8 Psurs Jobs

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillance Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc. Your role: You are responsible for managing activities related to post-market product safety surveillance and risk management. Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E). Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics. Post Market Surveillance (PMS) Ensures standard PMS processes across business unit is established Assures consistent PMS plans exists for all products Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions). Assures consistent PMS Reports/PSURs for all products. Conduct periodic quality board meeting to review PMS data collected according to the PMS plan and take appropriate actions as necessary to ensure the product remains safe and compliant. support Complaint trending investigation, signal assessment & escalation Assesses significant triggers & safety concerns during periodic quality review meeting and assures standard approach for signal disposition incorporate findings in PMS reports and trigger risk management file update, as required. Patient Safety and Regulatory Reporting In collaboration with Data trending and analytics and Medical Affairs, monitors and assesses safety signals, and recommends actions. Support in assessment of product relationship to reported complaint Assures standard regulatory reporting assessment criteria for PMS activities Provides input to clinical conclusion to be included in the reports to competent authorities. Enable correction & removal decision making by facilitating on time and accurate post market risk assessments. Risk Management Support standard Risk Management processes Facilitate post-market risk assessments including issue impact assessment, health hazard evaluations. Collaborate with cross-functional stakeholders including R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc. to drive meaningful post market risk assessment of issues. Support the preparation and/or review of Risk management documents including risk management plans, risk matrix status reports, PPMRR, etc. PMS and RM input into Product Development Represent PMS interests in multi-disciplinary teams during product development. Assures development and completion of PMS deliverables throughout the design process. Provides input of PMS related product risk & quality issues during the development of new products. You're the right fit if: You have a minimum of Bachelor's degree in Life Sciences, Biomedical Engineering, or a related technical field. You have 4-8 years experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment - Mandatory You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc - Mandatory You have excellent communication (written and oral) and stakeholder management skills, with the ability to influence at all levels. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, quality and compliance. Product Knowledge on Diagnostic X-rays is preferred. In return, we offer you At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services. How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillance Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc. Your role: You are responsible for managing activities related to post-market product safety surveillance and risk management. Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E). Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics. Post Market Surveillance (PMS) Ensures standard PMS processes across business unit is established Assures consistent PMS plans exists for all products Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions). Assures consistent PMS Reports/PSURs for all products. Conduct periodic quality board meeting to review PMS data collected according to the PMS plan and take appropriate actions as necessary to ensure the product remains safe and compliant. support Complaint trending investigation, signal assessment & escalation Assesses significant triggers & safety concerns during periodic quality review meeting and assures standard approach for signal disposition incorporate findings in PMS reports and trigger risk management file update, as required. Patient Safety and Regulatory Reporting In collaboration with Data trending and analytics and Medical Affairs, monitors and assesses safety signals, and recommends actions. Support in assessment of product relationship to reported complaint Assures standard regulatory reporting assessment criteria for PMS activities Provides input to clinical conclusion to be included in the reports to competent authorities. Enable correction & removal decision making by facilitating on time and accurate post market risk assessments. Risk Management Support standard Risk Management processes Facilitate post-market risk assessments including issue impact assessment, health hazard evaluations. Collaborate with cross-functional stakeholders including R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc. to drive meaningful post market risk assessment of issues. Support the preparation and/or review of Risk management documents including risk management plans, risk matrix status reports, PPMRR, etc. PMS and RM input into Product Development Represent PMS interests in multi-disciplinary teams during product development. Assures development and completion of PMS deliverables throughout the design process. Provides input of PMS related product risk & quality issues during the development of new products. You're the right fit if: You have a minimum of Bachelor's degree in Life Sciences, Biomedical Engineering, or a related technical field. You have 4-8 years experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment - Mandatory You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc - Mandatory You have excellent communication (written and oral) and stakeholder management skills, with the ability to influence at all levels. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, quality and compliance. Product Knowledge on Diagnostic X-rays is preferred. In return, we offer you At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services. How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillance Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc. Your role: You are responsible for managing activities related to post-market product safety surveillance and risk management. Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E). Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics. Post Market Surveillance (PMS) Ensures standard PMS processes across business unit is established Assures consistent PMS plans exists for all products Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions). Assures consistent PMS Reports/PSURs for all products. Conduct periodic quality board meeting to review PMS data collected according to the PMS plan and take appropriate actions as necessary to ensure the product remains safe and compliant. support Complaint trending investigation, signal assessment & escalation Assesses significant triggers & safety concerns during periodic quality review meeting and assures standard approach for signal disposition incorporate findings in PMS reports and trigger risk management file update, as required. Patient Safety and Regulatory Reporting In collaboration with Data trending and analytics and Medical Affairs, monitors and assesses safety signals, and recommends actions. Support in assessment of product relationship to reported complaint Assures standard regulatory reporting assessment criteria for PMS activities Provides input to clinical conclusion to be included in the reports to competent authorities. Enable correction & removal decision making by facilitating on time and accurate post market risk assessments. Risk Management Support standard Risk Management processes Facilitate post-market risk assessments including issue impact assessment, health hazard evaluations. Collaborate with cross-functional stakeholders including R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc. to drive meaningful post market risk assessment of issues. Support the preparation and/or review of Risk management documents including risk management plans, risk matrix status reports, PPMRR, etc. PMS and RM input into Product Development Represent PMS interests in multi-disciplinary teams during product development. Assures development and completion of PMS deliverables throughout the design process. Provides input of PMS related product risk & quality issues during the development of new products. You're the right fit if: You have a minimum of Bachelor's degree in Life Sciences, Biomedical Engineering, or a related technical field. You have 4-8 years experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment - Mandatory You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc - Mandatory You have excellent communication (written and oral) and stakeholder management skills, with the ability to influence at all levels. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, quality and compliance. Product Knowledge on Diagnostic X-rays is preferred. In return, we offer you At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services. How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

