Should be comfortable to work from Bangalore Office
Position description:
- Basic competence with medical and therapeutic terminology.
- Ability to work independently but guided by documented procedures, with appropriate support.
- Understanding of patient safety regulatory obligations.
- Should be familiar with regulatory & pharmacovigilance guidelines.
- Should be familiar with pharmacovigilance terminology.
- Excellent attention to detail.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Computer literate. Relevant product and industry knowledge.
Primary Responsibilities
- As a quality check reviewer, you will be responsible for reviewing safety database entries to ensure data completeness, accuracy, and compliance with quality standards.
- Hands-on experience with comparable pharmacovigilance safety databases.
- Ensure adherence to internal and external timelines for adverse event management, product complaint processing, and regulatory case submissions.
- Provide constructive quality feedback to team members and monitor, track, and maintain quality performance metrics.
- Collaborate with cross-functional teams to support continuous quality improvement and ensure compliance with pharmacovigilance processes.
Additional Responsibilities
- Strong motivational skills and abilities, promoting a team-based approach.
- Strong interpersonal and communication skills, both verbal and written.
- Strong organizational and leadership skills Goal-oriented Ability to maintain qualified and positive attitude.
📌 Drug Safety Associate (Bengaluru)
🏢 Qinecsa Solutions
📍 Bengaluru
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