Drug Safety Physician (Gurgaon: On-site) - DDReg pharma Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects. Duties and responsibilities Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs. Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks. Communicating safety information to regulatory agencies, healthcare professionals, and the general public. Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed. Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs. Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety. Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards. Reviewing and evaluating the safety and efficacy of new drug candidates during the development and approval process. Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately. Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders. Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs. Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients. Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market. Being responsible for the overall safety of the drug, from preclinical development to post-approval. Education & Experience Bachelor s or Master s degree in Medical or Dental Sciences Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years ). Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong understanding of Medical Sciences Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Apply Online First Name Last Name A valid email address is required. 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Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate . 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

JOB RESPONSIBILITIES The role of Analyst in Valuations & Portfolio Reporting will manage support for valuations and portfolio reporting, including portfolio analytics and property-level performance. The role is a liaison with Customer North America, and in turn Client’s asset management, portfolio management and finance teams in order to support monthly and/or quarterly valuation processes. This position will report to the Team Manager. The Valuations & Portfolio Reporting department in COE works as an extended arm for similar regional department working within Customer Asia, Customer Europe & UK and Customer North America Valuations & Portfolio Reporting department. Reports to Lead Analyst/Team Manager/Manager How You Add Value (including but are not limited to) The role of Analyst in Valuations and Portfolio Reporting will provide valuation and analytical support and performance reporting as follows: Supports the quarterly internal valuation support cycles together with Customer and in turn, Client. Manages and maintains robust Argus cash flow models to be exported into excel valuation models. Effectively obtains property-level information from various source systems or portfolio companies in order to routinely update cash flow models with actual leasing or changes in market leasing assumptions, other income, operating expenses or capital expenditures. Provides critical analysis of changes at the property- or investment-level in order to report on the cash-flow and valuation changes. Analysis of property- or investment-level changes is at the equity value. Analyzes market conditions from sales comparable and other sources in order to drive assumptions and assess the value of the assets. Supports the entire valuation reporting process with Customer and in turn Client stakeholders and revise valuation models based on feedback. Assists in ad hoc requests or special projects at the request of the Customer or at the request of Client or portfolio companies, most notably data and analytics for real estate valuations. Continues to collaborate and enhance processes and procedures to deliver best in class service. DESIRED S & COMPETENCIES Real estate knowledge, including broad market fundamentals and financial cash flow modelling, required. Drive and desire to learn new technologies and grow technical and functional skill sets. Strong MS Office, particularly Microsoft Excel, skills required. Argus Enterprise experience required. Experience with US GAAP and real estate accounting and/or management systems preferred. Passion for making business processes more efficient and successful Excellent communication, problem solving and interpersonal skills necessary. Ability to multi-task and manage shifting priorities in a fast-paced environment Strong attention to detail and ability to work both independently and in a team environment. Some travel internationally may be requested. Mandatory Skills: Institutional_Finance_Buy_Side_Others. Experience3-5 Years.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Fortis Hospital Mohali is hiring for Head Clinical Pharmacology interested candidates can share profile at baljinder.singh@fortishealthcare.com

Job Summary The Team Manager-CDM/PV role is crucial in overseeing the Pharma Research & Development processes within our organization. With a hybrid work model and rotational shifts the candidate will manage and optimize case processing and research activities. This position requires a minimum of 5 years of experience focusing on enhancing productivity and ensuring compliance with industry standards. Responsibilities Manage and oversee the Pharma Research & Development processes to ensure efficient workflow and compliance with industry standards. Coordinate with cross-functional teams to optimize case processing and research activities enhancing overall productivity. Implement strategies to improve data management and pharmacovigilance processes ensuring high-quality outcomes. Monitor and evaluate project progress providing insights and recommendations for continuous improvement. Facilitate communication between departments to ensure seamless integration of research and development activities. Develop and maintain documentation related to case processing and research ensuring accuracy and accessibility. Provide training and support to team members fostering a collaborative and productive work environment. Analyze data to identify trends and opportunities for process optimization and innovation. Collaborate with stakeholders to align project objectives with organizational goals and industry regulations. Ensure adherence to regulatory requirements and guidelines in all research and development activities. Utilize technical skills to troubleshoot and resolve issues related to data management and case processing. Drive initiatives to enhance the efficiency and effectiveness of pharmacovigilance operations. Support the development and implementation of new technologies and methodologies in research and development. Qualifications Possess a strong background in Pharma Research & Development with at least 5 years of relevant experience. Demonstrate expertise in PV Case Processing and Research and Development showcasing domain skills. Exhibit proficiency in data management and pharmacovigilance processes ensuring high-quality outcomes. Display excellent communication and coordination skills to facilitate cross-functional collaboration. Show ability to analyze data and provide actionable insights for process improvement. Hold experience in managing documentation and ensuring compliance with industry standards. Have a proactive approach to problem-solving and process optimization.

