1729 Pharmacovigilance Jobs - Page 5

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. The Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to ProPharma clients. Essential Functions: Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications. Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Compiles regulatory documents / reports, gathering all required documents, within all established timelines. Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks. Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable. Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions. Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues. Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity. Performs peer / quality review of documents processed by other team members as requested. Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing. Brings issues and potential concerns to line manager / client oversight manager s attention in a timely manner. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). May occasionally be required to work outside of normal business hours to support client s needs. Other duties as assigned. Necessary Skills and Abilities: Extensive knowledge and mastery of Microsoft Word (advanced level formatting). Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier). Excellent problem-solving skills, including the ability to think outside the box. Ability to work on multiple projects at a time. Exceptional project management and communication skills with a high attention to detail and quality. English language proficiency. Ability to think proactively and take initiative, with a willingness to take on new challenges. Ability to work independently and contact management team proactively when additional support and resources are needed. Ability to work effectively in a collaborative team environment. Ability to work within established working hours. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements: Bachelor s degree, preferably in life sciences (or related field). Experience Requirements: Minimum 3 years of experience in document publishing and / or formatting. Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred. Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

MISSION: The Case Specialist s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business. Main activities and technical skills: VIGILANCE CASES: Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other). Seriousness of the events/effects/incidents . Expectedness/listedness. Data entry of vigilance cases in ad hoc databases or in formats defined with the client. Follow-up request of vigilance cases by phone/mail Suggesting queries to complete the case. Confirm or support Data Officers submission requirements. Validation of documents within the Safety and Vigilance platform. Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download. Reconciliation activities. MEDICAL INFORMATION: In support of the medical information line of Business Taking phone calls reporting vigilance notifications. CUSTOMER/PROCESS MONITORING: Participation in the operational implementation of new clients. Key contact with clients (with the support of a senior member of staff or the division manager). Drafting/updating of technical agreements /safety management plan / client template (for a trial for example) Drafting/updating of procedures/ operating methods or others directly related to its activity Participation in the implementation/ maintenance/ improvement of processes Additional Activities: Participation in the coordination of Case Management by relaying to the coordinator if necessary. Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines. Required Education: BPharm / MPharm Required Experience: 4-5 years Required Technical Skills: Well versed with MS Office, Safety Databasea Additional Skills & Experience: Presentation skills, Communication Skills, Should be well versed with pharmacovigilance basics, case processing and associated conventions, thorough knowledge of GVP modules, ICH guidelines, regulatory requirements, MedDRA coding, well versed with safety databases, solution oriented.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Lead triage and resolution of incidents within Safety ecosystem (e.g., Argus, LSMV, Aris G). Independently resolve recurring and complex L1/L2 issues Perform in-depth troubleshooting and guide resolution of recurring issues. Act as the first point of contact for major incidents or outages. Identify patterns from recurring tickets and initiate corrective actions. Work with platform teams to implement automation, monitoring, and process improvements. Mentor junior support engineers and lead knowledge-sharing sessions. Develop and maintain SOPs, troubleshooting scripts, and process checklists. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master's degree / Bachelor's degree and 5 to 9 years of experience in Computer Science, IT or related field Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Hands on experience ITSM tools like Service now or JIRA Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc.) Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e.g., MuleSoft). Experience with cloud-based technologies and modern data architectures. Knowledge of automation tools or scripting (e.g., Python, PowerShell) for diagnostics. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Position overview: We are seeking a highly motivated healthcare graduate passionate about infectious diseases and public health as a Management Trainee. In this role, you will work closely with the Medial affairs team to support the development, implementation and evaluation of clinical initiatives, antimicrobial stewardship interventions, and other digital initiatives. This role is ideal for recent graduates in medicine, pharmacy, or life sciences with a strong interest in clinical strategy, infectious diseases, or public health. Responsibilities: Assist in planning and executing Orchid AMS clinical initiatives, including pilot programs, training workshops, and collaborative interventions. Support data collection, organization, and analysis of clinical and microbiological datasets to understand real-world practices and aid strategic decision-making. Contribute to monitoring antimicrobial utilization and resistance trends using established tools and methodologies. Participate in literature reviews and assist in developing scientific content such as slide decks, abstracts, white papers, SOPs, and case studies, under guidance. Generate insights from data to support antimicrobial stewardship interventions, performance benchmarking, and outcome reporting. Assist in documenting and communicating stewardship outcomes through reports and presentations, ensuring adherence to internal SOPs and quality standards. Liaise with internal stakeholders (Medical Affairs, Marketing, Sales, etc.) to support cross-functional initiatives and ensure effective information flow. Contribute to continuous improvement of processes by providing feedback and supporting implementation efforts. Qualifications: MPharm/PharmD degree. 0-2 years of work experience Essential: Sound understanding of pharmaceuticals and their clinical applications. Analytical mindset with strong data analysis and visualization skills. Proficiency with tools Like MS office, Tableau, PowerBI. Excellent written and verbal communication skills. Desirable: Flair for solving current healthcare challenges in healthcare settings. Prior exposure to hospital settings and understanding of clinical workflow. Prior involvement in QI projects, AMR data analysis, or stewardship activities. Benefits: Opportunities for career growth and development. Collaborative and Innovative work environment. Positive company culture focused on improving patient care.

