Associate Quality Assurance require at Indegene

At Indegene, we look to change healthcare for the better. Being an Indegene employee is not just doing a job, but it is about real contribution and outcomes. We are a global team of over 1,200 employees across 14 global locations. Our singular focus is to deliver real outcomes that are measurable, impactful, and sustainable. This has made us a recognized global leader and partner to some of the largest and most respected healthcare organizations.

Post : Associate Quality Assurance

Job Description
• Perform QC of ICSRs (spontaneous, literature and solicited) for completeness, accuracy, medical relevance and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement
• Review if follow-up information is medically significant or relevant and takes necessary actions, check if the narrative to ensure all the information has been captured in a systematic manner as per the client requirement, review to ensure if additional queries are raised by the respective stakeholders for any missing data or clarification and document appropriately in the safety database.
• Communicate the QC observations to the applicable stakeholders and ensure the appropriate RCA/CAPA is obtained from the respective stakeholders for the applicable QC observations
• Adhere to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards, requirements and policies and attend all internal trainings and client trainings and ensure compliance with applicable guidelines.

Candidate Profile
Life science post-graduate with 2 to 3 years of experience in PV, ICSR, QC.

Desired Skills
1. Minimum 2 to 3 years of experience in ICSR and Case processing in pharmaceutical companies in any of the following functions- pharmacovigilance
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.

Additional Information
Experience : 2 to 3 years
Qualification : Life science post-graduate
Location : Bangalore - Manyata Tech Park
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 30th March, 2021