4 Psurs Jobs

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.