1722 Pharmacovigilance Jobs - Page 2

Description Safety & PV Specialist I (Review of literature cases) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information. Skilled in extracting and summarizing key safety information from identified literature sources Thorough understanding of creating and validating search strategies for pharmacovigilance purpose. In depth knowledge of major literature databases such as Embase, PubMed etc. Experience in conducting local literature searches and reviews. Understanding of regulatory requirements with respect to global and local literature. Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualification Requirements Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet. Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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 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: Global Regulatory, RWE & Medical (2RM) Quality Operations Manager Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Our Team Opella Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patients safety. Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements. Main Responsibilities Of The Mission The purpose of the Global Regulatory, RWE & Medical (2RM) Quality Operations Managers is to support the Global Regulatory, RWE and Medical teams and implement & maintain the Quality Systems to ensure that activities ares conducted and data are generated, documented (recorded), and reported in compliance with the GxP requirements. Execute Global Quality Systems Operations for Global Regulatory, RWE & Medical (2RM) regulated activities Event & CAPA : perform QA assessment, check root cause analysis, investigation report review CAPA and approve closure secure timely closure of investigations and CAPAs escalate risk as required to 2RM Lead and to manager Change control : Create Change Control as per 2RM Quality Lead assessment coordinate until Change Control closure secure timely closure Audit & inspection operations run risk tool contribute to Global/Local audit & inspection preparedness monitor and support CAPA closure Vendors quality management: perform qualification (questionnaire, QTA…) and maintain the list of preferred vendors (G2 market excluded) Performance management : report KPI and escalate issues with remediation plan Quality document & training until Regulatory and Medical TSA exit – under the Global QD & Training head guidance – implement QD & Training management in 2RM perform Gap assessment and maintain Quality documentation Map and maintain 2RM QD packages Update and assigned local & global training curricula to global/local internal & external people Support managers in preparing on-boarding plans Manage CMS & LMS access Report QD & training KPI As the Quality Business Partner for the Global Regulatory, RWE and Medical teams: Provides Quality System expertise and support to Global Regulatory, RWE and Medical teams in the execution of Quality Systems Support Connect access management for Global Regulatory, RWE and Medical teams Manage access review Support manager in access management Elevate Quality Culture As a member of the Science Quality Operations team in Hyderabad Collaborate with other Science Quality Operations managers to standardize and continuously improve operational processes Closely interact with Quality System team and BPOs Back up other Quality Operations managers Maintain Quality processes job aids package As a member of Global Science Quality Report relevant information to prevent or revert quality crisis to Quality Lead and direct manager Manages special projects assigned by supervisor as relevant Participate to the Quality meetings as a Science Quality representative Collaborate closely with the Global Regulatory, RWE and Medical leadto ensure timely execution and full compliance in alignment with Quality strategy About You Experience : solid experience in Quality systems (5-10 years) Soft skills: client orientation, outcome obsessed, looking for simplification, assertiveness, networking capability, collaborative & team worker Technical skills: quality systems– Regulatory, RWE and Medical Education: Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields) Languages: English is compulsory (working language) - other languages welcomed Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

As a Medical Reviewing PV Author, your primary responsibility will be to review and author Clinical Comment (CCC) for case reports involving Suspected Unexpected Serious Adverse Reactions (SUSAR). You will be tasked with editing the Periodic Report Comment within the Patient Safety database, if applicable. Additionally, you will be expected to engage in activities within the Comments field of the GSP Review Workflow step in the Patient Safety database. This includes reviewing and responding to queries/comments from the Case Owner, which are documented in the Comment field of the GSP Review Workflow step. Your role as Lead Medical reviewer will require strong skills in Pharmacovigilance and ICSR. The industry type for this position is IT/Computers - Software, with a functional area focus on the Pharmaceutical sector. This is a full-time, permanent position falling under the Role Category of Life Sciences and Pharma. If you are passionate about ensuring patient safety through rigorous medical review processes and possess the necessary skills in Pharmacovigilance and ICSR, we encourage you to apply for this role. Please note the following details for the job: - Job Code: GO/JC/21470/2025 - Recruiter Name: Sangeetha We look forward to potentially welcoming you to our team as a key member in our Medical Reviewing PV Author role.,

