Pharmacovigilance Job at Accenture
The Accenture pharmacovigilance job is for a Pharmacovigilance Services Specialist with 7 to 11 years of experience in Pharmacovigilance and Drug Safety Surveillance.
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, Accenture offers 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. Accenture’s 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Accenture embraces the power of change to create value and shared success for clients, people, shareholders, partners and communities. Candidates interested in the Accenture pharmacovigilance job should review the official notification before applying.
Accenture Pharmacovigilance Job Details:
- Company: Accenture
- Skill required: Pharmacovigilance Operations – Pharmacovigilance & Drug Safety Surveillance
- Designation: Pharmacovigilance Services Specialist
- Years of Experience: 7 to 11 years
Job Description:
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
Key Responsibilities:
- Prioritize medical review for Individual Case Safety Reports (ICSRs) in accordance with Client Guidelines, regulatory due dates, turnaround time (TAT), service-level agreements (SLAs), and key performance indicators (KPIs).
- Verify and confirm the selection of adverse events, appropriate MedDRA coding, seriousness, labeling and causality of adverse events, and provide a company causality comment as per the client SOP.
- Review the source documents and narrative to ensure that the medical information pertaining to the case is accurate and entered into the Global Safety Database.
- Write the company causality comment and route the case to the 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.
- In this drug safety specialist role, actively participate in case discussions with the client and provide valuable input 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 or 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, and regulatory authorities.
- ICSRs are evaluated accurately and reviewed within the required timeframes to meet regulatory requirements.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
Eligibility Criteria:
- MBBS (Medical degree)
- Years of Experience: 7 to 11 years
Required Skills for the Accenture Pharmacovigilance Job :
- Primary skill – Pharmacovigilance & Drug Safety Surveillance – P1
- Secondary skill – Medical Review – P1
- 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).
- Ability to learn quickly and contribute to process improvement initiatives in consultation with management.
- Consistent demonstration of company values or behaviors.