Bengaluru, Karnataka
INR Not disclosed
On-site
Full Time
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 : Senior Software Engineer Location : Bangalore, Karnataka ESSENTIAL DUTIES AND RESPONSIBILITIES Design, develop, test, debug, document software, and create /enhance existing components to ensure that software meets business needs Conduct design and code reviews to ensure code developed meets coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines Deploy and maintain enterprise level Applications/Systems Collaborate with other team members, business stakeholders and product owners, both inside and outside the team Demonstrate application features and fixes with product management and users Mentor junior team members on procedures and technical standards Troubleshoot and support deployed systems Attend and participate in applicable company-sponsored training Maintain a strong understanding of software development trends and technology Maintain a strong understanding of the regulatory requirements applicable to software development in clinical trials EDUCATION AND EXPERIENCE REQUIRED: Bachelor’s degree in computer science, strongly preferred Minimum of 5+ years’ experience in Angular with a WebAPI Backend Experience with Microsoft SQL Server or SQL Azure. Experience with an Agile development process Experience with .net Framework and C# Strong interpersonal and communication skills, both verbal and written. Experience identifying and troubleshooting software problems. Strong organization skills and ability to prioritize and meet deadlines Experience conducting process re-engineering and improving costs/quality. 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: Full Time, Permanent 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.
Bengaluru, Karnataka
None Not disclosed
On-site
Full Time
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.
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