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

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients. We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here. Job Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Responsibilities: Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations Review and analysis of clinical data to ensure the safety of study participants in clinical studies Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments Address safety issues across the study from sites and the study team Review listings for coded events to verify Medical Dictionary for Regulatory activities Participate in bid defense meetings Assist in Pharmacovigilance activities Identify Program risks, and create and implement mitigation strategies with Clinical Operations Ability to organise and lead clinical development advisory boards and safety monitoring boards Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines Review and sign off clinical documents with respect to medical relevance As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them. Qualifications Medical Doctor (MD) degree with Board Certification/Specialization in (Oncology, Gastroenterology, Infectious Disease or Onco-Hematology) is an essential requirement. Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly preferred. Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organisation. Must possess excellent leadership, communication, presentation, and organisational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance. Proficiency with MS Office applications. Additional Information Join our highly dedicated team of clinical research professionals with +250 Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists. Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350735 Show more Show less

Essential Skills: 2-10 years of total IT industry experience, with at least 3 years in Clinical or Regulatory solutions for Life Sciences clients. Should be well familiar with Life Sciences Domain - Clinical Trials, Drug Safety, Pharmacovigilance Familiarity with the complete working of CSV tool Exposure to US Life Sciences market Experience of leading development team, working with client teams/SMEs and leading them through the project life cycle. A day in the life of an Infoscion As part of the Infosys consulting team, your primary role would be to get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight. You will develop a proposal by owning parts of the proposal document and by giving inputs in solution design based on areas of expertise. You will plan the activities of configuration, configure the product as per the design, conduct conference room pilots and will assist in resolving any queries related to requirements and solution design You will conduct solution/product demonstrations, POC/Proof of Technology workshops and prepare effort estimates which suit the customer budgetary requirements and are in line with organization’s financial guidelines Actively lead small projects and contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability Good knowledge on software configuration management systems Awareness of latest technologies and Industry trends Logical thinking and problem solving skills along with an ability to collaborate Understanding of the financial processes for various types of projects and the various pricing models available Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Client Interfacing skills Project and Team management Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350735 Show more Show less

Work Schedule Third Shift (Nights) Environmental Conditions Office Work Schedule Standard (Mon-Fri) Environmental Conditions Office Summarized Purpose: Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. Essential Functions Works independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff. Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency and accuracy, including review of peer reports. Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Qualifications: Education and Experience: Must be Life Science or Clinical Science Graduate or Post Graduate Should have 5+ years of experience in Case Processing related activities by using Argus database Should have hands on working experience in PMS & CT Cases. Available to join us Immediately Must be willing to work in NIght Shifts (IST 5:30 PM to 2:30 AM) Knowledge, Skills and Abilities: Thorough understanding of pathophysiology and the disease process Strong knowledge of relevant therapeutic areas as required for processing AEs Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately Proficient at complex clinical study administration including budget activities and forecasting Excellent oral and written communication skills including paraphrasing skills Good command of English and ability to translate information into local language where required Computer literate with the ability to work within multiple databases Proficient in Microsoft Office products (including Outlook, Word, and Excel) Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision Strong attention to detail Ability to maintain a positive and professional demeanor in challenging circumstances Ability to work effectively within a team to attain a shared goal Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, South Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350739 Show more Show less

We are seeking a skilled Business Analyst with experience in healthcare and life sciences to translate complex domain requirements into clear functional specifications. The role focuses on supporting product development initiatives by aligning business needs with technical solutions across the PDLC. Requirement Gathering & Analysis Business Analyst Product Development Lifecycle (PDLC) Pharmacovigilance (PV) ICSR IQVIA Vigilance Platform Clinical Trials Regulatory Affairs Medical Affairs Risk-Based Quality Management Veeva CTMS Safety Intelligence CluePoint Signal Oversight Labeling Management Product Traceability Randomization

