Pharmacovigilance Services Sr Analyst

Accenture; Chennai District; On-site; INR 600,000 - 900,000; Full time

Job summary

Accenture in Chennai, India seeks a Pharmacovigilance Sr Analyst to join the Life Sciences RD vertical. You will be aligned with Pharmacovigilance Drug Safety Surveillance, handling literature monitoring, ICSR processing, and safety signal assessment for global regulatory compliance.

You will create and manage case identification, data entry and MedDRA coding in the safety database as per client guidelines, while ensuring patient safety and regulatory adherence in a dynamic team environment.

Qualifications

• Bachelor's degree in Pharmacy, Physiotherapy, or Nursing.
• Strong literature monitoring and pharmacovigilance knowledge.
• Experience in processing Individual Case Safety Reports (ICSR) from literature sources.
• Understanding of regulatory safety reporting requirements.

Responsibilities

• Analyze and solve increasingly complex problems.
• Day-to-day interactions with peers within Accenture.
• Some interaction with clients and/or Accenture management.
• Receive minimal instruction on daily tasks and moderate guidance on new assignments.
• Role may require rotational shifts.
• You would be an individual contributor and/or oversee a small work effort or team.

Education

Bachelor of Pharmacy

Bachelor of Physiotheraphy

BSc. Nursing

Job description

Skill required:

Pharmacovigilance Services - Pharmacovigilance Drug Safety Surveillance

Designation:

Pharmacovigilance Services Sr Analyst

Qualifications:

Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing

Years of Experience:

3 to 5 years

What would you do

You will be aligned with our Life Sciences RD 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 worlds leading biopharma companies bring their vision to life 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 ICSR's in the safety database as per client guidelines and applicable global regulatory requirements.

What are we looking for

• Strong experience in Literature Monitoring and Surveillance for Pharmacovigilance activities.
• Proficiency in identifying, reviewing, and processing Individual Case Safety Reports (ICSRs) from global and local literature sources.
• Experience in conducting Benefit-Risk Assessments and evaluating safety information from published literature.
• Knowledge of literature databases, literature screening methodologies, and regulatory requirements related to safety reporting.
• Ability to assess scientific publications and identify reportable safety information in accordance with applicable pharmacovigilance guidelines.
• Literature screening/processing

Roles and Responsibilities:

• In this role you are required to do analysis and solving of increasingly complex problems
• Your day to day interactions are with peers within Accenture
• You are likely to have some interaction with clients and/or Accenture management
• You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments
• Decisions that are made by you impact your own work and may impact the work of others
• In this role you would be an individual contributor and/or oversee a small work effort and/or team
• Please note that this role may require you to work in rotational shifts

Qualification

Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing