Skill required

Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation

Pharmacovigilance Services Specialist

Qualifications

Any Graduation

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

What would you do?

• Responsible for medical review and assessment of seriousness, causality and labeling of adverse events within agreed timeframes and to a high standard of accuracy, in compliance with Client standard operating procedures and global regulatory requirements. What are we looking for?
• Primary skill - Pharmacovigilance & Drug Safety Surveillance
• Secondary skill - Medical Review
• MBBS (Medical degree)
• Technology skills: experience with MS office, knowledge of safety database
• Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred.
• Good medical writing skills
• Good Communication Skills
• Strong English Language proficiency (Reading, Writing, Listening and Speaking). Roles and Responsibilities:
• Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).
• Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.
• Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database.
• Write company causality comment and route the case to applicable workflow as per Client SOPs
• Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs
• Lead the training of internal and cross-functional team members.
• Actively involved in case discussion with client and provide the valuable inputs to the team.
• Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates.
• Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs
• Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional,missing information as stated in the relevant Client SOP.
• Consult global safety physician for additional inputs on the case as required by client SOP.
• Create action items in global safety database to ensure case details are sufficient for medical evaluation and route the case back for updating as per Client SOP.
• Perform self-review for changes made to case during medical review and E2B validation check for all cases before routing to next workflow.
• Respond to queries from internal teams, clients, license partners, regulatory authorities in a timely manner