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts, Bachelor of Pharmacy,Master of Pharmacy

Title: Senior Study Data Manager Grade: L2-1 About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Within the Clinical Trial Team (CTT), the Senior Study Data Manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. He/She is accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. He/She ensures activities are completed according to agreed standards and timelines. He/She provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Include Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data. Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates. Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution. Defining and implementing data cleaning & validation strategy integrating risk-based approaches. Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study. Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers. Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare. About You Experience: Experience on clinical data management of which, must have been in a project management role. Soft Skills:Project management skills and experience. Anticipate delivery risks. Learn and adapt quickly when facing new problems. Good interpersonal, communication, and presentation skills. Technical skills: Experience with CDM and related regulations (incl. ICH E6 and E8). Risk-based mindset focusing on Quality by Design (QbD) and on what really matters. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Join an international innovative biopharma company. Participate in the evolution of Clinical Data Management and deployment of innovations. 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.

Designation – Regional Medical Advisor / Manager Medical Liaison - Therapeutic Area Based 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. Roles & Responsibilities 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. Typical Accountabilities (Please note below are a comprehensive list of accountabilities that may require adjustment for more junior positions.) In assigned therapeutic area and geographical territory, engages in clinical and scientific exchange with medical and scientific experts, including Healthcare Professionals, and where appropriate non-traditional stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with medical objectives. 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 communication strategy. Collaborate with KEEs on study proposals (ESR or Local Study) and/or publications of interest to AstraZeneca. 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. Key Relationships to reach solutions Internal (to AZ or team) Medical Function (MA, MedEx, RA, PV, MI, NS, Dx, SMM, etc) Commercial Function (Marketing & Sales) Compliance Team External (to AZ) Healthcare professional Healthcare institution stakeholders Healthcare Ecosystem stakeholders (i.e. Research Institutions, PAYGs, Start-ups, Incubators) Service providers 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. You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates! So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours. If you’re curious to know more then please reach out to (contact person) We welcome with your application, no later than (Month) (XX) Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en If you have site, country or departmental social media then feel free to switch any of the above links. Date Posted 29-Jul-2025 Closing Date 30-Aug-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.

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time 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. Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager. Ensure to meet the expected productivity and quality standards Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences An Individual with a minimum of a Bachelor s Degree in scientific or healthcare discipline or allied life sciences graduation. Good knowledge of medical terminology. Strong verbal/written communication skills. Ability to work as a Team Player, contribute and work towards achieving Team goals. Good working knowledge of Microsoft Office and web-based applications. Self-motivated and flexible. Attention to detail and accuracy. Ability to follow instructions/guidelines, utilize initiative and work independently. Ability to manage competing priorities and deadlines. Willingness and aptitude to learn new skills across Safety service lines. Strong time management skills. Ensure quality of deliverables according to the agreed terms. Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. 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 objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e. g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e. g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref 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

Summary In line with overall product strategy, the Medical Lead is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organize clinical studies, building educational dialogue with KOLs and regulatory stakeholders About The Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s), Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way, Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions, Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities, Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines, Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others, Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements MBBS; MD Mandatory with min 2+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data & Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Ophthalmology &/or immunology Why Novartis: Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world How can we achieve thisWith our people It is our associates that drive us each day to reach our ambitions Be a part of this mission and join us! Learn more here: https:// novartis / about / strategy / people-and-culture Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https:// novartis /careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve, Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl india@novartis and let us know the nature of your request and your contact information, Please include the job requisition number in your message, Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork novartis /network Why Novartis: Helping people with disease and their families takes more than innovative science It takes a community of smart, passionate people like you Collaborating, supporting and inspiring each other Combining to achieve breakthroughs that change patientslives Ready to create a brighter future togetherhttps:// novartis / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for youSign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork novartis /network Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https:// novartis /careers/benefits-rewards Show