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality. Process: 1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About you Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills : As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-ver sed with computer applications ) Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent English language knowledge (to read, write and speak)

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Monitor, solve, and resolve issues related to adverse event data processing across the safety ecosystem. Triage and conduct detailed investigations into system disruptions, data anomalies, or processing delays to determine and nature and scope of the problem Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues and triage the issues and provide L1/L2 support Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 2 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc.) Basic familiarity with ITSM tools like Service now or JIRA Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e.g., MuleSoft). Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Help us transform and bring innovation to Drug Safety and Pharmacovigilance! Veeva is looking for Drug Safety and Pharmacovigilance experts to join the Professional Services team and support implementations of our Vault Safety solution. We want innovative thinkers with deep domain expertise who are ready to challenge the status quo with new technology. As a key member of our Professional Services team, the Consultant - Safety will work side-by-side with customers and our senior consultants and solution Architects to implement Vault Safety. In this role, the candidate will support the overall delivery of Vault Safety for our customers. They will define and drive business processes, support the project team in delivering the solution, and guide our customers throughout the implementation programs. What You’ll Do Support life sciences customers in the rapid configuration and implementation of Vault Safety. Execute workshops and lead customer discussions of the Vault Development Cloud. Lead gap analyses, workshop preparation and delivery, requirements gathering, configuration, validation, and customer training. Gather customer functional and technical requirements to support business processes; translate requirements into system configuration. Provide subject matter expertise on Drug Safety and Pharmacovigilance for customers and project teams. Represent Safety Professional Services across multiple engagements and workstreams (e.g. solution design and configuration, data migration, systems integration, etc.). Ensure customer success from beginning to end of the engagement life cycle. Provide Argus / Aris data model expertise in migrating customers’ existing data into Vault safety. Requirements 3+ years of life sciences industry experience, with the majority of time spent in the Drug Safety and Pharmacovigilance domain and experience in a consulting function. Knowledge of Drug Safety and Pharmacovigilance processes and regulations. Must have decent experience writing complex SQL queries on safety data sets. Should have worked on implementing safety systems like Aris / Argus / Emperica / Commonwealth / RxLogix / or any homegrown safety system Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction. Good to have experience building aggregate and analytical reports on safety data set. Strong English communication skills, both written and verbal. Must have worked in an individual contributor capacity in previous employment. Ability to act with speed to understand business requirements, create corresponding solution designs, and willingness to “roll up your sleeves” to design and deliver Vault Safety. Exposure to life sciences compliance and computer systems validation requirements. Ability to travel for about : 25% of the project time. Bachelor’s degree or equivalent required. Has the right attitude and mindset to work towards customer success. Nice to Have Proven track record supporting high-impact global system implementation programs as a consultant, business or IT lead, and/or business sponsor. Direct experience with Argus and/or other drug safety applications Life science, computer science, or related degree SaaS/Cloud experience Experience in service delivery management and/or systems implementation Locality to major life sciences customer hub (Bangalore, IN; Hyderabad, IN) Perks & Benefits Health Insurance fully covers the family, including Employee’s parents Work from anywhere culture which allows flexible work location Fitness benefits fully taken care by Veeva Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Job Description / Capsule Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of AstraZeneca medicines. Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco- economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Scientific Expertise Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca’s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical. Customer Insight: Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Essential Education, Qualifications, Skills and Experience Scientific and or a master’s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Date Posted 26-Jun-2025 Closing Date 30-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

