Pharmacovigilance Services Analyst

Skill required: Pharmacovigilance Operations - Pharmacovigilance Drug Safety Surveillance


Designation: Pharmacovigilance Services Analyst


Qualifications:Bachelor of Pharmacy/Master of Pharmacy


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 world

s 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 Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products.
Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.


What are we looking for Work with offshore personnel in forecasting the supply of work. Based on the forecasted supply, work with the offshore management team in resource planning.
Calculate capacity available in each team and take necessary steps to move resources if required.
Oversee production details on daily, monthly and yearly basis and report to the management.
Identify areas of concern and highlight to management.
Discuss production status in management meetings and other forums.
Update offshore, onshore managers and Client personnel on metrics on regular basis.
Oversee tools development to help in efficient and / accurate tracking of metrics.
Ensure the tools are maintained and if required, updated to help in accurate reporting.
Work allocation and prioritization - alerting and tracking until closure to ensure adherence to internal and client timelines for submissions.
Coordinate for monthly meetings, team meetings, etc.
Ensure adherence to output targets and prioritization adherence at desired levels.
Provide technical support and guidance wherever needed.
Supports audits and inspections, develop and implement corrective/preventive action plans.
Work with offshore personnel in forecasting the supply of work. Based on the forecasted supply, work with the offshore management team in resource planning.
Calculate capacity available in each team and take necessary steps to move resources if required.
Oversee production details on daily, monthly and yearly basis and report to the management.
Identify areas of concern and highlight to management.
Discuss production status in management meetings and other forums.
Update offshore, onshore managers and Client personnel on metrics on regular basis.
Oversee tools development to help in efficient and / accurate tracking of metrics.
Ensure the tools are maintained and if required, updated to help in accurate reporting.
Work allocation and prioritization - alerting and tracking until closure to ensure adherence to internal and client timelines for submissions.
Coordinate for monthly meetings, team meetings, etc.
Ensure adherence to output targets and prioritization adherence at desired levels.
Provide technical support and guidance wherever needed.
Supports audits and inspections, develop and implement corrective/preventive action plans.


Roles and Responsibilities:

In this role you are required to do analysis and solving of lower-complexity problems

Your day to day interaction is with peers within Accenture before updating supervisors

In this role you may have limited exposure with clients and/or Accenture management

You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments

The decisions you make impact your own work and may impact the work of others

You will be an individual contributor as a part of a team, with a focused scope of work

Please note that this role may require you to work in rotational shifts


Qualification Bachelor of Pharmacy,Master of Pharmacy