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Pharmacovigilance Services Associate

Accenture -
Bengaluru, Karnataka

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Job details

Full-time
12 days ago

Qualifications

B.Pharma
Master's degree
Bachelor's degree
M.Pharma
Data entry
Pharmacy

Full job description

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Associate
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:1 to 3 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 worldâ€™s leading biopharma companies bring their vision to life â€“ 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 ICSR processing activities according to project guidelines, regulatory due dates, TAT, SLA, and KPIs. Assess designated email boxes, identify valid and invalid cases, and determine eligibility for databasing as per client procedures. Perform duplicate checks and complete case booking for valid cases. Inform senders and document invalid cases according to client procedures. Process and evaluate Individual Case Safety Reports (ICSRs). Perform data entry and case processing from source documents while meeting quality and timeline requirements. Ensure accurate and consistent coding of medical history, drugs, and adverse event terms. Assess adverse events for seriousness, causality, and expectedness as per applicable labeling, consulting Medical Reviewers when needed. Generate and update case narratives according to client procedures. Update company comments and causality assessments as required. Alert Medical Reviewers regarding potential safety issues and support safety profile monitoring. Determine whether additional information or follow-up is required and initiate follow-up activities. Perform validation and consistency checks, complete self-QC, and make corrections when necessary. Archive communications related to case
Roles and Responsibilities: •In this role you are required to solve routine problems, largely through precedent and referral to general guidelines • Your expected interactions are within your own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts

Bachelor of Pharmacy,Master of Pharmacy

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Pharmacovigilance Services Associate

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