We are Hiring for “Diabetes Educator “ !!!! Company Name: Kartavya Healtheon Pvt Ltd. Website: http://kartavyahealtheon.com Location -Nellore Contact Number: +91 77009 05394 Experience: -01 - 03 Yrs. Company Overview: Kartavya Healtheon is a Mumbai-based B2B healthcare company that drives patient engagement models. Our services include organizing in-clinic camps, running patient support programs, and operating specialty pharmacy services. Our mission is to make healthcare accessible to everyone, regardless of their location. We are currently running a program on behalf of one of our pharma clients to provide diabetes education and support to patients. As part of this program, we are looking for a skilled and compassionate Diabetes Educator to join our team. Job Overview : The Diabetes Educator will be responsible for educating patients with diabetes on how to manage their condition effectively. The Diabetes Educator will be responsible for Set of Doctors' clinics and hospitals handle OPD to provide patient education, counselling, queries resolution, program enrolment, pen demonstration, and guiding patients to the nearest pen station. The ideal candidate will have excellent communication and interpersonal skills, be able to work independently, and have a passion for helping patients with diabetes manage their condition. Responsibilities: Handle Set of Doctors' OPD clinics and hospitals to provide patient education, counselling, and support for diabetes management. Conduct pen demonstrations for patients. Develop a rapport with patients by responding to their queries and concerns. Guide patients to the approved pen stations. Follow up with patients to check on therapy initiation and support them in resolving any challenges. Enrol patients into the program by capturing patient details in the CRM system. Maintain a database of patients to ensure timely follow-up and support. Organize camps and patient support initiatives with doctors. Report on pharmacovigilance and implementation of compliance guidelines to ensure patient safety. Provide feedback to the Reporting Manager. Requirements: Science graduate or qualified dietician with 1 to 2 years of experience in Pharma or allied services or diet counselling or certified diabetic educator. Passion for working in the field and helping patients manage their diabetes. Excellent communication and interpersonal skills Ability to work independently and manage time effectively Ability to work flexible hours, including evenings and weekends if required Willingness to learn and a positive attitude with a pleasing personality Working Conditions: The Diabetes Educator will work in a variety of settings, including doctors' clinics and hospitals. They must be able to work flexible hours, including weekends and holidays. Note: The Diabetes Educator position is being offered as part of a program on behalf of one of our pharma clients, and the selected candidate will be hired by our company. Thanks & Regards,

As a Pharmacovigilance Services Associate at Accenture, you will play a crucial role in Pharmacovigilance Operations, focusing on Drug Safety Surveillance. You should hold a Bachelor of Pharmacy or Master of Pharmacy degree and have 1 to 3 years of relevant experience. Accenture is a global professional services company known for its expertise in digital, cloud, and security solutions. With a workforce of 699,000 individuals across 120 countries, we specialize in Strategy and Consulting, Technology, and Operations services. At Accenture, we leverage technology and human ingenuity to drive value and success for our clients, shareholders, partners, and communities. In this role, you will be part of the Life Sciences R&D vertical, supporting services that cover the entire life sciences landscape. From research laboratories to clinical trials support and regulatory services, your responsibilities will include pharmacovigilance and patient services solutions. You will collaborate with leading biopharma companies to bring their visions to life and enhance patient outcomes by integrating scientific expertise with insights into the patient experience. Your primary responsibilities will involve managing the Affiliate Mailbox, reconciling reports, and following up on Serious and Non-serious cases. You will be tasked with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in compliance with client guidelines and global regulatory requirements. As a Drug Safety Associate, you will be expected to solve routine problems using general guidelines and referrals, with interactions primarily within your team and direct supervisor. You will receive detailed instructions for daily tasks and new assignments, and your decisions will directly impact your work. Working as an individual contributor within a focused team, you may be required to work in rotational shifts. If you are passionate about pharmacovigilance operations, drug safety surveillance, and making a positive impact in the life sciences industry, this role at Accenture offers an exciting opportunity to contribute to cutting-edge solutions that improve patient outcomes and drive innovation.,

