1158 Pharmacovigilance Jobs

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture 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 worlds 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. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate 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 Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

About Pacifix Research: Pacifix Research is a leading training and placement institution specializing in Clinical Research, Medical Coding, Pharmacovigilance, and related healthcare training programs. We’re passionate about preparing our students for rewarding employment opportunities in the healthcare industry. Job Description: We are looking for a freelance Medical Coding Trainer (Should be CPC Certified) to join our team and deliver high-caliber training sessions for our students. As a CPC trainer, you will be responsible for: ✅ Providing training sessions (online / offline) to prepare students for the CPC certification exam. ✅ Designing training material and practice exams. ✅ Providing guidance, clearing doubts, and mentoring students toward successfully obtaining their CPC credentials. ✅ Staying updated with the latest coding guidelines and industry practices. ✅ Assessing student progress and offering constructive feedback. Requirements: ✨ CPC certification (AAPC) is mandatory. ✨ At least 2–3 years of coding experience. ✨ Prior training or teaching experience is a plus but not required. ✨ Ability to explain complex coding concepts in a clear and simple way. ✨ Excellent communication skills (English). ✨ Reliable internet connection for conducting online sessions. ✨ Flexible hours (depending on batches). Compensation: ✅ Competitive pay (depending on experience). ✅ Flexible freelance schedule. ✅ Opportunity to collaborate with a growing training institution. How to Apply: If you’re passionate about mentoring future coding professionals, please apply through Indeed with your updated resume or portfolio. We look forward to welcoming you to our team at Pacifix Research! Job Types: Part-time, Permanent, Fresher Pay: ₹20,000.00 - ₹25,000.00 per month Expected hours: 10 per week Schedule: Evening shift Monday to Friday Education: Bachelor's (Preferred) Experience: medical coding trainer: 1 year (Preferred) License/Certification: CPC (Preferred) Work Location: In person Expected Start Date: 01/07/2025

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com. Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver No Performance Parameter Measure 1 Process No. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback 2 Self- Management Productivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience: 1-3 Years. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Process the adverse event reports from any source as per client/sponsor agreed plans. Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems; Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA, if applicable to Determine lists against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed. Ensure case receives appropriate medical review. Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to- o Maintenance of tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, as required, within study specified timelines. Support with quality review or peer review of the processed reports. Assist and/or complete the database reconciliation and the associated activities, as applicable. Maintain study/project level documentation as per the agreed requirements, as applicable. Support with training of PSS staff and mentor the team as needed. Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed). Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting, and pharmacovigilance. Assist in the preparation for client meetings and liaise with client contacts, where appropriate. Assist in Quality issues management and support audit and inspection preparation, as needed. Ensure compliance of operations with governing regulatory requirements and applicable study/project plans and take responsibility for quality of data processed. Assist in the preparation of client meetings and liaise with clients where appropriate ¨ Any other duties as assigned by management. The above job duties are completed by the staff as applicable, depending on the role they are assigned to. Qualifications (Minimum Required) Non-degree + 1 year of Safety experience or 3 years relevant experience. Associate degree + 1 year of Safety experience or 2 years relevant experience. BS/BA + 1 year of relevant experience. MS/MA + 1 year of relevant experience. PharmD + 1 year of relevant experience. For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player and offer peer support as needed. Good written and verbal communication skills. Ability to work independently with moderate supervision. Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred. Preferred Qualifications Include Office Environment or remote. Learn more about our EEO & Accommodations request here. Show more Show less

Summary Responsible to ensure case processing and ancillary activities in compliance with PS&PV business rules, standard operating procedures and regulatory requirements. Responsible for preparation and maintenance of manuals and other relevant/assigned documents Subject matter expert for cross-sub functional projects within PS&PV Lead implementation of new process and process amendments/changes About The Role Major Accountabilities: Monitor all case processing related activities to facilitate oversight on External Service Providers (ESP’s) quality and compliance of deliverables Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality. Perform Argus data entry as needed. Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered the safety database to ensure accurate and consistent data entry/quality. Coach/Train/Mentor other team members including ESPs, as required Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics Lead the preparation and maintenance of manuals and other relevant/assigned documents Participate in the creation and maintenance of training material and communications for Novartis and ESPs. Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process. Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement (VA) and other such safety management plans Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings Assess and analyze case processing related queries from Health Authorities and prepare and share the responses within the timelines. Support in-collaboration with other functions within PS&PV to facilitate process improvements Collaborate with Data Management team to enable reconciliation for locking of Clinical database Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products. Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead the testing activities for case processing related safety systems/IT applications. Lead PS&PV Operational Projects and support high complex/critical projects or database validation activities as required Minimum Requirements Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. 8+yrs of Industrial experience with 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility Good professional verbal and nonverbal communication skills Experience in Document writing desirable Self-motivation and proactive stance to work Sense of urgency and commitment for timely completion of activities Previous Pharmacovigilance data entry experience is desirable. Strong negotiation and ability to operate effectively in a global environment and across line functions 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 patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

