Senior Drug Safety Associate
Crius Life Sciences · Noida · onsite · Posted 24d ago
Undisclosed2–4 yrsfulltimeSourced from
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About this role
Job Overview: Senior Associate - Clinical Safety and Pharmacovigilance
Key Responsibilities-
- Support in the area of drug safety and pharmacovigilance activities as requested by the management.
- Record and review adverse drug reactions in the safety database or other database, as relevant, for post marketing and clinical trial reports in accordance with the applicable regulatory standards and Soterius clients procedures, with high accuracy and quality.
- Provide support in the development and deployment of the assigned technology solutions, including administrative support, implementation, validation, upgrades, bug fixes, change requests and support throughout the product lifecycle.
- Communicate with required stakeholders, as necessary.
- Carry out the necessary administrative duties required for the job.
- Ensure effective functioning of assigned projects (including but not limited to ICSR case processing and compliance with client agreements and applicable regulations and guidelines.
- Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
- Management of quality, compliance, and documentation across assigned projects.
- Alert the functional head /designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
- Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
- Train and mentor personnel, as needed.
- Identify new training and development requirements relevant to the function.
- Respond to /represent department /function during audits and inspections, as required.
- Author and review SOPs and other documents relevant to department and function, as required.
- Other responsibilities as assigned by the Management.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Senior Drug Safety AssociatePersonnel ManagementpharmacovigilanceDrug safetyCase ProcessingmanagementAdministrationcomplianceTraining And DevelopmentFunctional Head
About Crius Life Sciences
Crius Life Sciences
201
employees
₹4.1L PA avg
Avg at Crius Life Sciences
About
Soterius is a healthcare and life sciences services company specializing in pharmacovigilance, regulatory affairs, and clinical research support. It partners with pharmaceutical and biotech firms to ensure drug safety, compliance, and efficient development processes. By combining scientific expertise with technology-driven solutions, Soterius helps organizations meet global regulatory standards and deliver safe, effective therapies to patients.
Industries
Manufacturing
Employee ratings
10 reviews
4.3/ 5
Culture
3.5
Career growth
3.0
Work-life
3.9
Employees rate it well for
Overall Company43Work-Life Balance42
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