This role serves as the key business liaison between Global Medical Safety (GMS) and Information Technology (IT) to ensure the smooth operation and operational planning of Pharmacovigilance (PV) Systems. Responsibilities include business ownership of PV Systems, overseeing daily operations, managing corrective and preventive actions (CAPAs), and maintaining data accuracy and integrity within PV systems. The position requires extensive knowledge of evolving global PV regulations and the ability to assess their impact on processes, systems, and data management. This role is also responsible for identifying and implementing innovative solutions that improve compliance, efficiency, and quality across PV processes, systems, and interfaces. Operational Management: Coordinate with stakeholders to ensure efficient day-to-day operations of PV Systems, in alignment with global business requirements. Coordinate the resolution of any operational issues or system defects that arise after system releases or upgrades. Work closely with IT and business units to track and resolve any deviations, ensuring minimal disruption to PV processes and ongoing system functionality. Execute post-go-live monitoring plans to ensure that all system deployments are functioning as expected. Identify any performance gaps or system deficiencies and escalate these issues as needed. Ensure adherence to PV systems data standards, promoting data accuracy, consistency, and compliance across all systems and processes. Manage the integrity of the data within the safety database, including managing database transfers into the safety database Manage operational projects impacting the safety systems and associated processes Systems Compliance: Lead investigations into any late safety case reports, identifying root causes, and implementing corrective actions to prevent future occurrences. Collaborate with IT and cross-functional teams to ensure timely and effective closure of CAPAs, maintaining adherence to timelines and standards. Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File. Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups. Participate in PV Audits and Inspections Business Ownership: Support the maintenance of GxP/GMP compliance for PV systems, ensuring day-to-day operational adherence to global industry regulations under the guidance of senior leadership. Coordinate the resolution of post-release system issues ensuring timely escalation and resolution in line with business priorities. Assess the impact of emerging global regulations on PV systems, data integrity, and operational standards. Recommend remedial actions to maintain compliance and data quality. Innovation: Work with IT and cross-functional teams to implement innovative solutions in alignment with strategic goals set by leadership. Training and Development: Maintain knowledge of department policies and procedures Complete development activities as applicable Maintain 100% compliance in all assigned training activities Maintain industry and regulatory knowledge Other requirements: Perform additional duties as required to support business needs, including special projects, cross-functional initiatives, and emerging priorities Maintains compliance with company guidelines and HR policies. Minimum Qualification Education: BA or BSc degree in either an IT related field or health related field or other related scientific degree/qualification Industry & Project experience: Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports, demonstrated by a minimum of 5 to 7+ years experience Knowledge and experience with single case safety reporting processes and regulatory compliance, and experience of international safety reporting /regulations Management/Leadership experience: Ability to lead cross-functional groups. Ability to coordinate across multiple centers Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently Change Management: Ability to lead change Ability to thrive in a global matrix environment Demonstrates strong Credo values Other skills: Excellent verbal, written and presentation skills Excellent computer skills (e.g. standard MS Office tools) Strong understanding of IT systems that support the entire PV process Teamwork and collaboration

Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. Qualification, experience & skills: Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 2 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written.

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Job Summary The Process Specialist-CDM/PV role involves managing and optimizing processes within Pharma Research & Development. The candidate will contribute to enhancing safety operations and pharmacovigilance case processing. With a hybrid work model and rotational shifts the role demands adaptability and technical expertise. The position does not require travel. Responsibilities Oversee the management and optimization of processes within Pharma Research & Development to ensure efficiency and compliance. Provide support in pharmacovigilance case processing ensuring accurate and timely documentation of safety data. Collaborate with cross-functional teams to enhance safety operations and improve overall process effectiveness. Analyze data and generate reports to support decision-making and strategic planning in pharmacovigilance activities. Implement best practices and innovative solutions to streamline processes and improve productivity. Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Facilitate communication and coordination between different departments to achieve seamless workflow and process integration. Monitor and evaluate process performance identifying areas for improvement and implementing corrective actions. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues minimizing disruptions and ensuring smooth operations. Contribute to the continuous improvement of processes by providing insights and recommendations based on data analysis. Engage in rotational shifts to provide consistent support and coverage across different time zones. Qualifications Possess a strong background in Pharma Research & Development with experience in pharmacovigilance case processing. Demonstrate proficiency in safety operations and regulatory compliance within the pharmaceutical industry. Exhibit excellent analytical skills and the ability to interpret complex data sets for informed decision-making. Show adaptability to work in a hybrid model and manage rotational shifts effectively. Have a keen eye for detail and a commitment to maintaining high standards of quality and accuracy. Display effective communication skills to collaborate with cross-functional teams and stakeholders. Be proactive in identifying process improvements and implementing innovative solutions. Hold a relevant degree in pharmaceutical sciences or a related field. Have a minimum of 2 years and a maximum of 4 years of experience in the pharmaceutical industry. Experience in PV Case Processing and Safety Ops is considered a valuable asset. Demonstrate the ability to work independently and as part of a team to achieve organizational goals. Show commitment to continuous learning and professional development in pharmacovigilance and safety operations. Be familiar with industry-standard software and tools used in pharmacovigilance and process management. Show more Show less

