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
Job Title: Assistant Manager – Procure to Pay (P2P) Process Location: Mysore – Remote Experience: Minimum 7~10 years Industry: ITES Reports To: P2P Finance Operations Manager Job Summary We are seeking a highly motivated and experienced Assistant Manager – Procure to Pay (P2P) Process professional to lead and optimize the end-to-end P2P cycle. The ideal candidate will have at least 7 years of experience in P2P operations and a strong working knowledge of Oracle NetSuite . He/She will be responsible for ensuring timely Invoice processing, Payment Initiation, Transaction Recording, Vendor Management, Process improvement, Compliance, Reporting, Audit, cross-functional collaboration. Key Responsibilities Manage the entire Procure to Pay across multiple entities andmultiple Geographies including Invoice processing, Payment Initiation, Transaction Recording, Vendor Management and cash application. Lead and support daily P2P operations ensuring accuracy and timeliness of transactions. Utilize Oracle NetSuite as per detailed JD to maintain and analyse vendor account data, generate reports, and streamline workflows. Partner with Business Development, HR, and Vendor, Procurement Service teams to resolve issues. Drive process standardization and continuous improvement initiatives to increase efficiency and reduce cycle times. Ensure compliance with internal controls, policies, and procedures. Monitor and report key performance indicators (KPIs) related to P2P process – AP aging, vendor dispute resolution and coordination with internal and external teams, etc. Interact with team members; act as a subject matter expert (SME) on P2P processes and Oracle NetSuite functionalities. Participate in audits and support internal/external audit requirements. Managing / Overseeing the procurement process from requisition to payment. Ensuring timely and accurate processing of invoices. Coordinating with suppliers and internal teams to resolve any discrepancies. Monitoring compliance with procurement policies and financial regulations. Maintaining accurate records of transactions and audits. Oversee the end-to-end Procure-to-Pay process Develop and implement P2P strategies and policies Manage vendor relationships and contract compliance Ensure timely and accurate processing of purchase orders and invoices Monitor and report on P2P performance metrics Collaborate with cross-functional teams to improve processes Ensure compliance with internal controls and regulatory requirements Support NetSuite system upgrades, customisation Identify and implement process improvements Manage P2P-related audits and risk assessments Resolve escalated issues related to procurement and payments Prepare P2P related audit schedules for internal and external audits, including statutory audits. Accounts Payable Support: Assisting with applying vendor payments paid to the corresponding invoices in NetSuite. Helping to reconcile vendor accounts and resolve simple discrepancies. Supporting the Payments/Treasury team by providing information or sending out standard reminders. Maintaining and updating vendor records in NetSuite with accurate payment information. Data Management and Reporting: Performing data entry and maintaining data integrity within the P2P modules in NetSuite. Running basic reports in NetSuite related to Purchase orders, Purchase invoices, or vendor balances. Assisting with organizing and filing documentation related to P2P transactions. Communication: Communicating with customers regarding basic order and invoice queries (under supervision). Liaising with internal teams (Procurement, HR, IT, Legal, Business Development, Contracts and proposal team) to ensure smooth P2P flow. Key Skills and Knowledge (often developed in an entry-level role): Familiarity with basic accounting principles, particularly accounts receivable. Proficiency in data entry and attention to detail. Basic understanding of the Procure-to-Pay process steps. Ability to navigate and perform basic tasks within NetSuite. Good communication and organizational skills.
