1738 Pharmacovigilance Jobs - Page 18

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Kiran Hospital ( Samast Patidar Aarogya Trust ) is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Career Category Operations Job Description HOW MIGHT YOU DEFY IMAGINATION You ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goalsAt Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner . CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity. In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert ( SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events , working closely with Quality Leads in approving investigations , including root cause analysis (RCA) and C orrective & Preventive Action (C APA ) plans. Roles & Responsibilities: The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgen s R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners. Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis. Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation. Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads. E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS). Monitor s and ensure s adherence to timelines, escalating delays and risks as needed. Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices. Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations. Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles. Monitor s quality metrics and key performance indicators (KPIs) related to deviation and CAPA management. Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement. Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet Maintain s knowledge of current regulatory and quality practices/issues Maintain s the Global R&D CRQ and SMQ SharePoint sites Manage s the appropriate archival and retention of audit documentation. What we expect of you Basic Quali fi cations and Experience: Master s degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Additional Competencies/Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e. g. , Teams, WebEx ) Good team building skills and the ability to on-board new employees and develop them over time Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP . Experience working in a multinational environment with global teams. Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure Equal opportunity statement We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com .

Kenvue Is Currently Recruiting For A: Senior Specialist Global Pharmacovigilance System Operations What We Do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role Reports To: AD Safety Analytics and Systems Location: Asia Pacific, India, Maharashtra, Greater Mumbai Work Location: Hybrid What You Will Do Travel %: 10% Pay: (If compliant with country’s laws) What You Will Do The Senior Specialist, Global PV System Operations is responsible for supporting the Associate Director, Safety Analytics and Systems in the maintenance of Pharmacovigilance (PV) System Operations and partner with Information Technology (internal and vendor teams) on the implementation of new systems, maintenance of existing systems, applicable interfaces and providing support to users for the vendor supported systems. Key Responsibilities Responsible for system activities performed by vendor including but not limited to Argus analytics, set-up of Reporting rules (RRs), product additions, protocol configurations, and MedDRA/system upgrades to enable safety reporting in compliance with local regulatory requirements and/or third-party agreement requirements. Supervises activities performed by vendors by monitoring daily metrics including training metrics. Plays a key role in team meetings and daily liaison with the vendor team to identify and resolve support desk issues. Provide guidance and support to clarify procedures (e.g. training) to ensure compliance relating to support of reporting rules for Business Partners and Health Authorities. Contribute and Participate in Change Control process User Acceptance Testing (UAT) activities for vendor supported systems and Kenvue supported systems. Liaise with staff in GMSO (Global Medical Safety Operations) function and other external functions as appropriate to facilitate compliant, timely and efficient case processing and reporting activities including electronic (E2B) or manual reporting of Individual Case Safety Reports (ICSRs) to Regulatory Authorities, Business Partners, Ethics Committees and investigators in accordance with Worldwide Safety Regulations, corporate and regulatory guidance documents, corporate policies, and/or third-party agreements. Assist Manager/Associate Director in CAPA management and/or provide oversight to investigations, assigned CAPAs, Task Actions, Effectiveness Checks and associated documentation ensuring documentation accuracy, compliance with completion timelines, and inspection ready state of all documentation. Participate in audits and inspections regarding system operational activities associated with Global PV Systems Operations activities or other scopes as identified. Accountable for the development and implementation of Standard Operating Procedures (SOPs)/Work Instructions (WIs) relating to distribution rules set up and electronic reporting of safety information. Oversee vendor training and development activities. Maintain 100% compliance in all assigned training and maintain knowledge of department policies and procedures. Required Qualifications What we are looking for BA or BSc degree in health-related field or other related scientific degree/qualification. Broad knowledge of pharmacovigilance with experience in inbound case receipt, regulatory reporting, case processing and other areas of PV. Previous industry experience with a focus on consumer safety related areas. Typically demonstrated by a minimum of 5-8 years’ industry experience. Previous industry experience with system implementation. Ability to independently make decisions and understand complexities of Kenvue products and Adverse Event categories in order to properly establish accurate queries. Problem solving abilities to handle electronic and distribution rules issues and escalate when appropriate. Excellent verbal, written and presentation skills. Desired Qualifications: Previous Computer Systems Business Validation