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 surveillanc...

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 surveillanc...

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 surveillanc...

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 t...

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 rev...

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 comp...

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 a...

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