries from Case Processing Associates, Quality Reviewers, and Book-in Associates. Participate in audits and inspections. Be open to cross-training and role transitions based on business requirements. Train and mentor new associates. Autho
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems • May create new solutions, leveraging and, where needed, adapting existing methods and procedures • The person would require understanding of the strategic direction set by senior management as it relates to team goals • Primary upward interaction is with direct supervisor • May interact with peers and/or management levels at a client and/or within Accenture • Guidance would be provided when determining methods and procedures on new assignments • Decisions made by you will often impact the team in which they reside • Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture • Please note that this role may require you to work in rotational shifts