Medical Reviewer - Aggregate Report

Medical Reviewer-Drug Safety

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title : Medical Reviewer

Location : Mysore-Hybrid

Function : Drug Safety Services

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversee overall Pharmacovigilance (PV) and risk management activities.


• Review all appropriate data for product specific reports.


• Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical

assessments/benefit risk assessments for safety reports.

• Provide medical oversight white creating draft reports based on the approved SOP/WI process.


• Coordinate internal review process and finalize draft reports from medical point of view.


• Assist medical writer in addressing all comments from client and finalize.


• Should review the finalized report even if participated in assisting medical writer.


• Provide expert guidance in PV and Aggregate reporting areas.


• Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team.


• Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR.


• Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports.


• Prepare and review responses to adhoc regulatory queries.


• Appropriate scientific interpretation of relevant information for inclusion into drug safety documents,

prepare and write analytical aggregate reports and other drug safety medical documents.

• Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and

regulatory requirements.

• Planning, organizing, and managing daily work to meet service level timelines and deliverables.

EDUCATION AND EXPERIENCE REQUIRED:

• 
  1-3 years experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable.
  


• 
  Medical Degree (MBBS or higher) from recognized medical school.
  

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Permanent, Full Time

COMMITMENTS:

• 
  Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.
  


• 
  Willing to work in shifts as and when needed.
  
  
  
  
  

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.