As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will be responsible for conducting review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness, relatedness, and assigning appropriate MedDRA codes. Additionally, you will review narratives, assess labeling, and escalate complex case issues to the medical review team when necessary. You must have experience with relevant safety databases and software applications, along with proven customer handling and relationship skills. Task management and people management capabilities are essential for this role. Your presentation skills will be put to use as you communicate effectively within and across client therapeutic teams. It is important to have knowledge of the Life Sciences Industry, drug life cycles, and relevant product and industry information. In this position, you will acquire and maintain current knowledge of product portfolios and safety profiles across therapeutic areas. You will be responsible for identifying and resolving case issues, coordinating with client therapeutic teams, and adhering to applicable Global Health Authority regulations. Moreover, you may be required to contribute to a team environment, demonstrate flexibility, and complete multiple tasks concurrently under stringent timelines. The ideal candidate for this role should possess a relevant educational background, required certifications, and industry experience. Key performance indicators, competencies, knowledge, skills, and abilities play a crucial role in ensuring success in this position. Understanding work environment details, specific requirements, and other job-related information will be essential for carrying out the responsibilities effectively. In summary, as a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will play a vital role in ensuring the safety and regulatory compliance of products across therapeutic areas while effectively managing case reviews, communication with clients, and maintaining knowledge of industry regulations and standards.,
As an experienced professional in the ITES industry with a minimum of 7-10 years of experience, you will be responsible for leading and supporting daily P2P operations to ensure accuracy and timeliness of transactions. Your role will involve utilizing Oracle NetSuite to maintain and analyze vendor account data, generate reports, and streamline workflows. In addition, you will collaborate with various departments such as Business Development, HR, and Vendor Procurement Service teams to address and resolve issues. Your key responsibilities will also include driving process standardization and continuous improvement initiatives to enhance efficiency, ensuring compliance with internal controls, policies, and procedures, and monitoring and reporting key performance indicators (KPIs) related to P2P processes. You will serve as a subject matter expert on P2P processes and Oracle NetSuite functionalities, participate in audits, and support internal/external audit requirements. Furthermore, you will be tasked with ensuring timely and accurate processing of invoices, coordinating with suppliers and internal teams to resolve discrepancies, and monitoring compliance with procurement policies and financial regulations. Your role will involve developing and implementing P2P strategies and policies, managing vendor relationships and contract compliance, and reporting on P2P performance metrics. Collaboration with cross-functional teams to improve processes, support NetSuite system upgrades and customization, identify and implement process improvements, manage P2P-related audits and risk assessments, and prepare audit schedules will also be part of your responsibilities. You will assist in reconciling vendor accounts, maintaining data integrity within the P2P modules in NetSuite, running basic reports, and organizing documentation related to P2P transactions. Key skills and knowledge required for this role include familiarity with basic accounting principles, proficiency in data entry, attention to detail, ability to navigate and perform basic tasks within NetSuite, and good communication and organizational skills. You will also be expected to communicate with customers regarding basic order and invoice queries and liaise with internal teams to ensure a smooth P2P flow. Overall, your role as a seasoned professional in P2P Finance Operations will involve a combination of leadership, technical expertise, and collaboration to drive operational excellence and compliance within the organization.,
The position is based in Mysore with the flexibility of remote work. With a minimum of 7-10 years of experience in the ITES industry, you will be reporting to the P2P Finance Operations Manager. Your primary responsibility will involve leading and supporting daily P2P operations to ensure the accuracy and timeliness of transactions. You will utilize Oracle NetSuite to maintain and analyze vendor account data, generate reports, and streamline workflows as per the detailed job description. Collaborating with various teams such as Business Development, HR, and Vendor Procurement Service, you will drive process standardization and continuous improvement initiatives to enhance efficiency and reduce cycle times. Ensuring compliance with internal controls, policies, and procedures will be critical in your role. Monitoring and reporting key performance indicators related to the P2P process, AP aging, vendor dispute resolution, and coordination with internal and external teams will be essential. As a subject matter expert on P2P processes and Oracle NetSuite functionalities, you will interact with team members and participate in audits to support internal and external requirements. Managing vendor relationships, contract compliance, purchase orders, and invoices processing will be part of your responsibilities. Collaborating with cross-functional teams to enhance processes, ensure compliance with internal controls and regulatory requirements, and support NetSuite system upgrades and customization will be crucial. Your role will also involve identifying and implementing process improvements, managing P2P-related audits and risk assessments, preparing audit schedules for internal and external audits, and assisting in reconciling vendor accounts and resolving discrepancies. Data management and reporting tasks, including data entry, maintaining data integrity, running basic reports in NetSuite, and organizing documentation related to P2P transactions, will also be part of your duties. Effective communication with customers regarding order and invoice queries, as well as liaising with internal teams to ensure a smooth P2P flow, will be essential. Key skills and knowledge, typically developed in an entry-level role, include familiarity with basic accounting principles, proficiency in data entry, attention to detail, navigating NetSuite, and possessing good communication and organizational skills.,