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance. Show more Show less

Aster Medcity is looking for Registered Nurse to join our dynamic team and embark on a rewarding career journey. Supervise nursing staff in a hospital or clinical settings. Oversee patient care, make management and budgetary decisions, set work schedules, coordinate meetings, and make personnel decisions. Recruit and train nurses and other health care professionals and maintain a facilitys records. Work with staff to apply emerging nursing theories to care delivery. Also implement state and federal regulatory guidelines for patient safety and educate staff about any changes in the laws and how they impact care delivery.

Primary Job Function Responsible for the maintenance and support of the PV Global Safety Database and associated systems. Core Job Responsibilities Application support for all validated IT applications used by Global Pharmacovigilance (GPV) Consulting users to define best solutions for business requirements Managing and conducting optimization and upgrade projects Acting as an interface between GPV, Abbott IT, and software vendors Communicating with external service providers and software vendors Functionally managing external team members and ensuring adherence to defined processes Supervisory/Management Responsibilities Direct Reports : None Indirect Reports : None Position Accountability/Scope Maintain the Global Safety Database and other IT applications used by GPV in a validated state Works with supervision and guidance Minimum Education Degree in IT, documentation sciences, or comparable education Good command of the English language Minimum Experience/Training Required Minimum 5 years experience in maintaining Safety databases (preferably ARISg) - mandatory IT experience in the pharmaceutical industry and validation experience - mandatory Excellent understanding of PV processes and regulatory requirements Advanced IT and programming skills: SQL, Oracle, Java, XML Strong communication and presentation skills in English Training as per assigned ISOtrain curriculum JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Medical Information Writer role is responsible for writing technical responses such as letters or frequently asked questions (FAQs) to be used to answer enquiries received by Medical Information. This may involve updating existing responses or writing new standard responses. Production of other documents may be required. Essential Functions Include:Medical Information service delivery Extensive training, supervision, mentoring and advice will be provided to support the Medical Information Writer in the conduct of the designated responsibilities listed below: Carrying out comprehensive and accurate literature searches in Medline, or other databases as required, for technical medical information letters or documents. Preparing medical information letters and other documents using information gathered from literature searches or similar technical information. This may require condensing large amounts of technical data into concise and readable standard documents. Updating existing written documents, by checking the information within them is still accurate and up to date, and adding new information identified from literature searches in the most appropriate places to ensure readability and technical flow. Ensuring that all written items are accurate, readable and technically proficient and comply with ProPharma SOPs and the requirements of the client as defined in client specific Working Practices. Quality Assurance Quality checking own work and checking simple documents of others within the team under guidance to ensure standards are met and maintained. General Maintaining awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of medical information within the pharmaceutical and healthcare industries. Ensuring that the Confidentiality Statement within the Contract of Employment is adhered to at all times in respect of the data and property of ProPharma and its clients. Ensuring that any confidential information or personal data related to ProPharma, and its clients is managed in accordance with Data Privacy regulations as described in ProPharma Standard Operating Procedures (SOPs) Working in a professional manner at all times with clients, customers, team members and management. Other duties as assigned. Qualified Candidates Must Have A human life sciences degree. Excellent written communication skills Computer literacy. Sound planning, prioritising and organisational skills. Excellent accuracy and attention to detail. Able to work within a team in an open and professional manner. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** 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.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Main tasks: Conduct Medical Review and assessment of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP’s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Qualification, experience & skills: Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 2 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