DesignationService Executive - Solar EPC Business Primary Responsibilities: We are looking for a Service Executive in our solar EPC business. You will be a key member of our operations team, responsible for ensuring the efficient operation and maintenance of solar energy systems installed by our company. You will work closely with customers, technicians, and other stakeholders to deliver exceptional service and support. Reporting toEngineering Head Requirement 1.Strong technical knowledge of solar PV systems and components. 2.Excellent problem-solving skills and attention to detail. 3.Good communication and interpersonal skills. 4.Ability to work independently and prioritize tasks effectively. 5.Willingness to travel to project sites as needed. Key Result Areas: Internal: - Technical Support - Data analysis and Reporting - Process Improvement - Training & Development - Quality Assurance - Cross Functional collaboration External: - Customer Satisfaction - Service Delivery - System Performance (PR) Monitoring - Relationship Management - Regulatory compliance - Customer Feedback Management About The Role : - Perform routine inspections and maintenance tasks on solar PV systems to ensure optimal performance and longevity. - Diagnose and troubleshoot technical issues, including but not limited to inverter failures, wiring problems, and module degradation. - Coordinate with field technicians and subcontractors to schedule service visits and repairs in a timely manner. - Monitor system performance using monitoring software and tools and take proactive measures to address any deviations from expected output. - Maintain accurate records of service activities, including site visit reports, maintenance logs, and customer communication. - Provide technical support to customers over the phone, via email, or on-site, answering questions and guiding them through troubleshooting steps.

WE ARE HIRING Solar Technician, Operation Maintenance, Service Engineer Site Engineer O&M Alligator Solar (Alligator Energies Pvt. Ltd) We are looking for a Service Executive in our solar EPC business. You will be a key member of our operations team, responsible for ensuring the efficient operation and maintenance of solar energy systems installed by our company. You will work closely with customers, technicians, and other stakeholders to deliver exceptional service and support. Requirement 1. Strong technical knowledge of solar PV systems and components. 2. Excellent problem-solving skills and attention to detail. 3. Good communication and interpersonal skills. 4. Ability to work independently and prioritize tasks effectively. 5. Willingness to travel to project sites as needed. Key Result Areas Internal- Technical Support - Data analysis and Reporting - Process Improvement - Training & Development - Quality Assurance - Cross Functional collaboration External- Customer Satisfaction - Service Delivery - System Performance (PR) Monitoring - Relationship Management - Regulatory compliance - Customer Feedback Management About The Role : 1. Perform routine inspections and maintenance tasks on solar PV systems to ensure optimal performance and longevity. 2. Diagnose and troubleshoot technical issues, including but not limited to inverter failures, wiring problems, and module degradation. 3. Coordinate with field technicians and subcontractors to schedule service visits and repairs in a timely manner. 4. Monitor system performance using monitoring software and tools and take proactive measures to address any deviations from expected output. 5. Maintain accurate records of service activities, including site visit reports, maintenance logs, and customer communication 6. Provide technical support to customers over the phone, via email, or on-site, answering questions and guiding them through troubleshooting steps. 7. Collaborate with the engineering and design teams to implement system upgrades, modifications, or enhancements based on performance data and customer feedback. 8. Identify opportunities for service contract renewals, system upgrades, or additional services, and work with the sales team to secure new business or cross selling. Internal- Technical Competence - Process Improvement - Team Collaboration - Data Analysis and Reporting External- Customer Satisfaction - Service Delivery - System Performance (PR) Monitoring - Relationship Management Educational Qualification Bachelor's degree in electrical engineering, electronics engineering, Renewable Energy, or a related field. Previous experience in solar energy, EPC projects, or a related industry Work ExperienceMinimum of 6 months of progressive experience in Solar PV service, O&M, site engineer.