The Affiliate Safety Representative (ASR) in India plays a crucial role in ensuring that all activities related to pharmacovigilance (PV) for Abbott EPD investigational and registered medicinal products under Abbott India Limited (AIL) and Abbott Healthcare Pvt Ltd (AHPL) are conducted in compliance with internal Abbott policies, procedures, and local regulatory requirements. The ASR is also responsible for overseeing PV activities in neighboring countries such as Nepal, Bhutan, Maldives, and Sri Lanka. Additionally, the ASR serves as the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization. Key responsibilities of the ASR include: - Acting as the Pharmacovigilance Officer In-Charge (PvOI) on a 24/7/365 basis - Maintaining the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates - Conducting PV business continuity planning and notifying any business interruptions that may impact pharmacovigilance processes or regulatory compliance - Receiving, recording, and reconciling safety information - Conducting safety surveillance, including literature and health authority website screening, and preparing local periodic safety reports and Risk Management Plans - Submitting safety information to regulatory authorities - Providing basic PV training to local EPD staff - Managing PV records retention and archiving - Implementing out-of-office coverage for receiving and recording safety-relevant information - Maintaining the local PV product list - Ensuring PV compliance in local interventional studies and data collection schemes - Negotiating and implementing local pharmacovigilance agreements - Conducting due diligence for product acquisition or in-licensing - Providing local PV Compliance metrics and managing non-compliances - Coordinating PV audits and inspections at the Affiliate level - Ensuring vigilance compliance for various Abbott EPD products - Supporting in the preparation of Health Hazard Assessment/Medical Expert Statements - Acting as a Marshal for PV Self-Assessment Work Instruction and PV Representative for Global Clinical Programs - Reviewing and approving local PV training matrices - Collaborating with stakeholders to exchange PV-relevant information - Handling global projects The ASR is responsible for managing a team of direct reports and is accountable for the implementation and maintenance of a functional and compliant local PV system. The role requires expertise in PV, understanding of local PV regulations, attention to detail, computer literacy, strong English language skills, and effective communication and presentation abilities. Minimum qualifications for the role include: - 10+ years of PV experience in a pharmaceutical company - Understanding of local PV regulations - Attention to detail - Computer literacy (Windows, MS Office) - Good English language skills - Strong communication and presentation skills with internal and external stakeholders Ideally, candidates should hold a graduate degree in Medicine, Pharmacy, or equivalent qualification.,

About The Job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality. Process: 1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About You Experience: >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills: As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages: Excellent English language knowledge (to read, write and speak) null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

We're Hiring: Senior Business Development Specialist Location: Kukatpally, Hyderabad | Onsite Experience: 3+ Years Medifodil Smart Pharma Solutions is looking for a dynamic and results-driven Senior Business Development Specialist to join our growing team! We are a healthcare services company offering end-to-end solutions in: ✔️ Pharmacovigilance ✔️ Clinical Trials ✔️ Regulatory Affairs If you have a passion for identifying new business opportunities and building lasting client relationships in the pharma and life sciences domain, we’d love to connect with you. -Key Responsibilities: Drive B2B sales and strategic partnerships in pharmacovigilance, clinical research, and regulatory domains Identify, pitch, and close deals with pharma and biotech clients (domestic & international) Conduct regular follow-ups and client meetings to maintain long-term relationships Collaborate with internal teams to customize service offerings based on client needs Monitor market trends and competitor activity to identify new opportunities Represent the company at conferences, industry events, and networking meets Requirements: -Who we are looking 3+ years of experience in business development, preferably in pharmacovigilance or clinical research services Strong understanding of pharma outsourcing models and CRO services Excellent communication, negotiation, and interpersonal skills Proactive, target-oriented mindset Join us in transforming pharma support services with purpose and precision. 📩 To apply, send your resume to contact@medifodil.com or DM me directly.

At Bayer we re visionaries, driven to solve the world s toughest challenges and striving for a world where ,Health for all, Hunger for none is no longer a dream, but a real possibility. We re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible . There are so many reasons to join us. If you re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there s only one choice. Sr Medical Advisor - Oncology POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with TLs. YOUR TASKS AND RESPONSIBILITIES : Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors Support and educate internal customers in compliance with the Country s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Senior Medical Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programmes of the Business units within portfolio (included local studies NIS, IIR). Identifies, initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, collaborative and customer focused. Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel Ever feel burnt out by bureaucracy? Us too. Thats why were changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https: / / www.bayer.com / enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us + 022-25311234

About the job Use Your Power for Purpose At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Organizational Relationship(s) including to whom the position reports to: Case Processing Team Lead Position Purpose Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s products and to meet regulatory requirements. Primary Responsibilities Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative. Generate reports, ensuring adherence to regulatory compliance timelines. Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pfizer policies. Qualifications (i. e. , Preferred Education, Experience, Attributes) Minimum a bachelor s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc). 1 3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE

