Pharmacovigilance Services Sr Analyst

Skill required: Pharmacovigilance Operations - Pharmacovigilance Drug Safety Surveillance


Designation: Pharmacovigilance Services Sr Analyst


Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing


Years of Experience:3 to 8 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.


What are we looking for

Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project.

Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports.

Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs).

Send the case closure request and request for Line Listings/Summary Tabulations, as applicable.

Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees.

Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project.


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,Master of Pharmacy,BSc. Nursing