About Alkem: Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India. Job Purpose: To actively contribute to the organization/division by taking responsibility for the scientific, technical and ethical soundness of all policies, statements and endeavors. To support the division medically in all activities related to the portfolio and provide high quality and timely service to internal and external stake holders. Responsibilities: To actively support development of promotion of allocated portfolio under supervision from the Line manager or the mentor, provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines Under supervision from the Line manager or mentor, create/review promotional, training, and Continuing Medical Education (CME) material in compliance with relevant industry codes and medical correctness In consultation with the Line manager or mentor, participate/facilitate/conduct customized promotional/educational interactions with Key Opinion Leaders (KOLs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, medical projects and studies In consultation with concerned stakeholders plan research projects and develop / review / approve protocol synopsis/final protocols/supporting documents per need Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies Impart medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives. Provide pre-launch and launch training to sales staff for new products Support New Product Evaluation (NPE), Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products. Support organization efforts at developing local formulations/line extensions through literature search/recommendations Support regulatory team by means of writing/revising/reviewing labeling documents for products as per relevant SOPs Support Pharmacovigilance activities by documentation and reporting of Adverse Events in a timely manner. Qualification : MBBS & MD Pharmacology (Mandatory) Experience : 1 to 3 years of experience in medico marketing Show more Show less

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience: Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist Job Summary: The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations and facilitating efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects. Key Responsibilities : Management of Global and Local SDEAs (SDEA / PV clause / Pharmacovigilance Agreement / Vigilance Agreement, PV Agreement for Clinical Supply, Divestments) for investigational, post marketing, marketed products, vaccines and medical devices. Review and assessment of PV obligations from contracts on different type of reports ICSR processing and timelines, PSURs/PBRERs, RMPs, Signal detection, Clinical study reports, periodic line listings, literature screening, labeling etc. to ensure accurate information is entered in the database. Management of Safety database related configuration requests and updates. Build and manage reports (Business Partner lists) periodically from the Contract management database to provide the operational functions with the latest contacts list for implementation in their processes or systems Maintain a database of all agreements and track their status, expiration dates, and amendments. Provide guidance on SDEA-related issues to stakeholders and non-stakeholders. Ensure timely execution of SDEAs in the database to support project timelines. Strict adherence to the standard operating procedures (SOPs) and guidelines. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. Provide support in ad-hoc activities to support the periodic aggregate teams for preparation of PSURs/DSURs Efficient in mailbox management and reconciliations. Conduct training sessions on SDEA processes and requirements for relevant staff. Perform Quality check on the processed data entries. Monitoring of Key performance indicators (KPIs) and metrics. Stay current with global pharmacovigilance regulations and industry best practices. Participate in audits and inspections related to safety data exchange processes. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred. 2-3 years of experience in pharmacovigilance, clinical research, or a related field. Knowledge and Experience : Related experience in drug safety/ pharmacovigilance and contract (SDEA/PVA) management is desirable Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge of pharmacovigilance terminologies on Individual case safety reports, Aggregate safety reports, Signal and risk management, and related regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge about the master service agreements and terminologies. Experience in management of the ICSRs in safety database. Understanding of medical terminology and adverse event coding. Experience in automation / artificial intelligence would be an asset. Desired Skills: Sound knowledge of drug safety, data analysis and evaluation of safety data Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Role: Clinical Operations Support Required Technical Skill Set: Highly skilled with Veeva eTMF Application Experience: 5 to 8 Years Work Location: Mumbai, New Delhi, Indore, Bangalore , Hyderabad, Pune, Lucknow, Chennai, Kolkata Desired Competencies (Technical/Behavioral Competency) Must-Have: Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar). Highly proficient in Information Technology systems, including Microsoft Office suite. Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between. Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference. Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects. Strong analytic skills for large quantities of compliance, risk management and clinical data. Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development. Good-to-Have: Veeva Vault admin certification is required Experience with Veeva RIM Connectors is preferred Regulatory Information Management: Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM. Ensure that regulatory submissions comply with applicable local and international regulations and guidelines. Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents. System Configuration and Maintenance: Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows. Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution. Data Management: Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones. Implement data governance practices to maintain compliance and quality of regulatory data. Cross-Functional Collaboration: Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions. Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities. Regulatory Compliance: Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices. Participate in audits and inspections as necessary, providing documentation and system access as required. Responsibility of / Expectations from the Role : Should able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA) Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM Align with Support Team on current issues and initiate problem management. Prepare and update application related documentation (Operational Instructions, User Manuals). Processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality. Show more Show less