As a PSUR Specialist, your primary responsibility will be to author and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities. You will play a crucial role in ensuring the accuracy, completeness, and regulatory compliance of all PSURs. Additionally, you will be tasked with performing literature searches to gather relevant data for PSUR preparation and validating the information obtained to ensure accuracy. Your role will involve extracting and validating data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). You will also be responsible for generating Line Listings (LL) from the safety database for inclusion in PSURs. Effective process management is key, as you will need to manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Providing reliable support for high-priority ad-hoc activities related to PSUR preparation will also be part of your daily tasks. Client interaction is an important aspect of this role, as you will communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies. It will be your responsibility to ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines. Furthermore, you will serve as a subject matter expert (SME) for PSUR preparation and review, providing training and mentoring to team members on PSUR-related processes and regulatory requirements. To excel in this role, you should hold a Bachelor's degree in a relevant scientific or medical field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review, is essential. Knowledge of regulatory requirements for PSURs/PBRERs, strong analytical and problem-solving skills, excellent written and verbal communication skills, proficiency in safety databases and data extraction/validation processes, as well as strong organizational skills are key qualifications needed for this position. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert support will be critical for success in this role.,

We are looking for MBBS - Medical Reviewer with 2-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain procedures for medical review activities (ICSRs, aggregate reports and signal management). Ensure high quality of ICSR, aggregate and signal management deliverables. Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management plans, and signal reports. Participate in/organize review of safety label updates. Mentor and train medical reviewers. Provide product and therapeutic area trainings for the PV team. Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members. Behavioral Competencies Excellent interpersonal communication and writing skills with experience handling cross-functional projects Good conflict resolution skills Ability to work in a multi-cultural/global work environment Good mentoring skill

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and completeness of reports. - Continuous process improvement in the team for developing content. - Participate in assigned training programs and create training materials and guidelines. - Interface with clients regularly to meet their expectations. **Qualifications:** - Medical/M.Pharm/Pharm D/life sciences degree. - Minimum 4 years of experience in medical writing or equivalent life sciences domain experience. - Knowledge of regulatory documentation, drug development process, and global regulations. - Excellent written and verbal communication skills, organizational and time management skills, and strong data interpretation and presentation skills. - Strong interpersonal skills and the ability to be flexible in varying environments. Indegene is proud to be an Equal Employment Employer committed to Inclusion and Diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions will be based on business requirements, the candidate’s merit, and qualifications. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to any protected characteristics. Thank you for your attention to this matter. We look forward to receiving suitable profiles from you soon.

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

Opening for Aggregate Reports , Ahmedabad Role & responsibilities : Authorising of Aggregate reports (PSUR's/PBRER's/PADER's/Annual Reports/ACO/DSUR for submission to local and other Health Authorities. RMP's Pharmacovigilance Updating/Reviewing of Pharmacovigilance system master file (PSMF). Author and review of Periodic Aggregate Safety Reports (PADERs, PSURs, DSU ensuring timely and compliant submissions to global health authorities. Interested candidates shared resume on snehal@topgearconsultants.com