We are looking for Team Manager Pharmacovigilance to join our team in India on a permanent basis. All over the world, decision-makers depend on us for the essential knowledge that can justify their strategies, promote outstanding research and business growth, and keep them abreast of the market. You’ll join our Life Sciences & Healthcare Pharmacovigilance team responsible for the curation of drug safety information collected from journals, congress publications and drug regulatory approvals which are delivered to OFF-X, a translational drug safety intelligence portal that allows users to easily identify new drug and target safety liabilities. About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Toxicology, Pharmacology, Biology, Pharmacy, Biomedical Sciences, etc.) and experience in pharmacovigilance, drug safety management and/or toxicology At least 5 years’ experience in a global corporation (pharma domain or consulting) with people and process management experience Excellent written and oral communication skills in English. It would be great if you also had . . . Demonstrated ability to work collaboratively in a matrixed organization. Good judgment in decision-making and priority setting. Ability to analyze processes, identify problems, and develop effective solutions. Capability to work remotely with peers in an international environment. Ability to delve deep into content and results. What will you be doing in this role? Create a culture of success, motivating, and developing colleagues to achieve their full potential. Drive execution and performance. Ensure key performance indicators for quality, timeliness and completeness are delivered and strive for continuous improvement. Build a customer-focused team and develop an environment which stimulates innovation. Play a role in major decisions and initiatives to enable the Content Function to achieve its long-term objectives. Communicate initiatives to senior management, set timelines and manage expectations for all deliverables and releases. Work together with Product, Product Operations, Technology and Marketing in the product development process Identify opportunities for synergies and simplification of complex processes. About The Team You’ll be reporting to the Director, Content Editing, based in France and join an international and diverse team of more than 80 colleagues mostly based in Spain and India The OFF-X team is composed of around 20 colleagues mostly based in India The team culture is dynamic, creative, and supportive – excellence, integrity, and care are in our DNA. You’ll have 40 annual paid hours of volunteering time and the chance of being part of an active volunteering community which promotes diversity and inclusion across the business. Hours of Work 40 hours in a week as an FTE Location - Chennai and Noida At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

As a Specialist Software Engineer, you will join a collaborative team developing and implementing the next generation of safety platforms and supporting technologies. In this role, you will be responsible for designing, developing, and deploying complex software applications and mentoring junior developers. You will work closely with the business to develop high-quality, scalable, and maintainable solutions. Roles & Responsibilities: Design, develop, and deploy applications to support pharmacovigilance systems. Develop and maintain solutions to enhance E2E data reconciliation, ensuring consistency and accuracy across systems related to adverse events/product complaints. Develop innovative solutions using generative AI technologies, including large language models (LLMs) like Open AI GPT for enhanced decision-making and driving efficiency. Using strong rapid prototyping skills, quickly translate concepts into working code. Conduct code reviews to ensure code quality and consistency to standards. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges effectively. Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes. Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-safety systems. Find opportunities for automation and process improvements within the drug-safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems Change Control and GxP validation process. Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines. Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver best practice solutions. Responsible for supporting technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues. Basic Qualifications and Experience: Master's degree with 4 to 6 years of experience in Computer Science, software development, or a related field; OR Bachelor's degree with 6 to 8 years of experience in Computer Science, software development, or a related field; OR Diploma with 10 to 12 years of experience in Computer Science, software development, or a related field. Functional Skills: Must-Have Skills: Experienced in database programming languages, data modeling concepts, including such as Oracle SQL and Postgres. Experienced with reporting tools such as Tableau, Cognos, Business Objects. Experienced in one or more general programming languages, including but not limited to Java or Python. Excellent problem-solving skills and a commitment to resolving challenges. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP), and Natural Language Generation (NLG) automation technologies with building business requirements. Extensive experience with SDLC. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experience with Application Programming Interface (API integrations) such as MuleSoft and Extract Transform Load (ETL) tools as Informatica platform, and Databricks. Outstanding ability to explain technical concepts to non-technical clients. Good-to-Have Skills: 3+ years of experience with COTS Pharmacovigilance Platforms (for example Argus) or other safety databases. Experienced in managing GxP systems and implementing GxP projects. Professional Certifications: Certified SAFe Agile Software Engineer. Soft Skills: Strong verbal and written communication skills. Excellent analytical and problem-solving skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to deal with ambiguity and prioritize. Team-oriented, with a focus on achieving team goals. Ability to influence and drive to an intended outcome and hold peers accountable, and work effectively with global, virtual teams. Ability to hold peers accountable to commitments. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Review and execute physician’s prescriptions checking their appropriateness and legality. Maintain full control over delivering, stocking and labeling medicine and other products and monitor their condition to prevent expiring or deterioration. Required Candidate profile Thorough understanding of dosage administration and measurement, chemical compounds, medical brands etc. Excellent communication skills with a customer oriented approach. Integrity and compassion. Perks and benefits Health insurance Retirement plans Paid time off