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Role Summary MSL embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimise medical practice and drive appropriate adoption of BMS medicines. The MSL role is a field-based role. It is anticipated that a MSL will spend a minimum of 60-70% of their time in the field with external customers. The primary role of MSL is to develop and maintain contacts with Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer-to-peer discussions aligned with medical strategies and needs expressed by the stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management and BMS products in a fair and balanced way and includes appropriate Health Economics and Outcomes Research (HEOR) data. Key Responsibilities External Environment and Customer Focus Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1 1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Job Responsibilities Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and identifying service areas and solutions and work with the operational leadership to build capabilities Participate in the analysis and definition of efficient, cost-effective and creative solutions that deliver competitive value propositions to the industry Build partnerships with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions, etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have MBBS/MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is an added advantage Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development Knowledge of pharmacology, toxicology, and clinical trial methodology Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance Strong analytical and problem-solving skills Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams Demonstrated ability to prioritize tasks and manage multiple projects simultaneously Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) Good communication skills and relationship building skills Good to Have Equal Opportunity Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit, and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN Show more Show less

PRIMARY JOB FUNCTION Responsible for the maintenance and support of the PV Global Safety Database and associated systems. CORE JOB RESPONSIBILITIES Application support for all validated IT applications used by Global Pharmacovigilance (GPV) Consulting users to define best solutions for business requirements Managing and conducting optimization and upgrade projects Acting as an interface between GPV, Abbott IT, and software vendors Communicating with external service providers and software vendors Functionally managing external team members and ensuring adherence to defined processes SUPERVISORY/MANAGEMENT RESPONSIBILITIES Direct Reports : None Indirect Reports : None POSITION ACCOUNTABILITY/SCOPE Maintain the Global Safety Database and other IT applications used by GPV in a validated state Works with supervision and guidance MINIMUM EDUCATION Degree in IT, documentation sciences, or comparable education Good command of the English language MINIMUM EXPERIENCE/TRAINING REQUIRED Minimum 5 years’ experience in maintaining Safety databases (preferably ARISg) – mandatory IT experience in the pharmaceutical industry and validation experience – mandatory Excellent understanding of PV processes and regulatory requirements Advanced IT and programming skills: SQL, Oracle, Java, XML Strong communication and presentation skills in English Training as per assigned ISOtrain curriculum

JOB DESCRIPTION Work Experience (Total number of years/ experience/ background or equivalent): Total experience (in years): 15Experience in current role (in years): 6.5 YearsWork Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function – To drive technology transfer for Third party manufacturing, Loan license projects, Abbott’s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements.Core Job Responsibilities - To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer.To prepare Master formula record & Technology transfer protocol for products identified for transfer.To Review receiving site’s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation.To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches.To review executed process validation batch documents & support FLQR approvals. To service, trouble shoot and solve production process problems at manufacturing site.To acquire sufficient process understanding at current manufacturing site to enable effective investigations of commercial batch failure or market complaints and to contribute towards appropriate CAPA.To carry out due diligence of new sites with focus on formulation and required infrastructure and support new product acquisitions & product certifications.To work towards improving knowledge base for handling of Parenteral products in addition to the other dosage forms such as Oral solids, Oral liquids, Topicals, etc.To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification and Material Harmonization. To initiate, review & approve change controls in Soltraq.To author, review & approve technical documents in Darius. To extend support to NPI activities like Dossier review, Product certification & FLQR approval.To extend support to I&D for new product launches, review & approval of technical documents, batch monitoring & FLQR approval.To keep track of ongoing projects and update senior management beforehand.