JD: Serve as the company s subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.) Mentor and develop PV team members to maintain a culture of continuous improvement and compliance Manage departmental budgets, staffing, and resourcing in line with organizational needs Qualifications: Advanced degree in Medicine or Pharmacy Minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry In-depth understanding of Local/global PV regulations and guidance Demonstrated experience in leadership roles with proven ability to build and scale PV systems. Strong analytical, strategic thinking, and communication skills. JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 4 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 4 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 2 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 2 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

The candidate must possess in-depth functional knowledge of the process area and apply it to operational scenarios to provide effective solutions. The candidate must be able to identify discrepancies and propose optimal solutions by using a logical, systematic, and sequential methodology. It is vital to be open-minded towards inputs and views from team members and to effectively lead, control, and motivate groups towards company objects. Additionally, the candidate must be self-directed, proactive, and seize every opportunity to meet internal and external customer needs and achieve customer satisfaction by effectively auditing processes, implementing best practices and process improvements, and utilizing the frameworks and tools available. Goals and thoughts must be clearly and concisely articulated and conveyed, verbally and in writing, to clients, colleagues, subordinates, and supervisors. Associate Process Manager Role and responsibilities: Process and monitor incoming payments and outgoing invoices. Reconcile accounts payable and receivable balances on a regular basis. Manage and maintain accurate records of all financial transactions. Resolve any billing discrepancies and respond to vendor inquiries. Prepare and process electronic transfers and payments. Assist with monthly, quarterly, and annual financial reporting and audits. Maintain vendor files and ensure all documentation is up to date. Coordinate with internal departments to ensure efficient invoicing and payment processes. Qualifications Bachelors degree in Finance, Accounting, or related field. 4+ years of experience in accounts payable and/or receivable. Strong knowledge of basic accounting principles and financial regulations.