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Product Safety Job Sub Function Drug & Product Safety Operations Job Category Professional All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India Job Description Job Title - Manager, PV Safety System Essential Job Duties And Responsibilities This role serves as the key business liaison between Global Medical Safety (GMS) and Information Technology (IT) to ensure the smooth operation and operational planning of Pharmacovigilance (PV) Systems. Responsibilities include business ownership of PV Systems, overseeing daily operations, managing corrective and preventive actions (CAPAs), and maintaining data accuracy and integrity within PV systems. The position requires extensive knowledge of evolving global PV regulations and the ability to assess their impact on processes, systems, and data management. This role is also responsible for identifying and implementing innovative solutions that improve compliance, efficiency, and quality across PV processes, systems, and interfaces. Operational Management Coordinate with stakeholders to ensure efficient day-to-day operations of PV Systems, in alignment with global business requirements. Coordinate the resolution of any operational issues or system defects that arise after system releases or upgrades. Work closely with IT and business units to track and resolve any deviations, ensuring minimal disruption to PV processes and ongoing system functionality. Execute post-go-live monitoring plans to ensure that all system deployments are functioning as expected. Identify any performance gaps or system deficiencies and escalate these issues as needed. Ensure adherence to PV systems data standards, promoting data accuracy, consistency, and compliance across all systems and processes. Manage the integrity of the data within the safety database, including managing database transfers into the safety database Manage operational projects impacting the safety systems and associated processes Systems Compliance Lead investigations into any late safety case reports, identifying root causes, and implementing corrective actions to prevent future occurrences. Collaborate with IT and cross-functional teams to ensure timely and effective closure of CAPAs, maintaining adherence to timelines and standards. Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File. Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups. Participate in PV Audits and Inspections Business Ownership Support the maintenance of GxP/GMP compliance for PV systems, ensuring day-to-day operational adherence to global industry regulations under the guidance of senior leadership. Coordinate the resolution of post-release system issues ensuring timely escalation and resolution in line with business priorities. Assess the impact of emerging global regulations on PV systems, data integrity, and operational standards. Recommend remedial actions to maintain compliance and data quality. Innovation Work with IT and cross-functional teams to implement innovative solutions in alignment with strategic goals set by leadership. Training And Development Maintain knowledge of department policies and procedures Complete development activities as applicable Maintain 100% compliance in all assigned training activities Maintain industry and regulatory knowledge Other Requirements Perform additional duties as required to support business needs, including special projects, cross-functional initiatives, and emerging priorities Maintains compliance with company guidelines and HR policies. Minimum Qualification Education BA or BSc degree in either an IT related field or health related field or other related scientific degree/qualification Industry & Project Experience Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports, demonstrated by a minimum of 5 to 7+ years experience Knowledge and experience with single case safety reporting processes and regulatory compliance, and experience of international safety reporting /regulations Management/Leadership Experience Ability to lead cross-functional groups. Ability to coordinate across multiple centers Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently Change Management Ability to lead change Ability to thrive in a global matrix environment Demonstrates strong Credo values Other Skills Excellent verbal, written and presentation skills Excellent computer skills (e.g. standard MS Office tools) Strong understanding of IT systems that support the entire PV process Teamwork and collaboration Show more Show less