As a THERAPY BUSINESS MANAGER you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Division's success. ROLES AND RESPONSIBILITIES IN DETAIL TERRITORY BUSINESS PLANNING: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations 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. BUSINESS GENERATION & DEVELOPMENT: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. 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 programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. 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. EXPERIENCE/TRAINING REQUIRED 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. #LI-DNI

Skill required: Pharmacovigilance Operations - 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? Drug safety associate Drug safety associate 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 Show more Show less

Company Overview: One Vector is a rapidly growing IT professional services startup specializing in AI/ML, Data Science, Analytics, IT Quality/Compliance, and Pharmacovigilance for biotech companies. Our mission is to empower biotech organizations with cutting-edge solutions and expert insights to drive their success. As we continue our rapid expansion, we are seeking a dynamic and experienced Computer System Validation (CSV) Specialist to join our team. Position Overview: We are seeking a highly skilled and motivated Software Validation Engineer professional to lead and support the validation lifecycle of GxP regulated computerized systems. In this client-facing role, the ideal candidate will have a strong background in computer systems validation (CSV), quality systems, and Software Development Life Cycle (SDLC) principles. This role is pivotal in maintaining the integrity, reliability, and compliance of digital systems supporting manufacturing, laboratory, and business functions for our clients. This candidate will act as a trusted advisor to our clients, guiding them through the complexities of regulatory compliance while also ensuring the effective implementation and ongoing management of their computerized systems and Lifecycle procedures with Data Integrity requirements. Exceptional communication skills and the ability to forge strong relationships with clients are essential for this role. The successful candidate will be strategic, results-oriented, and committed to driving the company's growth in the biotech sector. Key Responsibilities: Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review. Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), Validation Reports (VR), and DM (Data Migration) Protocol & Scripts. Oversee vendor qualification assessments and documentation reviews and approvals to ensure third-party systems align with client validation expectations and regulatory standards. Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 Conduct risk assessments for computerized systems to identify potential gaps in compliance. Review and identify validation deviations and resolve deviations with appropriate corrective/ preventive actions Develop validation strategy and documentation for cloud-based and SaaS GxP systems, ensuring alignment with client IT controls, cybersecurity policies, and data residency requirements. Provide Quality Review and Assessment of associated change requests related to processes, IT infrastructure, equipment and computer systems. Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management. Provide recommendations for mitigating risks related to data integrity, security, and system functionality. Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance. Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts. Provide guidance on data integrity principles and ensure alignment with industry standards. Responsible for other duties and projects assigned Qualifications: Required: Bachelor's degree in engineering or scientific discipline. IT Quality Assurance professional with a minimum of 9 years of experience with computerized system validation in Life Sciences industry. Experience validating systems such as LIMS, MES, ERP, QMS, or other laboratory/manufacturing software. Proficiency in authoring, reviewing and executing computer validation documentation (URS, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR). Proven track record of working with regulatory and industry frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC. Ability to work independently and collaboratively across cross-functional teams. Familiarity with audit readiness and experience supporting regulatory inspections or internal audits. Preferred: Master’s degree in a relevant discipline. Experience with QMS software implementation is highly desirable. Experience working with SaaS systems, data integrity programs, and GxP cloud validation strategies. Familiarity and/or industry certification with tools like ARISg database, QMS software platforms such as MasterControl, Veeva Vault QualityDocs/Quality Suite/Safety, paperless validation tools (Kneat, ValGenesis, or similar). Experience of working for US/EU based clients is a plus Show more Show less

Job Overview 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 Show more Show less

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s 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 product’s 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.com Show more Show less

