We are hiring for Medical Safety Physicians with minimum 1 year of experience in Drug safety. Work Location : Remote Below is the detailed Job description of the role: Primary Responsibilities As a medical reviewer Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion Perform triage of cases and determine seriousness and relatedness across products as assigned Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas Escalate complex case issues on client product(s) to the medical review team of the client as appropriate Conduct assessment of litigation cases across products as assigned Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate Acquire and maintain knowledge of applicable Global Health Authority regulations Perform any other drug safety related activities as assigned Specialized knowledge and skills : Experience with relevant safety databases and related software applications Proven experience in customer handling and relationship. Proven ability to perform task management. Proven people management skills. Must have good presentation skills and the ability to give presentations. Knowledge of the Life Sciences Industry and life cycle of drug. Relevant product and industry knowledge Secondary Responsibilities strong competence with medical and therapeutic terminology Understanding of Patient Safety regulatory obligation Good attention to detail Ability to deliver within established timelines Fluency in Spoken and written English and excellent comprehension Qualifications Education: MBBS / MD Experience: 0-2 years of experience in pharmacovigilance with minimum 2 years of clinical experience.

Primary Responsibilities QA test engineer experienced with functional and system testing preferably worked on life sciences products on validated test environment. 8+ years overall experience and at least 4 yrs. experience in validation testing in regulatory environment. Review requirements, specifications and create manual test cases for OQ testing. Perform manual test executions for OQ testing in validated test environment. Capture test results and test evidence as per the expected result. Able to log the defects/deviations, analyze the issues and track them until they resolve. Working knowledge with functional, regression, system and DB testing. Proficient in SQL and able to create and execute medium to complex SQL queries. Proficient in SDLC agile or V-model methods. Ability to follow the release timelines and deliver the assigned task within the release. Document test results and review with the project team and clients as needed. Knowledge with risk-based functional and regression testing by analyzing the requirements and changes. Familiar with FDA 21 CFR part 11 and EU compliance guidelines and knowledge of GXP systems. Proactive with the changes in the applications and update the test suite as needed. Knowledge of ETL, data migration testing. Secondary Responsibilities Knowledge of automation regression test scripting and execution. Knowledge in web services testing tools like postman etc., Worked on Highly configured products, applications, and reports. Knowledge of SOPs, templates and WIS documents. Qualifications Education: BE/BTech or any 4 yrs. degree in any discipline. Experience: Life science software products testing with data analysis skills. Experience with pharmacovigilance data management is an added advantage. Additional Skills Strong motivational skills and abilities, promoting a team-based approach. Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills and Goal-oriented. Ability to maintain professional and positive attitude. Show more Show less

Purpose The Automation Test Engineer will work within the Quality Assurance Team to design and implement automation coverage for MyMeds&Me products. The role works closely with the Quality Assurance Team, Test Lead and SDET throughout the development life cycle to ensure that projects delivered by the company are of the highest quality and meet internal and external testing standards. The Senior and Lead roles will provide design and leadership of architecture and team management. Key Areas of Responsibility While MyMeds&Me may, from time to time, request additional activities or deliverables, the key areas of responsibility for this role are described below: {Role} Outcomes & Responsibilities Deliverables & Metrics Manages the creation of a test automation strategy and ensure increasing testing coverage Gather requirements from end-users to develop the best automation solutions. Test design techniques and of performing and applying risk analysis to identify test types and test coverage. Collaborate with other teams to understand how automation can improve workflow.r Perform Risk-based testing, Exploratory and awareness of different types of Test Techniques. Identify the market trends and other forms of testing and tools to be incorporated into the existing framework Understand Non-Functional testing (Performance and Security) needs for the application and coordinate with relevant teams is an advantage. Agile working environments, pairing and working within a collaborative team. Manage teams of test automation engineers setting priorities Qualification In order to perform this role, individuals must have the following qualifications, competencies and personal qualities: Educated to degree level in Computer Science a relevant discipline 2-3 years of experience in development and execution of test suites and test plans 5+ years’ experience in design, strategy and architecture of test automation frameworks and leading teams Demonstrated experience of testing approaches and test tools, methodical and structured approach Demonstrated practical experience with an Agile development methodology - experience in Agile working environments, pairing and working within a collaborative team. Experience writing code with Java, Selenium using Java JavaScript, Ruby, Python, or C# Over 2 years of proven Automation Test, with the ability to work as part of a small team in an agile environment Ability work closely with Developers and Product Owners to ensure features/bug fixes are 'shippable' by sprint end International Software Testing Qualifications Board (ISTQB) Test Manager Advanced Level Certification Team Leadership experience within a testing team, Working with CI environments. Understanding of web technologies (such as .NET, HTML etc.) Web application and database knowledge Experience of manually testing and snagging websites/web-software Contribute to Sprint Planning, Sprint Refinement sessions, Sprint review/Retrospectives and Daily Stand-up meetings Good verbal and written communication, Excellent analytical skills, High technical standards High level of experience in building and improving automated test frameworks. Hand-on experience in Selenium and framework like Page Object Model Experience in Git and GitHub Knowledge/Experience in AWS test automation Experience in using test design techniques and of performing and applying risk analysis to identify test types and test coverage. A curious observant, and intuitive explorer who is capable of the setup, exercise and checking of test scenarios against the system-under-test Collaborates and communicates well Show more Show less