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Product Safety Job Sub Function Drug & Product Safety Operations Job Category Professional All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India Job Description Job Title - Manager, PV Safety System Essential Job Duties And Responsibilities This role serves as the key business liaison between Global Medical Safety (GMS) and Information Technology (IT) to ensure the smooth operation and operational planning of Pharmacovigilance (PV) Systems. Responsibilities include business ownership of PV Systems, overseeing daily operations, managing corrective and preventive actions (CAPAs), and maintaining data accuracy and integrity within PV systems. The position requires extensive knowledge of evolving global PV regulations and the ability to assess their impact on processes, systems, and data management. This role is also responsible for identifying and implementing innovative solutions that improve compliance, efficiency, and quality across PV processes, systems, and interfaces. Operational Management Coordinate with stakeholders to ensure efficient day-to-day operations of PV Systems, in alignment with global business requirements. Coordinate the resolution of any operational issues or system defects that arise after system releases or upgrades. Work closely with IT and business units to track and resolve any deviations, ensuring minimal disruption to PV processes and ongoing system functionality. Execute post-go-live monitoring plans to ensure that all system deployments are functioning as expected. Identify any performance gaps or system deficiencies and escalate these issues as needed. Ensure adherence to PV systems data standards, promoting data accuracy, consistency, and compliance across all systems and processes. Manage the integrity of the data within the safety database, including managing database transfers into the safety database Manage operational projects impacting the safety systems and associated processes Systems Compliance Lead investigations into any late safety case reports, identifying root causes, and implementing corrective actions to prevent future occurrences. Collaborate with IT and cross-functional teams to ensure timely and effective closure of CAPAs, maintaining adherence to timelines and standards. Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File. Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups. Participate in PV Audits and Inspections Business Ownership Support the maintenance of GxP/GMP compliance for PV systems, ensuring day-to-day operational adherence to global industry regulations under the guidance of senior leadership. Coordinate the resolution of post-release system issues ensuring timely escalation and resolution in line with business priorities. Assess the impact of emerging global regulations on PV systems, data integrity, and operational standards. Recommend remedial actions to maintain compliance and data quality. Innovation Work with IT and cross-functional teams to implement innovative solutions in alignment with strategic goals set by leadership. Training And Development Maintain knowledge of department policies and procedures Complete development activities as applicable Maintain 100% compliance in all assigned training activities Maintain industry and regulatory knowledge Other Requirements Perform additional duties as required to support business needs, including special projects, cross-functional initiatives, and emerging priorities Maintains compliance with company guidelines and HR policies. Minimum Qualification Education BA or BSc degree in either an IT related field or health related field or other related scientific degree/qualification Industry & Project Experience Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports, demonstrated by a minimum of 5 to 7+ years experience Knowledge and experience with single case safety reporting processes and regulatory compliance, and experience of international safety reporting /regulations Management/Leadership Experience Ability to lead cross-functional groups. Ability to coordinate across multiple centers Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently Change Management Ability to lead change Ability to thrive in a global matrix environment Demonstrates strong Credo values Other Skills Excellent verbal, written and presentation skills Excellent computer skills (e.g. standard MS Office tools) Strong understanding of IT systems that support the entire PV process Teamwork and collaboration Show more Show less

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Mumbai : BKC Building t

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Bangalore : Jigani Link Road t

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Hyderabad : No 1-6-140 t

Job Details Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future risk minimisation activities for the entire life cycle of the product. Reviewing the documents, checking for completeness and consistency, and evaluating the report quality. Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Ensure client satisfaction and compliance with legal and regulatory requirements. Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project. Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. . Qualifications: Bachelors or Masters degree in Pharma, Lifesciences Experience: 4-8 years in Writing Risk Management Plans (RMPs) Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future risk minimisation activities for the entire life cycle of the product. Reviewing the documents, checking for completeness and consistency, and evaluating the report quality. Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Ensure client satisfaction and compliance with legal and regulatory requirements. Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project. Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. . Qualifications: Bachelors or Masters degree in Pharma, Lifesciences Experience: 4-8 years in Writing Risk Management Plans (RMPs) Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Education: B.SC/M.SC/B.Pharm/M.Pharm Job Description: Multiple mailboxes handling, fluent in English (written/verbal communications), proactive for communications, Co-ordinating with clients as first contact point for routine communications, support during audits/inspections Basic knowledge of pharmacovigilance we'll versed with MS outlook, Powerpoint, Excel. COMPETENCIES Accountability Communication Work Ethic Leadership Presentation / Communication skills Organizational Culture fit

My profile :- linkedin.com/in/yashsharma1608 1. SALESFORCE DEVELOPER With PHARMACOVIGILANCE Job Title: Salesforce Developer Payroll of :- https://www.nyxtech.in/ Client name - Qbranix Exp level - 4 to 7 years Location : Pune Resource Type: Contract Type of work: 6 month initially and extended based on the project Start Date: Immediate - PF Mandatory Budget - 15 LPA Mandatory Qualifications: Experience Pharmacovigilance (PV) and Safety area of the pharmaceutical industry. Job Description: We are seeking one mid-level Salesforce Developers for a 6-month project to support Client Product, a leading global provider of advanced analytics, technology solutions, and contract research services. The ideal candidates will have experience in the Pharmacovigilance (PV) and Safety area of the pharmaceutical industry. Key Responsibilities: Develop and customize Salesforce applications to meet project requirements. Ensure seamless integration with existing systems and workflows. Provide technical support and troubleshooting as needed. Requirements: Proven experience as a Salesforce Developer. Familiarity with Pharmacovigilance and Safety (PV/Safety) in the pharmaceutical industry. Strong understanding of Salesforce platform and its capabilities. Excellent communication and teamwork skills.

Company Overview: We are an AI-first company delivering cutting-edge, SaaS-based solutions for the pharmacovigilance and life sciences industries. Our AI/ML-powered products - such as DF mSafety AI, DF mSignal AI and DF Literature Monitor - help pharmaceutical and healthcare organizations automate the tracking, management, and analysis of safety data. By streamlining safety case processing and signal detection, we empower companies to ensure patient safety, meet global regulatory requirements, and drive better health outcomes. We are seeking a dynamic, experienced Sr. Marketing Manager to lead our marketing strategy. Role Overview: We are seeking a highly experienced Senior Marketing Manager to be part of the global marketing efforts for our enterprise SaaS solutions within the pharmacovigilance and healthcare domains. This individual will play a pivotal role in shaping and executing go-to-market strategies, driving product positioning, and enabling cross-functional alignment to support global expansion and customer engagement. This role requires a unique combination of deep domain expertise in pharmacovigilance or healthcare, a strong SaaS marketing background, and a proven track record of executing global marketing strategies for complex, enterprise-grade software products. Key Responsibilities: · Go-To-Market (GTM) Strategy & Execution: Develop and lead global GTM strategies for SaaS products, ensuring alignment with sales, product, and customer success teams. · Product Positioning & Messaging: Craft compelling, differentiated messaging that resonates with stakeholders in pharmaceutical companies, CROs, and regulatory agencies. · Campaign Development & Demand Generation: Design and execute integrated marketing campaigns to drive awareness, engagement, and lead generation across multiple geographies. · Sales Enablement: Create sales collateral, competitive battle cards, product presentations, and training materials to support sales and field marketing teams. · Market Intelligence & Competitive Analysis: Monitor market trends, competitor activities, and regulatory changes in the pharmacovigilance and healthcare sectors to inform strategy. Cross-functional Leadership: Collaborate with Product Management, Sales, and Regulatory Affairs to ensure marketing initiatives are aligned with business objectives. · Event & Thought Leadership Marketing: Represent the company at industry conferences, webinars, and other thought leadership forums; drive speaking opportunities and content creation. Required Qualifications, Experience & Skills: · 8–12 years of progressive experience in B2B SaaS product marketing, preferably within the pharmaceutical, healthcare, or life sciences sectors. · Proven track record of developing and executing global marketing strategies for enterprise-level software products. · Deep understanding of pharmacovigilance processes, regulatory compliance (FDA, EMA), and key industry stakeholders (e.g., pharma, CROs, regulators). · Strong expertise in GTM strategy, product lifecycle marketing, and market segmentation. · Exceptional written and verbal communication skills with the ability to translate complex concepts into clear, customer-focused messaging. · Experience working in a high-growth, matrixed environment with global teams. · Bachelor’s degree in marketing, Life Sciences, Business, or related field. MBA or advanced degree is a plus. · Experience with marketing automation platforms, CRM tools (e.g., Salesforce), and analytics platforms. Join our team at Datafoundry to be part of an exciting journey as we revolutionize the way organizations leverage data to gain a competitive advantage. We offer an attractive compensation and bonus package, a flexible remote work environment, and ample opportunities for professional growth. Show more Show less

Senior Auditor, Quality Assurance (Remote Based) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies. Job Location: Bangalore (Remote Based) Responsibilities And Qualifications Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations. Lead/Support regulatory Inspection hosting Lead/Support Sponsor Audit Hosting Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management Manage Quality Issues Lead Quality Issue Investigations Supports Operations in Root Cause Analysis and CAPA Plan preparation. Support Effectiveness Check development and outcomes. Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team. Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations. Mentor new or developing Q&C staff as assigned. Support business development activities and Q&C initiatives as needed. Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host Host Sponsor audit ICON as Lead Host or Co-host What You Will Have 5 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry. Advanced knowledge of GCP (Good Clinical Practice) Excellent organizational skills. Must possess a technical knowledge that is applicable to clinical drug development. An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel). Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances. Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision Read, write and speak fluent English. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less