Hiring for Healthcare authorization Need B.pharma & M.Pharma pass with 1yr exp in medical scribe, authorization, summarization Loc Gurgaon Salary upto 5.80LPA 5 Days working Rotational shift/OFF Snehal 9625998099 Lakshita 8595954721 Divya 9910810424 Required Candidate profile Candidates must have Good communication skills. Candidates must be comfortable working in any shifts.

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time 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. Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager. Ensure to meet the expected productivity and quality standards Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences An Individual with a minimum of a Bachelor s Degree in scientific or healthcare discipline or allied life sciences graduation. Good knowledge of medical terminology. Strong verbal/written communication skills. Ability to work as a Team Player, contribute and work towards achieving Team goals. Good working knowledge of Microsoft Office and web-based applications. Self-motivated and flexible. Attention to detail and accuracy. Ability to follow instructions/guidelines, utilize initiative and work independently. Ability to manage competing priorities and deadlines. Willingness and aptitude to learn new skills across Safety service lines. Strong time management skills. Ensure quality of deliverables according to the agreed terms. Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. . 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

Aster Medcity is looking for Pharmacist Pharmacy to join our dynamic team and embark on a rewarding career journey Reviewing and interpreting prescription ordersPreparing and dispensing medicationsAdvising patients on the safe and effective use of their medications, including potential side effects and interactionsMonitoring patients for adverse reactions and ensuring that any necessary changes to their medication regimen are made in a timely mannerKeeping accurate and up-to-date records of patients' medication history and any adverse reactionsCollaborating with other healthcare professionals to provide comprehensive care to patientsStaying current on developments in the field of pharmacology and medication therapy

Primary Responsibilities: To be an effective participant in Class room training and clear the training assessments with 85% quality Consistently meet the targets set for MOCK charts Eligible employee will get confirmed as Junior Coder within a max of 6 months from the Joining Punctuality, Attendance and General Adherence to company policies, procedures and practices Strives to provide ideas to constantly improve the process Ensure adherence to external and internal quality and security standards (HIPPA/ISO/ISMS) Be an effective team player Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Eligibility To apply to an internal job, employees must meet the following criteria SG 22 can apply will move laterally Performance rating in the last common review cycle of “Meets Expectations” or higher Not be on any active CAP (Corrective Action Plan) or active disciplinary action Time in Role Guidelines Should have been in your current position for a minimum of 12 months, if you have not met the recommended minimum time in role, discuss your career interest with your manager and gain alignment prior to applying. And share the alignment email with respective recruiter while applying Required Qualifications: Any degree in Life Science or Bio-Science Any degree in Pharmacy or Pharmaceutical Sciences Any degree in Nursing or Allied Health Any degree in Medicine At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone – of every race, gender, sexuality, age, location and income – deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes – an enterprise priority reflected in our mission. #NJP External Candidate Application Internal Employee Application

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelor’s degree or master’s degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone – of every race, gender, sexuality, age, location and income – deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes – an enterprise priority reflected in our mission. External Candidate Application Internal Employee Application

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

Looking for a motivated individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Provide high-quality support to internal stakeholders through effective communication and documentation. Stay updated with changes in regulations and guidelines affecting medical review processes. Participate in quality improvement initiatives to enhance the efficiency and effectiveness of medical review activities. Job Requirements Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a team environment and communicate complex information clearly. Proficiency in using electronic health records systems and other healthcare software applications. Strong organizational and time management skills with the ability to prioritize tasks and meet deadlines. Commitment to delivering high-quality results and maintaining confidentiality and professionalism. Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering exceptional care and customer satisfaction. We are an IT-enabled services company that uses technology to improve healthcare operations and outcomes.

