Product Life Group is a consultancy firm that specializes in product management and delivery, helping organizations optimize their product life cycles through tailored strategies and methodologies.
Not specified
INR 13.0 - 18.0 Lacs P.A.
Work from Office
Full Time
SharePoint and Copilot Deployment and Adoption : Lead the deployment and adoption of SharePoint and Copilot across the organization, ensuring it aligns with business needs and enhances collaboration, document management and user productivity. Community Empowerment : Empower and train the SharePoint site owners and Copilot communities to effectively manage and utilize SharePoint sites and Copilot. Governance Framework : Define and implement a governance framework for managing SharePoint, ensuring compliance with organizational policies and standards. Migration Leadership : Lead the migration of existing SharePoint environments to the targeted framework, ensuring minimal disruption and optimal performance. Environment Integrity : Ensure the integrity of the SharePoint environment by implementing robust security measures, monitoring performance, and troubleshooting issues. Collaboration and Integration : Collaborate with cross functional teams to integrate SharePoint with other Microsoft Modern Workplace solutions such as Teams, OneDrive, Copilot and Azure Active Directory. System Maintenance : Perform regular system maintenance, including updates and upgrades. Documentation and Knowledge Management : Develop and maintain technical documentation related to SharePoint configurations, processes, and best practices. Copilot Integration : Assist in developing use cases and integrate Microsoft Copilot to automate tasks, enhance productivity, and provide AI-driven insights leveraging the Microsoft ecosystem. Agent AI Development : Develop and deploy Agent AI solutions to automate workflows, improve decision-making, and enhance user experience across the organization. Required education: Bachelor s degree in Computer Science, Information Technology, or a related field. Required experience : Minimum of 3 years of experience in IT, with a focus on Microsoft Modern Workplace technologies. Proven experience in designing, deploying, and managing SharePoint solutions, particularly in an enterprise environment. Familiarity with AI and automation technologies, including experience with Copilot or similar AI tools. Required technical skills: SharePoint Expertise: Strong knowledge of SharePoint Online and On-Premises, including site architecture, governance, and security. Microsoft 365: Proficiency in Microsoft 365 services such as Teams, OneDrive, and Azure Active Directory. Power Platform: Experience with Power Automate (formerly Microsoft Flow) and PowerApps. Scripting and Automation: Proficiency in PowerShell scripting for automating SharePoint tasks. Cloud Platforms: Familiarity with cloud platforms, particularly Azure and Office 365. SQL Server: Basic understanding of SQL Server, as it supports SharePoint databases. AI and Automation: Knowledge of AI technologies, including Microsoft Copilot and Agent AI development frameworks.
Not specified
INR 4.0 - 6.0 Lacs P.A.
Work from Office
Full Time
ProductLife Group is looking for Medical Reviewers, having 2-3 years of experience with MBBS/MD degree. Responsibilities: We are looking for a medical reviewer proficient in post-marketing drug safety. Post-Marketing (Pharmacovigilance) Medical review of the ICSRs (Spontaneous, literature, clinical studies) Support in seriousness assessment, Initial Triage Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. perform additional review of cases to ensure competency. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members on good assessment of the cases and MedDRA coding Required Education: MBBS, or MD (Doctor of Medicine) Required Experience: Client communications Safety Database experience Minimum 2-4 years experience working for service providers or pharmaceutical company in Pharmacovigilance department Additional experience and/or skills:: Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Clinical experience an advantage Ability to deliver constructive feedback Emotional intelligence Adaptability Analytical skills Flexibility Reliable Strong organisation skills Punctual Database experience
Not specified
INR 8.0 - 11.0 Lacs P.A.
Work from Office
Full Time
PRODUCTLIFE Group is looking for Medical Reviewer to join our dynamic team and embark on a rewarding career journey. Medical Reviewer VAF 192, 193, 194 is responsible for overseeing and optimizing medical reviewer vaf 192, 193, 194 operations. This role involves strategic planning, team coordination, and execution of tasks to ensure efficiency and productivity. The incumbent will collaborate with stakeholders to align operations with business goals. Duties include monitoring performance, ensuring compliance with policies, and implementing best practices. Additionally, they will manage resources, resolve operational challenges, and contribute to continuous improvement initiatives. Strong analytical skills, leadership abilities, and industry knowledge are essential for success in this role.
Not specified
INR 6.0 - 9.0 Lacs P.A.