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The purpose of the Senior Associate/Lead, IT Systems Business Quality Assurance (BQA) role is to support the development and implementation of quality systems strategy and activities to support the Data and Analytics and Global statistical science organizations goals and objectives for IT systems. In support of this mission, the purpose of the role of BQA is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The BQA will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of quality systems and assuring that these systems are aligned with appropriate quality and regulatory requirements. The BQA will act as a contact person regarding quality and business process compliance concerns with IT Systems in the clinical data flow. Primary Responsibilities Ensure local implementation of the Safety and Efficacy Quality System (SEQS) Review regional and/or local SOPs versus global policies. Review quality system documents and provides feedback. Recommend new procedures or changes to existing procedures where applicable. Provide quality oversight for compliance to SEQS. Escalate compliance issues to management locally and globally as appropriate. Ensure inspection readiness and compliance to global, regional, and/or local regulations Assist in interpreting relevant pharmacovigilance regulations and guidelines and acts as a contact person in the regional center and/or affiliates. Perform quality self-assessments. Facilitate audits and inspections. Coordinate audit responses including Trackwise system documentation. Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc. Ensure the implementation and maintenance of regional and/or affiliate Quality Plan(s) Document the regional and/or affiliate quality systems requirements ensuring clear accountabilities. Manage the regional and/or affiliate quality plan(s). Provide updates to quality and business owners. Implement and manage Quality Systems Provide consultation on the integration of quality into business processes. Support the business on the application and facilitation of quality systems (deviations, notification to management, change control). Consult on root cause analysis for deviations. Drive trending of metrics to improve processes and compliance Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions. Monitor completion of deviations, CAPA related to deviations and change controls. Monitor completion of audit responses through metrics. Provide updates to management. Share key learning to drive simplification and replicate best practices in the region and globally. Coordinate quality improvement initiatives. Seek and implement simplification and process improvement. Information Technology Quality Support responsibilities Review, and approve as appropriate, documents associated with the development and maintenance of IT systems. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. Participate as a member of the IT Change Control Board as applicable. Coordinate interfaces with other related systems. Other Responsibilities Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections). Review and approve change requests and validation documentation for IT systems. Minimum Qualification Requirements Bachelors or Masters Degree in a science or health care related field. Three years’ experience in quality and/or data management or statistics. Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GMP, GCP, etc.). Demonstrated ability to communicate effectively, both written and verbal, and to influence others. Demonstrated ability to prioritize and handle multiple concurrent tasks. Demonstrated ability to apply risk-based decision making in a regulated environment. Other Information/Additional Preferences Demonstrated ability to work in a global environment. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Show more Show less

