Team Lead, Pharmacovigilance Safety System
4 months ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
This position is a member of Global Patient Safety – Pharmacovigilance Compliance and Safety Operations -PV Technology and Systems support team. This position is a Team Lead position and is responsible for supervision of the Systems Support team. This position is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking. This role implements user requirements and acts as a technical expert for managing system requests and updates to codelists and libraries. This position works with internal GPS functional areas as well as vendor resources to review and implement medium to complex change requests including updates to reporting rules.
The team lead ensures that PV Technology and Systems support operations are appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to pharmacovigilance.
Responsibilities include, but are not limited to the following:
Supporting the maintenance of current pharmacovigilance safety system (ARGUS and PVQ). Ability to work flexible hours supporting users in different time zones. May need to work in shifts as needed/assigned. Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine changes and Change Requests). Initiation, review and notification of routine changes to pharmacovigilance safety system. Review and analysis of user requirements prior to submission and implementation, participate in validation activities as required. Perform periodic review of administrator data including but not limited to user access, company product dictionary and Safety Data Exchange agreements. Ensure that changes made to the databases are controlled through the change control process. Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional area prior to processing for implementation Responsible for creating, verifying and tracking complex change requests, including updates to reporting rules, product lists and code lists. Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changes Partner in the development of system-related training programs and deliver training Maintain and manage SharePoint sites used for tracking systems requests (Routine changes and Change Requests) Take initiative to recognize, prioritize & escalate potential safety/ compliance issues Train and develop other team members in area of Systems support and database configuration Manage day to day tasks and assignments of team members, be an individual contributor as well as the leader of the teamEscalate any team issues to management as appropriate
-
Safety Systems Manager
3 weeks ago
Bengaluru, India VCLS Full timeSafety Systems ManagerVCLS is seeking a talented and experienced Safety Systems Manager to join our team. As a Safety Systems Manager, you will be responsible for overseeing the safety systems, processes, and technologies at VCLS, ensuring compliance with regulatory requirements and driving continuous improvement in safety management. Join us and contribute...
-
Pharmacovigilance Processes, Partnerships and
3 months ago
Bengaluru, India AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
-
Mgr Pharmacovigilance
3 months ago
Bengaluru, India Teva Pharmaceuticals Full timeThe opportunityAs Pharmacovigilance Manager, within the ICSR operations sub-function within Patient Safety Operations (PSO), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) reports to the Head of ICSR Operations; Responsible for having an overview of ICSR process and quality and ensure the...
-
Safety Reporting Coordinator
3 months ago
Bengaluru, India Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Safety Reporting Coordinator
4 months ago
Bengaluru, India Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Safety Manager
2 weeks ago
Bengaluru, India Excelya Full timeExcelya Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...
-
Safety Manager
2 weeks ago
Bengaluru, India Excelya Full timeExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Safety Manager
2 weeks ago
Bengaluru, India Excelya Full timeExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Drug Safety Physician
3 months ago
Bengaluru, India Merck KGaA Darmstadt Germany Full timeWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Expert Safety Medical Writer
3 months ago
Bengaluru, India Merck KGaA Darmstadt Germany Full timeWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Safety Reporting Coordinator
3 months ago
Bengaluru, Karnataka, India Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Deputy Affiliate Safety Representative
4 months ago
Bengaluru, India ABBVIE Full time**Job Summary**: To actively support ASR in the coordination and execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie’s statutory and ethical responsibilities are met. Act as Back up for Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient...
-
Safety Writer Ii
4 months ago
Bengaluru, Karnataka, India Thermo Fisher Scientific Full timeSummarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery...
-
Sr System Engineer
2 months ago
Bengaluru, India Maxwell Energy System Pvt Ltd Full timeMaxwell Energy works on advanced electronics focusing on efficient energy storage and conversion solutions. We are looking for a system engineer with a strong desire to make our products safe and reliable yet simple. In this role, you would be responsible for end-to-end process definition, implementation and execution of the best practices of system and...
-
Safety Writer
4 months ago
Bengaluru, India Elixir Consulting Full timeLocation - Bangalore- Industry - Other- Contract Type - Permanent- Salary - ₹ 11,000,000- Published - 5 days ago - Contact - Reference - 29-25-10137- Academic title - Bachelor of ScienceJob description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and...
-
Pharmacovigilance Officer
4 months ago
Bengaluru, India PrimeVigilance Full timeCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Safety Officer
1 week ago
Bengaluru, India Excelya Full timeExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Bengaluru, India Oracle Full timeJob Description `Overview of the Organization Oracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national...
-
Drug Safety Expert I
3 months ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDrug Safety Expert I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety GBS (GS - GBS).- **The Position** - A Drug Safety Expert will be responsible to ensure all the conventions are followed by safety case handlers and would drive quality deliverables, he or she would act as a bridge...
-
Safety Officer
2 weeks ago
Bengaluru, India Excelya Full timeExcelya Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...