Work from Office
Full Time
PRODUCTLIFE Group is looking for Medical Advisor VAF 173 to join our dynamic team and embark on a rewarding career journey. Medical Advisor VAF 173 is responsible for overseeing and optimizing medical advisor vaf 173 operations. This role involves strategic planning, team coordination, and execution of tasks to ensure efficiency and productivity. The incumbent will collaborate with stakeholders to align operations with business goals. Duties include monitoring performance, ensuring compliance with policies, and implementing best practices. Additionally, they will manage resources, resolve operational challenges, and contribute to continuous improvement initiatives. Strong analytical skills, leadership abilities, and industry knowledge are essential for success in this role.
Not specified
INR 2.0 - 5.0 Lacs P.A.
Work from Office
Full Time
PRODUCTLIFE Group is looking for Pharmacovigilance Coordinator (Data Officer) to join our dynamic team and embark on a rewarding career journey. Pharmacovigilance Coordinator (Data Officer) 199 is responsible for overseeing and optimizing pharmacovigilance coordinator (data officer) 199 operations. This role involves strategic planning, team coordination, and execution of tasks to ensure efficiency and productivity. The incumbent will collaborate with stakeholders to align operations with business goals. Duties include monitoring performance, ensuring compliance with policies, and implementing best practices. Additionally, they will manage resources, resolve operational challenges, and contribute to continuous improvement initiatives. Strong analytical skills, leadership abilities, and industry knowledge are essential for success in this role.
Not specified
INR 7.0 - 9.0 Lacs P.A.
Work from Office
Full Time
Role Description: The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality, and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of GMP Clearance applications as well as a range of compliance documents or related quality activities. The Associate Consultant also supports the delivery of a variety of projects, working closely with the Regulatory, Quality & Compliance Administrators, Associates, Associate Consultants, Consultants, Senior Consultants, Manager, Senior Manager, and/or Head of Business Unit to deliver a superior client experience and optimize project outcomes. Role Responsibilities: Adherence to ProductLife Group s values, policies, and quality management systems. Perform compliance activities to meet ProductLife Group and client Quality objectives. Support audit requests as required. Manage and prepare GMP clearance applications for submission to the TGA and/or other regulatory agencies, as required. Provide regulatory, quality, and compliance support to clients relating to the registration/listing of pharmaceuticals, biologicals, and medical devices and the ongoing maintenance of these. Assist clients in responding to agency questions. Provide support to clients by assisting more senior members of the team with regulatory, quality, and compliance activities. Prepare, review, and update quality documentation. Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering. Qualifications / Experience / Skills: Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline. A minimum of 3 years of experience in Australian and New Zealand Quality or Regulatory Affairs, preferably in a commercial environment. Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures is preferable. Reasonable computer literacy. Proven experience dealing with a high level of confidentiality. Good problem-solving and project management skills. Ability to work to deadlines. Attention to detail. Excellent written and spoken communication and interpersonal skills. Interest in the practice of consulting. An appetite for learning and development.
Not specified
INR 7.0 - 9.0 Lacs P.A.
Work from Office
Full Time
We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. Responsibilities: Clinical Phase: Lead as a medical monitor/Medical expert Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential. Review and provide feedback on study protocols as needed. Deliver therapeutic area training for all case processing team. May require 24/7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients. Drafting medical monitoring plans (MMP) and ensuring compliance. Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation). Make assessments on SUSAR reportability. Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required). Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases. Post-Marketing (Pharmacovigilance): Lead the medical reviewers Medical review of the ICSRs (Spontaneous, literature) Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. Mentor junior medical reviewers and perform additional review of cases to ensure competency. Provide feedback and ongoing workshops to develop the medical reviewers. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members Required Education: MBBS, or MD (Doctor of Medicine) Required Experience : Experience in leading medical review teams Client communications Safety Database experience Minimum 10 years experience working for service providers or pharmaceutical company At least 5-7 years of experience as a Medical Monitor or clinical phase Required Technical Skills: Microsoft package Pharmaceutical background - strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety. Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment. Working knowledge of EDC systems Good Medical knowledge and Pharmacology understanding
Not specified
INR 4.0 - 6.0 Lacs P.A.
Work from Office
Full Time
Responsibilities : - Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations. Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards. Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines. Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies. Develop and compile PDE and OEL monographs to support safety evaluations. Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions. Manage preclinical studies and associated documentation to ensure compliance and accuracy. Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines. Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment. Provide expert guidance in addressing client and regulatory inquiries effectively. Background Required - Qualified Toxicologist Signing non-clinical/ toxicological reports/ modules/ expert reports Drafting of Environmental risk assessment reports Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc Drafting and review of non-clinical CTD modules Drafting of PDE reports Toxicological risk assessment of impurities/ leachables/ extractables Required education: Qualified and experienced Toxicologist Required experience : At least 2 years of experience in above mentioned activities.
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