Pharmacovigilance Services Analyst
About the Role
Company Overview
Accenture is one of the leading international consulting firms. Accenture has a presence in over 120 countries across the world. The firm has offered several services related to consulting, technology, operations, and digital transformations.
Accenture works with the pharmaceutical and biotechnology industry. They work on pharmacovigilance and drug safety solutions for these companies. They provide case management, safety data management, regulatory, and technology solutions. This is aimed at ensuring patient safety.
In addition to this, Accenture is known for developing the careers of its employees. There are numerous training programs and career development programs in place within the firm.
Job Summary
The Pharmacovigilance Services Analyst position entails the provision of support for activities related to drug safety monitoring and aggregate reporting.
The individual selected will prepare and review the safety reports and cases, and will adhere to the global pharmacovigilance guidelines. The individual will carry out tasks related to:
Periodic safety report preparation
Health authority submissions
Safety data analysis
This should be done within the set SOPs and client’s guidelines.
Key Responsibilities
Prepare and review aggregate safety reports such as PSUR, PBRER, DSUR, and PADER as per project requirements and regulations.
Work on addendum statements, clinical overview addendum, US IND reports, cumulative reviews, and local safety reports.
Manage health authority queries and prepare assessment reports as per requirements.
Scheduling and management of reports. Authoring, peer reviewing, and publishing of reports.
Manage Request for Information (RFI) process. Preparation of inputs for report preparation.
Submit case closure requests and submit line listings and tabulations of the same.
Arrange and conduct safety strategy meetings for discussion of safety topics. Prepare and distribute meeting minutes.
Conduct case identification, data entry, MedDRA coding, and case processing of ICSR's.
Ensure safety case submissions as per regulations.
Adhere to SOPs, client guidelines and Global Pharmacovigilance Standards.
Qualification and Skill Requirement
Education: B.Pharm/ M.Pharm/ B.Sc Nursing
Experience: 1 to 3 years in pharmacovigilance or drug safety
Pharmacovigilance and drug safety monitoring expertise is a must-have.
Should have previous experience in drafting aggregate reports such as PSUR, DSUR, and PBRER.
Critical to have awareness of ICSR case management and MedDRA terminology.
Excellent analytical and problem-solving skills are crucial when dealing with safety data.
Effective written and oral communication skills are a must.
Team player skills with a moderate level of supervision are needed.
Ability to work in shifts when necessary.
Salary and Benefits
Accenture provides a lucrative salary package depending on one’s experience level and the level of the job position. The pay scale of this position varies between ₹6-8 LPA in India.
Health insurance, paid vacation, and wellness facilities are some of the benefits enjoyed by employees at Accenture.
In order to improve the competencies of employees in pharmacovigilance and regulatory affairs, learning and development programs are provided to the employees.
Employee assistance programs, career advancement programs, and performance incentives are other benefits.
Role Importance and Career Growth
This job is really crucial to guarantee the safety of patients by monitoring and reporting the risks of drugs. This will also help with the regulations to make sure that drugs are used safely.
The main opportunities for exposure in this position include aggregate reporting, safety surveillance, and regulatory submission. This may lead to senior positions like:
Senior Pharmacovigilance Analyst
Drug Safety Specialist, or
Aggregate Report Lead
How To Apply
Interested candidates can apply by:
Create your account on Jobslly.
Search for the job Pharmacovigilance Services Analyst/ Accenture.
Upload an updated resume.
Upload any relevant certifications.
Submit the completed application.
Ensure your resume highlights relevant pharmacovigilance experience, case processing expertise, and knowledge of regulatory guidelines.
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.