Company Description Boston International Clini School is an international educational institution affiliated with the United Kingdom International Qualification. It offers a range of degrees including BSC, MSC, BBA, MBA, and PHD in Clinical Research. The curriculum covers a wide spectrum of topics from early drug development to phase II-III clinical trials, pharmacovigilance, and clinical data management. The school also provides expertise in pre- and post-approval services, eTMF, Medical Writing, Medical Coding, and toxicity studies. Role Description This is a full-time on-site role for an Assistant Professor located in Pune. The Assistant Professor will be responsible for delivering lectures, developing and updating course materials, and conducting research. They will also mentor students, supervise projects, and participate in academic committees. Collaborative work with faculty on curriculum development and participating in institutional advancement activities are also part of the role. Qualifications Strong background in Clinical Research and related fields Pharm D, M.Pharm, BDS Graduates

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 29-Jul-2025 Closing Date 28-Aug-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.

Total Experience 1+yrs Strong experience in data analysis, reporting, or business intelligence Extensive experience in developing pharmacovigilance reports (e.g., ICSR metrics, compliance reports) Proficiency in Power BI and/or IBM Cognos for report and dashboard development Solid understanding of SQL, Excel, and data visualization best practices Experience collaborating with cross-functional teams to define and deliver reporting requirements Familiarity with data quality assessment and report automation techniques Strong attention to detail, problem-solving mindset, and effective communication skill RESPONSIBILITIES: Design, build, and maintain pharmacovigilance reports and dashboards in compliance with industry standards Collaborate with safety and data teams to translate reporting needs into actionable insights Validate report outputs and ensure data accuracy, completeness, and compliance Perform data integrity checks and contribute to the automation of recurring reports Stay updated with pharmacovigilance trends, tools, and reporting framework Bachelor s or master s degree in computer science, Information Technology, or a related field.

