Pharmacovigilance Specialist
Pharmacovigilance Specialist
Accenture
Job description
Curious about drug safety and medical review? Check out the Pharmacovigilance Specialist job in Accenture at Chennai.
Company Description
Accenture is a global professional services company with capabilities in digital, cloud, and security. It provides strategy and consulting, technology, and operations services across more than 40 industries. Its teams combine experience and specialised skills to help clients in over 120 countries create value through technology and human ingenuity daily.
Job Summary
Pharmacovigilance Specialist will review Individual Case Safety Reports (ICSRs) for seriousness, causality, adverse-event selection, MedDRA coding, and labelling. The role checks source documents and narratives, updates global safety databases, writes causality comments, validates data through E2B checks, manages follow-up information, resolves medical-review queries, and supports client discussions, team training, and regulatory timelines under client SOPs across assigned safety projects.
Key Responsibilities
1. Individual Case Safety Reports (ICSRs) should be prioritized according to client criteria, regulatory due dates, turnaround times (TAT), service level agreements (SLAs) and key performance indicators (KPIs).
2. Selection of adverse events for audit, MedDRA coding, labelling and causality.
3. Make company causality remarks in line with client SOPs.
4. Source document review and case narratives for medical accuracy, data consistency checks, updating pertinent fields in the Global Safety Database, E2B validation checks.
5. Respond to medical assessment queries from case processing associates, literature reviewers, quality reviewers and triage associates.
6. Identify missing information, establish follow-up requirements and consult global safety physicians when appropriate.
7. Conduct training for internal & cross functional team members, participate in client case discussion, update operational knowledge with changed SOPs and address queries from internal teams, clients, licensing partners and regulatory bodies
Educational Qualification
Bachelor's degree in any Life Science stream but MBBS is preferred.
Skills Required
1. Knowledge of pharmacovigilance operations, drug safety surveillance and adverse-event reporting.
2. Ability to evaluate adverse-event seriousness, cause, labelling and medical accuracy.
3. Knowledge of global safety databases, MedDRA coding, WHO-Drug nomenclature and E2B validation.
4. Ability to draft medical narratives, company causality remarks and precise safety documentation.
5. Good English communication, analytical thinking, problem solving, training and coordination with cross-functional teams
Salary Structure
The average salary of a Pharmacovigilance Specialist is in the range of ₹25-26 Lakhs per year.
Career Development
This role as a Pharmacovigilance Specialist can provide knowledge in ICSR medical review, adverse event assessment, MedDRA coding, safety databases and compliance. You could develop into senior medical review, pharmacovigilance quality or management of drug-safety operations by taking on challenging issues, supporting clients at meetings and training colleagues.
How to Apply
Open our job portal. Search for Pharmacovigilance Specialist listing.
Review the full job information and check the eligibility conditions.
Fill out the application form.
Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.