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, East Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350741 Show more Show less

Job Description Position Director - Drug Safety, Pharmacovigilance The Director, PV is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and for ensuring compliance with PV processes and regulations, company policies and procedures, and establishing & maintaining best practices. They are also responsible for managing and developing PV staff and for other activities as delegated by the PV Lead which may include but are not limited to management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues. The Director, PV may serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they serve as their back-up. The items listed below are activities that can be performed by the role and is applicable for all supported countries. Specific details of tasks and responsibilities of the local QPPV, Local PV Contact / Local Responsible PV Person role and Country PV staff may be further described in the section below entitled “Additional Local Specific Activities”. Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence. If serving as the local QPPV / Local PV Contact / Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations. May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable. Oversees and responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable). Serves as a SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations. Participates in and supports audits of contractual partners/vendors as necessary. Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation. Develops and maintains local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned. Supports the development and maintenance of local PV controlled documents (e.g., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current. Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable). Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity. Supports training of local company staff, distributors, vendors, and business partners and can provide training as applicable. Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable). May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable). May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system. As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable). May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable. As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable). As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations. As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable). Support local implementation of applicable business continuity plans (as applicable) Ensures the filing, storage and archiving of safety-related documentation in accordance with company’s policies and local requirements. Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures. Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions. Represents PV in cross-functional organizational and alliance partner forums as needed. Participates on local company committees and councils for matters impacting PV as assigned. May participate on special projects or rotational assignments within or outside of IPV as part of their professional development. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Adaptability, Adverse Event Report, Auditing, Audit Inspections, Communication, Compliance Monitoring, Data Management, Drug Metabolism, Drug Safety Surveillance, Drug Utilization Reviews, Global Program Development, Management Process, Periodic Safety Update Reports, Pharmaceutical Guidelines, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Regulatory Compliance, Regulatory Reporting, Social Collaboration, Strategic Planning, Strategic Thinking, Training and Development Preferred Skills Job Posting End Date 06/15/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R349967 Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, East Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350741 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 products 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 products 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 PharmacovigilanceICSR 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 skillsverbal 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

About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally, Main Responsibilities The overall purpose and main responsibilities are listed below: Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases Initiate and amend submission based on comments (as required) Support the writer with internal and external stakeholder communication Track the delivery of activities (including managing issues and risks) and support follow up Support required submission, compliance/ approval activities, and ensure compliance with publication processes and end-to-end publication management tools (e-g , iEnvision previously, Datavision/Matrix) and update as required with approval/compliance tools (e-g , PromoMats, NAYA) Support the management of the assigned publication or medical education in line with the agreed budget Support and manage as required external spend tracking (e-g , approvals, purchase orders, and goods received) Support adherence to associated compliance related activities and approvals (with internal stakeholder taking accountability for compliance) Collaborate effectively with stakeholders: Scientific communication global and/or local teams; and medical content enhancement teams, People: (1) Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated Global Business Unit and product with an end objective to develop education and communication content as per requirement; (2) Coordinate with Project Specialist and Project Managers to lead and develop SBO operation activities; and (3) Ensure new technologies are leveraged Performance: (1) Ensure publication/medical education materials (slide decks, abstracts, posters, and manuscripts etc ) are delivered, stored as per agreed timelines and quality; (2) Develop tools, technology, and process to constantly improve quality and productivity Process: (1) Support delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group; and (3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards Stakeholder: (1) Work closely with scientific communication/medical content enhancement teams to ensure the end-to-end effective project delivery of the designated publication/medical education deliverables About You Experience: 2-4 years post qualification experience Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: Project management; Scientific/Medical writing/communications; Pharma experience (including but not limited to therapeutic area/domain knowledge exposure; and/or publication submission) Education: University degree level (Graduate degree, preferably in science) Additionally, relevant advanced/postgraduate degree in life sciences/pharmacy/similar discipline desirable Languages: Excellent knowledge of English language (spoken and written) Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi ! null

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelors degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate

Hi, We are having an opening for Manager IT-Project support for our Gurgaon Location. Job Summary : Application support and lead will be responsible for the successful implementation of assigned projects. This role requires a deep understanding of Argus application and Pharmacovigilance area. Understanding in AI/ML, Artwork management is preferred. Job Description : Role and Responsibilities Argus upgrade application implementation support for PVG department AMS (Artwork Management System) upgrade and enhancements Support in AI/ML initiatives Execute the tasks defined in project plans, adhering to timelines, for successful implementation of assigned projects and activities Managing QMS Shall support internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably PVG domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications AI/ML development Oracle Argus Data processing and engineering Troubleshooting and problem-solving Familiarity with Big Data Technologies Performing Statistical Analysis

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage