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10.0 - 12.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role As a Pharmacovigilance IT Systems Specialist, you will be tasked with supporting, maintaining, and enhancing the pharmacovigilance system to ensure adherence to regulatory standards. You will take the lead in implementing and continuously improving safety databases, ensuring data integrity and compliance with regulations. Collaboration with cross-functional teams will be essential as you integrate new technologies and processes. Additionally, you will act as a primary point of contact for system users and technical teams, overseeing the entire lifecycle of safety system operations. This role is vital for supporting high-priority safety data migration and E2B Gateway exchange projects, contributing to strategic Global Patient Safety initiatives, and managing numerous LSMT platform releases and operational activities. The role will be based in Bangalore, India, and reporting to Team Lead, Pharmacovigilance Services. Who You Are A university degree (Master&aposs or Bachelors) or equivalent in information technology or life sciences, with a strong interest in IT systems. Over 10 years of experience with drug safety database systems in the pharmaceutical industry, healthcare organizations, or software application vendors. In-depth knowledge of LSMV and pharmacovigilance systems, along with drug safety regulatory requirements (ICH, GVP, FDA CFR Part 11, GxP). Strong understanding of software validation processes and methodologies (GAMP). Proven experience in IT project management, service delivery, or vendor management is advantageous. Exceptional organizational skills with the ability to prioritize tasks and quickly adapt to shifting priorities. A collaborative team player who considers the broader goals beyond individual targets. Excellent written and verbal communication skills in English. Strong interpersonal skills in an international setting. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! Show more Show less
Posted 1 day ago
3.0 - 6.0 years
3 - 5 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Diensten Tech Limited is looking for Senior PV Specialist to join our dynamic team and embark on a rewarding career journey Monitor and assess the safety of pharmaceutical products Conduct pharmacovigilance activities and report adverse drug reactions Ensure regulatory compliance in reporting safety data Collaborate with healthcare professionals and research team
Posted 2 months ago
0.0 - 3.0 years
2 - 4 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Roles & Responsibilities: Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with stakeholders to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelors degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Or Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Experience with data transfer processes and tackle stuck or delayed data files. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Knowledge of Validation of systems Good-to-Have Skills: Experience in Pharmacovigilance systems Experience with Signal or Risk Management platforms is a plus Knowledge or some experience in database programming languages such as Oracle SQL and PL/SQL Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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.
Posted 2 months ago
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