We are currently hiring for DSA I role with a minimum of 1 year experience in case processing. Location : Hybrid Salary Upto : 4 Lakhs INR per annum Essential Duties and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Dug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. 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. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Other skills: The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Qualifications Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) 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 Goal-oriented Ability to maintain professional and positive attitude
As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will be responsible for reviewing and assessing individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within your assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness and relatedness, assigning appropriate MedDRA codes, assessing labeling, and reviewing narratives. It is essential to maintain current knowledge of the product portfolio and safety profiles across therapeutic areas. You will escalate complex case issues to the medical review team when necessary and conduct assessments of litigation cases across assigned products. Effective communication and interaction within client therapeutic teams and functional team management are crucial aspects of this role. Additionally, you will be required to comply with applicable Global Health Authority regulations and perform other drug safety-related activities as assigned. In this position, you are expected to contribute to a team environment with professionalism and skill, demonstrating flexibility in a dynamic, fast-paced, cross-functional setting. The ability to manage multiple tasks concurrently and deliver results under stringent timelines is essential for success in this role. Educational qualifications in a relevant field, along with industry experience and specific certifications, are preferred. Key performance indicators, competencies, knowledge, skills, and abilities required for this role will be outlined to ensure your success as a Medical Safety Physician. The work environment may involve travel, and other specific requirements such as vehicle usage, work permits, contract types, time constraints, compliance-related aspects, and union affiliation will be detailed as per the company's policies and regulations.,
We are hiring!! Open Position : Drug Safety Associate - 1, with a minimum of 1 year experience in case processing. Location : Initially work from home, later will be office based Salary Upto : 4 Lakhs INR per annum Qualifications: Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Roles and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Drug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. 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. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. 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. Goal-oriente and ability to maintain professional and positive attitude.
We are looking for a Solution Design Manager - Pharmacovigilance Signal Detection Solutions to join our team in Noida, India for a 12-month contract. In this role, you will be responsible for leading a team of functional design analysts and consultants to design client solutions for our Qinecsa Vigilance Workbench signal detection platform in the healthcare industry. Your primary focus will be on configuring, migrating, and integrating solutions for pharmacovigilance signal detection, working closely with technical engineers and testing staff to ensure successful implementation. As the Director/Manager of Client Solution Design, you will lead client workshops, gather requirements, and design configuration specifications. You will also be involved in supporting the implementation process, managing scope, and collaborating with cross-functional teams to align with client business and regulatory requirements. Additionally, you will play a key role in coaching and mentoring your team on various projects while also being hands-on in leading large projects. Key Responsibilities: - Manage and guide a team of functional design analysts and consultants - Analyze and document client business requirements - Translate client requirements into product configuration decisions - Document functional requirements for data migrations and customizations - Lead the functional impact assessments of new product versions on existing client solutions - Support incident investigations and change requests as part of BAU services - Collaborate with product management to review product features, defects, and enhancement requests Characteristics: - Well-organized with attention to detail - Strong problem-solving skills - Excellent written and verbal communication skills - Passion for leading and developing a team - Desire to learn and contribute to continuous improvement initiatives Essential Experience and Qualifications: - Bachelor's or Master's degree in computer science, business information systems, biology, nursing, epidemiology, or related fields - Experience in client-facing software implementation with team leadership experience - Understanding of signal detection and signal management practices - Familiarity with computer system validation requirements in life sciences - Ability to lead small teams to meet project timelines Preferred Experience and Qualifications: - Experience in Healthcare or Life Sciences SaaS applications - Familiarity with Empirica Signal / Empirica Topics or similar software systems - Practical understanding of signal detection and management practices - Knowledge of cloud-based solutions - Extensive experience in the life sciences industry (pharma, CRO, or software vendor),
FIND ON MAP