JOB PROFILE General Job Title: Associate I Job Grade: JL-7 (Medical Safety 7.01) Department: Product Quality Surveillance & Customer Affairs Reports to (Name & Job Title): Manager I Global Device Vigilance Job Purpose (State in one sentence the overall objective of the job) The role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives. This role may be required to work in shifts. Major Accountabilities (Describe the main results of the job to be achieved) Case Processing: Process case files according to Standard Operating Procedures (SOP). Work with affiliate offices to ensure required dataset has been received/requested. Re-assess the data, ensure accurate product selection and assign required event code(s) in the system. Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings). Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries Launch required quality investigation records. Schedule expedited and periodic regulatory reports based on local and international reporting regulations. Perform and receive quality feedback on case management and coding. Adherence to all corporate compliance guidelines & corporate programs. Maintains a working knowledge of the following: Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials) Eye anatomy Common diseases Ophthalmic evaluation procedures Eye terminology and abbreviations Safety database(s) and reporting tools Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs) Provide support in reconciliation activities and audit as required. Evaluate and escalate potential safety issues to management. Role Dimensions: Number of associates: None Financial responsibility: None Impact on the organization: Low Key Performance Indicators (Indicate how performance will be measured: indicators, activities…) KPIs will be outlined in detail in the goal sheet, and will largely be around below parameters: Meets internal and external quality standards Review and close files within prescribed timelines Creates high quality regulatory reports for submission on or before assigned due dates Ideal Background (State the minimum and desirable education and experience level) Education Minimum: Graduation in Science Desirable: Graduation in Optometry/ Pharmacy/M. Pharm/B. Pharm /BDS/BAMS/BHMS/ Biomedical Engineering / Registered Nurse Experience requirement: Minimum: Healthcare professional with 1-2 years of experience Desirable: Experience in Device Vigilance / Pharmacovigilance / Regulatory Submissions / Clinical Research / PVPI/ Medical Coding Languages: Minimum: English (written and spoken) Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements Excellent listening ability and communication skills Excellent decision quality and negotiation skills Ability to manage multiple tasks, attention to detail, prioritize work and manage time well Knowledge and understanding of national and international medical device regulations and regulatory guidelines Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice Basic knowledge of MS Office Associate Name SAP ID Signature Date HR SPOC ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Job Title: Trainee Pharmacist Company Name: DM Hospital Job Description: As a Trainee Pharmacist at DM Hospital, you will be an integral part of the pharmacy team, assisting in the provision of high-quality pharmaceutical care to patients. You will work under the supervision of licensed pharmacists, gaining hands-on experience in medication management, patient counseling, and pharmacy operations. Your responsibilities will include preparing and dispensing medications, conducting medication therapy management, ensuring compliance with regulatory standards, and providing support in pharmaceutical services to enhance patient health outcomes. Key Responsibilities: - Assist in the preparation and dispensation of medications, including oral and intravenous formulations. - Conduct medication reviews and assist in monitoring patient medication therapy. - Provide accurate drug information to healthcare professionals and patients. - Participate in inventory management, including stock checks and ordering of pharmaceuticals. - Support the pharmacist in counseling patients about their medications, including dosage, side effects, and interactions. - Maintain accurate records and documentation of all pharmaceutical activities. - Collaborate with healthcare team members to ensure continuity of care for patients. - Uphold compliance with laws, regulations, and standards governing pharmacy practice. Skills and Tools Required: - Strong understanding of pharmacology, pharmacy law, and medication management. - Excellent communication and interpersonal skills for effective patient interaction. - Detail-oriented with strong organizational skills to manage multiple tasks. - Ability to work collaboratively in a team environment and assist in crisis situations. - Proficient in using pharmacy management software and electronic health record systems. - Basic knowledge of medical terminologies and drug classifications. - Ability to handle and resolve conflicts in a professional manner. - Willingness to learn and adapt to new challenges in a dynamic healthcare setting. - Strong commitment to patient safety and quality of care. Qualifications: - Bachelor’s degree in Pharmacy or currently enrolled in a Doctor of Pharmacy (Pharm.D) program. - Demonstrated interest in pursuing a career in hospital pharmacy. - Previous internship or experience in a pharmacy setting is a plus but not required. - Active registration as a pharmacy student or intern under the relevant pharmacy board (if applicable). Roles and Responsibilities About the Role: - As a Trainee Pharmacist at DM Hospital, you will gain hands-on experience in pharmaceutical care. - You will work under the supervision of licensed pharmacists to support medication management and patient safety. - The role involves assisting in dispensing medications and providing patient counseling on drug therapies. About the Team: - You will be part of a multidisciplinary healthcare team dedicated to improving patient outcomes. - The pharmacy team collaborates closely with doctors, nurses, and other healthcare professionals to ensure comprehensive care. - Team members are committed to ongoing education and professional development, fostering a supportive learning environment. You are Responsible for: - Assisting pharmacists in preparing and dispensing medications accurately. - Conducting medication reconciliation and ensuring patient records are up-to-date. - Providing information and guidance to patients regarding their medications and potential side effects. To succeed in this role – you should have the following: - A genuine interest in pharmacy practice and patient care. - Strong attention to detail and excellent communication skills. - A willingness to learn and adapt in a fast-paced healthcare setting.

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Summary This position is a member of Global Patient Safety Data Management team. The Safety Data Analyst I is responsible for performing searches in the database and generating complete and accurate reports for internal and external customers, including regulatory authorities. In addition, the Safety Data Analyst is also responsible for ensuring that information entered and retrieved from the databases is consistent and accurate and is also involved in developing and testing new report formats. Responsibilities The responsibilities include, but are not limited to the following: Generate complete and accurate periodic reports and ad-hoc reports from the Pharmacovigilance database Develop and standardize SQL queries to ensure consistency of reports generated Collaborate with the report requestor to assure accurate interpretation of the data request Ensure timely completion and distribution of reports and query requests Serve as a data integrity escalation contact for downstream users of Pharmacovigilance data (Safety Writers, Drug Safety Physicians, Risk Management, Epidemiology, etc.) Ensure consistent interpretation of system related conventions, specifications, and definitions between IT and GPS functional areas Collaborate with Safety Systems Analysts and IT to plan and implement system related improvements regarding queries and report generation. Support may include planning, testing, piloting. Participates in developing new report formats using Business Intelligence Tools Take initiative to recognize, prioritize & escalate potential safety/compliance issues Identify and troubleshoot root causes of thematic data integrity issues Identify potential errors and omitted data found during query and address them for review to the responsible user Interface and collaborate within the scope of these responsibilities with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety info other functions within Pharmacovigilance in all aspects of data management with other Baxter groups (e.g. Clinical and Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc.). Qualifications, education and experience Bachelor's degree in computer science, life-science or scientific discipline or equivalent Previous experience in performing database searches and creating reports out of a database One year of previous experience in Safety Data Management or related area is an advantage Understanding of Pharmacovigilance terminology is an advantage Good knowledge of MS Excel, solid basis of SQL knowledge Previous experience with a Business Intelligence tools (e.g. Business Objects) is an advantage Solid understanding of database model, ideally of a Pharmacovigilance database experience with ARISg is an advantage Technical, analytical and problem solving skills in regards to data and queries Strong organizational skills with strong attention to detail Excellent written and oral communication skills Operates effectively in a team environment Ability to work under tight timelines Strong organizational skills with attention to detail Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