About the Company Qinecsa is a trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions. we take pride in being the leading specialist pharmacovigilance provider, offering unparalleled expertise in PV services, technology, and consulting to cater to the unique needs of small, medium, and large pharmaceutical companies. Job Title: PV Solutions Analyst – RFX & Proposals Location: Bangalore (Office Based / Hybrid) Employment Type: Full-time Experience Level: 2+ Years Job Description : We are seeking a proactive and knowledgeable PV Solutions Analyst to join our growing team. This role is critical in shaping and supporting tailored pharmacovigilance operating models in response to RFXs, proposals, and client solutioning needs. The ideal candidate will serve as a Subject Matter Expert (SME) for PV services, ensuring that proposed solutions are compliant, scalable, cost-effective, and aligned with global regulatory expectations. Key Responsibilities: Design and support end-to-end pharmacovigilance operating models in response to RFXs and client requirements, ensuring alignment with regional and global regulatory standards. Act as a core PV SME in authoring, reviewing, and refining RFX responses and proposals, working closely with cross-functional teams (operations, regulatory, technology, and commercial). Ensure proposed PV solutions are built for scalability, performance, data security, and compliance with industry best practices. Develop effort and cost estimation models based on PV activity scope to support pricing and commercial strategies. Participate in internal proposal reviews, identifying areas for improvement and innovation in solution offerings. Contribute to competitive intelligence efforts, gathering insights on industry trends, pricing models, and client expectations to inform strategic positioning. Qualifications: Education : Bachelor's degree or higher (preferably in Life Sciences, Pharmacy, Medicine, or a related discipline). Experience : Minimum 2 years of relevant experience in pharmacovigilance, drug safety, or related domains, with exposure to RFX or client solutioning processes. Required Skills & Attributes: Solid understanding of pharmacovigilance processes across case processing, safety database management, and regulatory reporting. Working knowledge of PV systems such as Oracle Argus, ArisG, or other safety databases/platforms. Strong analytical skills with the ability to translate operational needs into strategic solutions. Excellent written and verbal communication skills; ability to contribute to formal RFX documentation and client-facing proposals. Highly organized, detail-oriented, and capable of managing multiple priorities under tight timelines. Team-oriented , collaborative, and able to work effectively across global and cross-functional teams. Self-motivated with a proactive and positive approach to problem-solving and innovation. What We Offer: Competitive salary. Opportunity to work with a dynamic and innovative team and world-class clients. Professional development and growth opportunities. A collaborative and inclusive work environment. Equal Opportunity Statement: Qinecsa is an equal opportunity employer. Qinecsa evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic. How to Apply: Interested candidates are invited to submit their resume and cover letter to rubeena.marutla@qinecsa.com Show more Show less

Job Title: Director of Technical Engineering - Pharmacovigilance Signal Detection Solutions Location: Remote Job Type: Full-Time Job Description: We are seeking a Director of Technical Engineering to lead the technical design and development of pharmacovigilance signal detection solutions based on our flagship Qinecsa Vigilance Workbench signal detection platform. The ideal candidate will have a strong background in statistical programming, healthcare related datasets and be an expert in Python, JSON, PL/SQL, and SQL . This role requires deep technical expertise, a strong desire learn about our products, along with excellent leadership skills and a passion for advancing drug safety technologies. This is a combined development and team leadership role where the candidate will be expected to be a hands-on senior developer, as well as coach, lead and manage a small team. Key Responsibilities: Develop robust data pipelines and advanced configuration using python, JSON, SQL to implement out clients signal detection strategies using increased frequency and disproportionality algorithms. Oversee a growing team of technical engineers, providing guidance, mentorship, and support. Collaborate with cross-functional teams to ensure alignment with client business and regulatory requirements. Review and assure the quality work of those in the team, ensuring the accuracy, reliability, and performance of signalling data pipelines and a associated technical documentation. Stay current with industry trends and emerging technologies to drive innovation. Where necessary, support client facing design teams to ensure feasibility and effectiveness of desired solutions, communicating technical concepts and solutions to non-technical stakeholders. Work with project manager and PMO to help plan resources effectively, and support the management of work to required timelines and budgets, and resources. Characteristics: Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Enjoys leading, coaching and nurturing a team Essential Experience and Qualifications: Bachelor's or Master's degree in Computer Science, Software Engineering, Informatics or a related field. Proven track record of leading technical teams and delivering complex projects. Experience in statistical programming and data analysis. Expertise in Python, JSON, PL/SQL, and SQL. Familiarity with cloud-based solutions and big data technologies. Preferred Experience and Qualifications: Experience with signal detection in the context of pharmacovigilance. Knowledge of regulatory requirements and industry standards for drug safety. What We Offer: Opportunity to work with a dynamic and innovative team and world class clients. Professional development and growth opportunities. A collaborative and inclusive work environment.

About the Company Qinecsa is a trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions. we take pride in being the leading specialist pharmacovigilance provider, offering unparalleled expertise in PV services, technology, and consulting to cater to the unique needs of small, medium, and large pharmaceutical companies Location: India Job Type: Full-Time Job Description: We are seeking a Consulting Technology Project Manager to manage client implementation projects for our Pharmacovigilance SaaS solutions. The ideal candidate will be a dynamic client facing services professional with extensive project management experience in the life science technology domain. This is a strategic role requiring deep project management expertise, pharmaceutical domain knowledge, and excellent leadership skills. Key Responsibilities: Lead end-to-end project management of client software implementations, upgrades, and integrations. Develop and manage project plans, including timelines, budgets, and resource demand, and author project initiation documents. Coordinate cross-functional, global teams to ensure successful project delivery. Serve as the primary point of contact for senior client stakeholders, ensuring clear communication and strong relationship management. Ensure the accuracy, reliability, and performance of all project deliverables. Monitor project progress and performance, identifying and mitigating risks and issues as they arise. Facilitate regular project status meetings and provide updates to stakeholders. Actively manage project scope and costs, ensuring any changes are documented and approved through formal change control processes. Develop and maintain comprehensive project documentation, including project initiation documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support continuous improvement of project management processes, tools, and best practices within the organization. Mentor and guide junior project managers and team members, fostering a collaborative and high-performance team environment. Characteristics: Well-organized self-starter with attention to detail. Excellent client facing communication and problem-solving skills. Strong written, communication, and interpersonal skills. A desire to learn about our proprietary products Essential Experience and Qualifications: Bachelor's or Master's degree in Computer Science, Information Technology, Project Management, or a related field. 8+ years of experience in project management, with at least 5 years in a senior or lead role delivering software solutions to pharmaceutical or life sciences clients. Proven experience managing pharmacovigilance, clinical, or regulatory technology projects. Knowledge of pharmacovigilance workflows and regulatory standards (e.g., ICH E2E, GVP Modules, FDA, EMA). Expertise in project management methodologies (e.g., Agile, Scrum, Waterfall). Proficiency in project management tools (e.g., Microsoft Project, Jira, SmartSheet). Preferred Experience and Qualifications: Familiarity with signal detection, case management, and safety databases (e.g., Argus, ARISg). Familiarity with cloud-based solutions and big data technologies. Technical background with experience in software development or IT infrastructure. Knowledge of regulatory requirements and industry standards for technology solutions. Certification in project management (e.g., PMP, PRINCE2). What We Offer: Competitive salary Opportunity to work with a dynamic and innovative team and world-class clients. Professional development and growth opportunities. A collaborative and inclusive work environment. Work from home with limited travel. How to Apply: Interested candidates are invited to submit their resume and cover letter to roopa.shree@qinecsa.com Show more Show less