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Azurity is seeking an experienced in-house counsel to support its Global Operations, Supply Chain & Alliance Management Function with legal responsibilities which include contracts, legal documentation, strategizing, and advisory. The candidate must be experienced in understanding pharmaceutical business, processes and transactions, and be involved in taking strategic decisions and providing legal guidance related to manufacturing, supply and ancillary services, handling cross-border contracts, dealing with internal stakeholders and counterparties globally, well versed managing Contract Life Cycle Management tools, and should have strong experience. Duties And Responsibilities Stakeholder Management Serve as a strong Legal Business Partner for the relevant departments. Gain a deep understanding of the business, products, strategies, transactions, and various issues by aligning with the relevant departments. Regularly attend meetings, proactively identify legal issues and highlight risks, and provide solutions to mitigate by collaborating with the relevant departments. Ensure all legal requirements are completed within stipulated timelines to facilitate smooth transactions for the relevant departments. Preemptively track all important dates and events, and take actions accordingly. Work closely with India General Counsel and other legal team members. Contracts Draft, review and negotiate wide range of pharma contracts (domestic as well as cross border) such as Manufacturing and Supply Agreement, CDMO and CMO Agreements, Development and Supply Agreement, Technology Transfer Agreements, API Supply Agreements, Master Service Agreement, Quality Agreement, Pharmacovigilance Agreement, Scope of Work, Product Addendums, Consulting Agreements, etc. Ensure that the agreements drafted and negotiated as per company’s playbook and are executed in timely manner. Ensure risk mitigation, protection of intellectual properties, and commercial interests of the organization by way of contracts. Inform and guide stakeholders on the interpretation and purposes of contracts related provisions. Identify and assist stakeholders with resolution of issues affecting completion of Agreements. Format documents for finalization. Manage the legal contracts folder. Gather, quantify, and report on legal department metrics. Contract Lifecycle Management Platform As a highly system-driven organization, Azurity has implemented and uses a contract lifecycle management software / tool, namely Ironclad Manage and oversee Azurity’s contract life cycle using Ironclad, ensuring contracts are properly tracked, stored and managed. Support the creation of contracts by gathering and vetting required inputs, including business terms from business and functional owners. Guide internal clients through the contract request process. As intake coordinator, review contract requests and statements of work against Perform review of expiring contracts and manage renewals and amendments. Be experienced and well versed with contract management software / tools – similar to Ironclad (if not better) Provide advice and support to various departments on matters related to contracts as well as Ironclad. Align with legal, finance and business team members to ensure that Ironclad is used in the most efficient manner Develop and implement (or assist to) procedures to improve the efficacy of Ironclad Act as liaison between internal clients and the legal department for timely processing of contracts. Handle status inquires, process questions, and direct inquiries to the appropriate attorney. Metadata abstraction and tagging into the Contract Lifecycle Management Tool – Ironclad. Co-ordinating with stakeholders for execution through Docusign. General Duties Conduct legal issue identification, investigate factual issues, and analysis and legal risk assessment. Interpret and respond to requests for information, documents, and status-up-dates-from colleagues seeking legal support. Preparing various reports and presentations. Provide support in transactional due diligence. Perform special projects and general support for the Legal Department. Any other duties as may be entrusted from time to time Qualifications LL.B from a reputed university 3-9 years of related experience, preferably with at least 3 years in-house pharma legal experience; Minimum of 3 years of applicable experience on contract life cycle management tool; Experience of supporting in-house legal department; Basic understanding of pharmaceutical industry – development, technology transfer, supply and manufacturing, contract manufacturing, API Supply, Clinical Trails, Licensing, etc., Highly skilled in Microsoft Office suite; experience in DocuSign and Box.com preferred; Strong verbal and written communications skills to enable communication with legal colleagues and stakeholders present globally, particularly in the US, Ireland, and other EU countries. Ability to consistently solve problems with a high degree of independent decision-making Strong organizational skills with careful attention to detail. Strong interpersonal skills and must be highly team oriented. High level of professionalism and ability to maintain absolute confidentiality. Ability to build business acumen and understand core elements of the applicable business area. Ability to handle multiple complex tasks and high volume of work in a team-based environment and consistently meet deadlines. General tech savvy and able to learn new skills necessary to keep pace with an ever-changing landscape. Benefits We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following: For a list of benefits, please see our benefits listing on our careers page at www.azurity.com/careers/ By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient 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? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable 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? •Understanding of Pharmacovigialnce •Experience in Medical Review of ICSRs •Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable MBBS,MD

We are looking for a Life Science Senior Content Specialist to join our team in Hyderabad/Noida. This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal. The team consists of 20 people located in Spain and India and is reporting to the India-based Team Manager. We have a great skill set in the analysis of drug safety and toxicity data and we would love to speak with you if you have skills in that area About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Pharmacy, Pharmacology, Toxicology, Biology, Biomedical Sciences, etc.) Min 5 years of experience in drug safety, toxicology, pharmacovigilance Excellent English written and oral communication skills Attention to detail, results orientated, enthusiastic, determined to achieve and shows commitment It would be great if you also had . . . Ability to analyze large volumes of structured or unstructured data. Ability to delve deep into content and results. Interpersonal skills and the ability to work independently and collaboratively with a team Self-starter with the ability to multitask and prioritize across projects to meet deadlines Good skills of problem-solving and good judgment in decision-making and setting priorities. What will you be doing in this role? Selection of appropriate scientific articles and conference content for the project. Analysis and interpretation of published data (clinical trials, journal articles, reviews, meta-analysis, congress communications, drug approval reports, etc.) Collection and curation of information on risks and safety of drug products (recording, archiving, updating and evaluating the information) Writing case studies, reports and reviews Maintain informed discussions with experts and customers About The Team Our editorial team is a group of 20 people creating and delivering content for OFF-X, a translational drug safety intelligence portal that allows user to easily identify new safety liabilities. We are a global team based on India and Spain with more than 50 years of experience in the sector. We create and classify content for more than 300 references every week, including Journals, Congress publications and Regulatory documents. In this team you will have the opportunity to be up-to-date with all the new advances in the drug development industry and you will be constantly learning new things. Location - Hyderabad / Noida At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

Description Safety & PV Specialist I-Japanese -Pune Office 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 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. Qualifications 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. Show more Show less

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient 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? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable 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? Understanding of Pharmacovigialnce Experience in Medical Review of ICSRs Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Show more Show less