Overall Mission This position typically refers to any employee within the EPD Medical organization with medical/scientific qualifications and training who provides scientific/medical support to EPD in a non-sales capacity, where the provision of such scientific/medical support includes significant contact with Abbott customers in the field. This definition is not intended to apply to those employees whose primary job function relates to the monitoring or management of clinical studies. Reporting into the Senior Manager RMA / Head RMA this position participates in the initiation, oversight and follow-up of assigned clinical studies and medical projects initiated within the EPD Medical Organization, ensuring that activities are carried out in accordance with relevant processes and procedures. The RMA interfaces with other key members of the EPD Medical Organization - for example, Medical Managers, Clinical Research Managers and Medical Advisors - relevant to the therapeutic area for which the RMA has responsibility. The RMA assists relationships and advances the scientific credibility of the Company with established and emerging Regional/National Opinion leaders, responds to requests for scientific and medical information, and provides key scientific information updates to Regional and National Opinion leaders, as appropriate. The RMA develops, and maintains, key scientific knowledge that will enable credible dissemination of scientific information and informed scientific dialogue with physicians and opinion leaders, and the development of professional working relationships. Job Responsibilities Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. Provide scientific and technical support for, and help maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest. Ideate, design, develop and deliver innovative and engaging high science activities for Physicians and Key Opinion Leaders, to help drive Therapy Shaping in the area the RMA is assigned to, in collaboration with the Medical Affairs & the Commercial team. Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic area for which the RMA carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.): all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and, I& D * SOPs. Deliver high science, unbiased and accurate scientific presentations to physicians, individually or in groups (meetings, clinical sessions, etc.), when requested. Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts – such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts. Develop awareness and understanding of competitor issues/intelligence – for example, product strategies, studies, commercial messages, positioning, etc – and communicate, where appropriate, within the Company. Continuous and consistent support to the Medical / Marketing teams in gathering Insights and feedbacks from HCPs and Patients for more impactful brand plans / New products Attend relevant Scientific Societies meetings and Conferences, and develop summaries of key messages for use within the Company – such as key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc. Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements. Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations. Ensure up to date knowledge of products uses and external data. Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest. Support in Digital engagement of HCPs & patients through specific programmes as and when required Participate along with Medical Affairs & Clinical Operations team in real world data collection programmes Technical Competencies Therapeutic Area Expertise Management Skills Communication Skills Compliance & Process Improvement Skills Problem/Conflict Solving Ability Priority Setting Relationship Building Required Core Competencies / Attributes Adaptability: Maintain effectiveness when experiencing major changes in work tasks or the work environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Consider change or new situations as opportunities for learning and growth. Persevere when encountering adversity. When confronted with a problem or crisis consider alternatives and then take timely action. Effectively prioritize work tasks. Initiative: Take prompt action to accomplish objectives; is proactive. Maintain a strong focus on internal and/or external customers. Continuously monitor relevant information, key issues and/or trends. Proactively seek feedback and adapts behavior to improve performance. Demonstrate a willingness to learn new aspects of the business. Display Ownership for end to end execution of initiatives. Innovation: Generate innovative solutions in work situations; try different and novel ways to deal with work problems and opportunities. Use best practice and benchmark data to increase organizational performance. Identify opportunities to improve efficiencies and reduce costs. Integrity: Firmly adhere to codes of conduct and ethical principles. Exhibit honesty. Present information accurately and completely. Keep commitments to work colleagues and customers. Acknowledge and respond constructively to failure and mistakes. Teamwork & Collaboration: Work effectively and cooperatively with others; establish and maintain good working relationships with internal and external partners to facilitate the accomplishment of work goals. Help others achieve shared goals. Demonstrate a willingness to listen without interrupting. Open to diverse and different ideas. Competencies ADAPTABILITY Responds to changes in the business and clinical practice within the country; considers the impact of these changes on the assigned product(s) and therapeutic area(s) and recommends ways to take advantage of new opportunities or counter threats to the business. INITIATIVE Develops awareness and understanding of competitor issues/intelligence and communicates this information, where appropriate, within the affiliate. Applies therapeutic area knowledge to recommend clinical studies and other medical projects that will strengthen the position of assigned product(s). INNOVATION Helps develop EPD strategy by identifying future opportunities for the assigned product(s) and therapeutic areas(s) and works with HQ, Area and Affiliate colleagues to take advantage of those opportunities. INTEGRITY Ensures that all activities and interactions are conducted in accordance with all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice. TEAMWORK & COLLABORATION Supports sales/marketing/internal Affiliate teams to develop their scientific and technical expertise. Participates in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts. Technical Competencies THERAPEUTIC AREA EXPERTISE Maintains an up-to-date scientific knowledge of assigned product(s) uses and key external data. Provides scientific support for, and helps maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the assigned products and areas of therapeutic responsibility. Supports sales/marketing/internal Area teams to develop their scientific and technical expertise through the delivery of scientific update presentations, and periodic training as required. Management Skills Uses resources effectively and efficiently. Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects. Maintain and operate within budget. Capable of analyzing and investigating issues and problem solving. Communication Skills Effectively practices listening skills before responding to issues. Effectively writes, presents and communicates information to internal and external clients, including divisional management. Effective negotiation skills. Compliance & Process Improvement Skills Demonstrates the ability to exercise good judgment on regulatory compliance issues. Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities. Able to insure compliance to regulations from direct reports and outside contractors (CRO). PROBLEM/CONFLICT SOLVING Able to analyze situations and conflicts without pre-judgments and assumptions Listens carefully and with an open mind Provides direct, complete, corrective and actionable feedback Reads situations quickly Settles disputes Negotiates common ground for win/win solutions PRIORITY SETTING Prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization. Quickly senses what will help or hinder accomplishing a goal Eliminates roadblocks Relationship Building Builds credible, meaningful & deep relationships with internal and external stakeholders Is sensitive towards unmet needs of internal and external customers Key Interfaces EPD medical personnel: Clinical Research Managers, Clinical Operations Managers, Medical Advisors; Medical Information team / specialists; EPD Pharmacovigilance / drug safety personnel Marketing department across therapeutic area Sales organization of the geographic area of responsibility. Administrative personnel of the Medical Department and of the Business Unit. Healthcare personnel (including; physicians, nurses, pharmacists). Patients (through Patient Awareness Programs) Participating Research Investigators Key Opinion leaders Institutions and Scientific or Medical Societies International Medical Development / Global Project Team (GPT) personnel Authority And Reporting Lines This position reports into the medical department- - Senior Manager RMA / Head RMA LOCATION: This function is field based. Ideal Candidate Criteria Graduate or Post Graduate Medical Degree in Pharmacology (Preferable) or Allied Sciences Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general. Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls. Solid knowledge of the pharmaceutical environment and excellent skills to build stake-holders relationship. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. A good command over spoken and written English Career Development Possible career development roles: Manager-Medical Affairs or Medical Advisor Head of Affiliate Medical Area Medical Advisor EPD Strategic Medical Affairs Clinical Development, GPRD, I & D Product Management