About the Role The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers – both internal and external - and generating and communicating relevant, meaningful, and impactful data. What You’ll Do: Draft/Review of Periodic Safety Update Reports and Periodic Adverse Drug Experience Reports from a medical standpoint. To prepare Signal reports (including DSR, DEP, SAR as applicable) and managing the compliance and quality of signal detection. Medical writing to support product safety reviews and clinical evaluations. Support if required to draft/review ad hoc safety reports like RMP, CES, HA response in stipulated time frame. Contribute towards continued improvement of safety systems and processes. Oversight of safety related variations and maintenance of product information. Keep abreast of changing PV requirements across Europe and Rest of World. Represent the company during Scientific meetings and Audits and Inspections. Compliance with GPvP requirements, demonstrated through audits and inspections. Support to the business and provision of documentation within agreed timeframes. Successful relationships with all external partners. Address internal and external inspection findings. Ensure all documentation is structured and maintained as required Ensure PV systems are in line with industry standards. Interaction with Regulators, patients and prescribers from a safety perspective if required. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives. For this role, you will also have the following: Qualifications: Tertiary qualification in any discipline within Life sciences or Pharmacy. Post-graduate qualification (e.g. Masters) in an industry relevant field. Knowledge, Skills & Experience: Must have significant experience in Drug safety or Pharmacovigilance in a pharmaceutical company. Proven ability to analyze scientific data. Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers). Experience in Compliance tracking (e.g. PSMF, safety databases) and Pharmacovigilance Audits. Open and adaptable to challenging environments. Ability to work with different Global culture and different time zones. Excellent attention to detail and innovative solution finding ability. Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others. A positive and ‘can-do’ approach, biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Job Overview Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Essential Functions Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan. Perform activities related to adjudication as applicable Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting. Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Ensure to meet quality, productivity and delivery standards per project requirements. Ensure compliance to all project related processes and activities. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed. Provide and impart technical and process information to Safety Management and members of operational team on project specific issues. Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives. Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement. Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes effective feedback on project performance to junior members of team. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts. Participate or Lead trainings across Safety process service offerings participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. To liaise with client in relation to details on day to day activities as needed. Contribute to achievement of departmental goals Perform other duties as assigned 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Excellent knowledge of medical terminology. Intermediate In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced maintain high quality standards. Advanced Excellent working knowledge of Microsoft Office and web-based applications. Intermediate To demonstrate effective project management and leadership skills. Intermediate Effective mentoring and coaching skills. Advanced Excellent verbal/written communication skills. Advanced Self-motivated, flexible, receptive to changing process demands. Advanced willingness and aptitude to learn new skills across Safety service lines. Advanced Proven ability to work independently and autonomously with policies and practices. Advanced Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced Ability to identify, prioritize tasks and delegate to team members. Advanced Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced Demonstrate Sound judgment and decision making skills. Advanced Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities. Intermediate Ensure quality of deliverables according to the agreed terms. Advanced Demonstration of IQVIA core values while doing daily tasks. Advanced Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate Support audit preparedness Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Advanced IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

The PV Scientist Manager is responsible for the following: Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports Works with affiliates and other internal Amgen partners regarding deliverables Review of AE/SAEs from clinical trials as needed Contributes under the direction of the Global PV Sr. Scientist or Lead to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO Prepare safety assessment reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Participates in Safety Governance per Amgen processes Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body Assist GSOs and other Senior Scientists in the development of risk management strategy and activities Provides contents for risk management plans Update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility The PV Scientist contributes to GPS in the following ways: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Participates on teams for the implementation of new processes and methods within the Therapeutic Area Basic Qualifications and Experience: Master’s or Bachelor's degree with minimum 9+ years of experience in relevant fields.