Abbott India Limited Job Purpose JOB DESCRIPTION As a Therapy Business Manager you will be responsible for developing and implementing all sales strategies in the assigned market. Further you will drive primary and secondary sales, ensure brand presence in the assigned market and manage the distributor network to achieve desired sales/business objectives. Roles and Responsibilities in detail Business Generation & Development Achieve monthly, quarterly, half yearly and yearly sales target by promoting company’s product ethically to customers as per the business plan Having science-based discussion with doctors and chemists for promotion of product in clinic and at chemist place Organizing Camps (CME) as per the division strategy and customer needs To plan and conduct merchandising and sampling activity as per Division strategy. Facilitate the process of successful new product / products launch in the territory by undertaking correct identification and targeting customers for the new product, meet them at pre-determined intervals, effective in clinic / trade promotion and share feedback with the company Execute the customer management plan to ensure that all the customers are covered as per the plan and meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division / therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy / division. Prescription audit for Abbott brands and other competitors’ brands To create and update customer list having specified number of doctors / chemist (Trade) as per the therapy / product requirement and maintain the same in physical / electronic format. Identifying potential town and appointing distributor and customers (trade) in line with business philosophy Brand Management Ensuring the visibility of Abbott brands on retailers’ outlet as a part of brand promotion strategy To carry out activities across trade and clinics for brand visibility To plan and attend Retail meets, Market Blitz etc. for sales growth Generate POBs for Abbott brands as per the business plan Recommend appointment of a party as a distributor after evaluating its commercial standing, credit worthiness and personal assets. Ensure that stock and sales statements have been sent by the distributors on due dates Ensure that the claims of the distributors are settled by company within specified time limits Responsibilities You are manager of the company in your territory and will be authorized to build company’s reputation in your territory. You will be responsible for practicing and leading other junior team members of the company by setting personal example of excellence in: Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, FCPA , Pharmacovigilance to ensure compliance Conformation to all financial and administration systems, compliance to statutory and regulatory norms of the company and laws of the land Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring and Enduring Ensure high level of customer service and manage any difficult customer situations. Ensure compliance with internal and external guidelines and ensure minimal comments in audits and other inspections Ensure transactions and orders are processed with a high level of accuracy and commitment in order to satisfy customer needs Manage attrition of customer and resource bases Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programmes and any other programmes undertaken by the company to equip you or activities for performance of your job or promote the sales of product of the company or to improve company image. Ensure adherence to EHS policies, procedures, rules and regulations. Attend all required EHS trainings as applicable. Wear safety gears (e.g. Helmet) while riding on two-wheeler. Report any EHS incidents and/or near misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision. Authorized Signatory

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors, Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture, Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience ( e-g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Ability to establish and meet priorities, deadlines, and objectives, Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref 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 Show