experience. Previous experience in Oracle ARGUS Safety including reporting rules and company product dictionary. What’s In It For You Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time & More! Learning & Development Opportunities Kenvuer Impact Networks This list could vary based on location/region Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities Participate in Design & Development of the Safety Compliance & Reporting needs Support digital vendor teams in Compliance & Safety Reports Development, Testing & Deployments Use the data published across enterprise for effectively integrating data from various sources while generating Reports Understand the Case Submissions Lateness reasons and propose and implement CAPAs Maintain Validation of Safety reports generated from LSRA Implement deployment of safety reports as per business needs Provide QPPV office with relevant reports for oversight activities Support incident & change management of LSRA, LSSRM, PSUR webpage tools Support PV Country & Global Teams during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis Participate in discussions with business stakeholders to understand Reporting requirements, document them and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams Maintenance of existing reports on periodic basis and during System Upgrades Work alongside vendor assigned staff for existing safety database during transition period, assist with incidents and escalations as needed as part of governance structure Participate in Report Automations using Dashboarding & Paginated Reporting tools & techniques Actively participate and contribute to the growing needs of Drug Safety Regulations Participate in any other assigned activities related to the PV domain Work in an Agile environment Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) and Cognos & Power BI Reports. Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager Reports Development experience using Cognos & Power BI Programming languages like – Python, R, Javascript DBMS skills – SQL, PL/SQL, Power BI – DAX Development knowledge in AI/ML, LLM, NLP modules is preferred Experience with development & analysis PV Reporting systems Experience in Compliance Monitoring Tools Experience with PV Signal Systems Experience in handling the ICSR Submission Lateness reasons and CAPAs related to it Experience and understanding of Pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems Knowledge of Computer System Validation processes and using ALM Good knowledge of MS Office Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance reporting Strong experience in IS and validation is required Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards, Good Pharmacovigilance Practices (GxP), Safety Reporting Requirements. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades Report Writing: Ability to write clear, concise, and accurate reports, including regulatory reports, internal analyses, and safety assessments. This includes the ability to translate complex data into understandable narratives. Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders. Education Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5 years’ Technical Experience in GxP systems preferably in PV databases Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets. Manages and leads a team of professionals in pharmacovigilance and collaborates with IPS Leadership and Heads of Patient Safety in Countries, to ensure an effective model is in place to support PV activities within the scope of IPS HYD. In addition, this role is responsible for leading, overseeing or executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader. Provides leadership and direct line management to IPS team members based in HYD. Contributes to the design and implementation of an effective IPS operating model in HYD to support in-scope PV activities for IPS, spanning multiple geographies and liaising with multiple Heads of Patient Safety, in applicable countries. Collaborates and supports cross-functional teams to ensure effective conduct of PV activities. Leads the ideation and continuous process improvements with the HYD team, to bring incremental business value-add benefit (increase quality, efficiency, consistency) and fully leverages available technology. Leads cultural awareness and ways of working within the HYD team to enable effective ways of working across multiple cultures and geographies. Provides feedback to IPS Leadership on the performance and effectiveness of the IPS operating model in HYD, to ensure its continuous improvement. Addresses any issues or challenges, with clear action plans, on any activity performed within the IPS operating model in HYD. Leads IPS HYD team communications and interactions locally (e.g. team meetings and connections with other PS teams). Leads the planning or contributes to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support/Lead Aggregate Report related activities. Lead the creation/update of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets. Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators. PV activity planning and tracking e.g. signal communications to Health Authorities. Collaborate and support cross-functional teams to ensure effective conduct of PV activities. PV Audit and Inspection support (including preparation, conduct and follow-up actions.) The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required. Functional and Managerial reporting lines into IPS. Excellent interpersonal, verbal, and written communication skills, with the ability to effectively engage across different geographies and cultures. Experience working across cultures and geographies is therefore highly desirable. Solid understanding of pharmaceutical organizations and their structures and pharmacovigilance systems. Able to research, compile and provide safety information in a clear, concise manner. Subject matter expertise in PV legislative matters such as global, regional and any other relevant legislation/guidance regarding PV (e.g., FDA, EMA, ICH, CIOMS). Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines. Utilizes effective problem-solving approaches to address PV issues, leads discussions on process improvement opportunities and co-solutioning with Leadership. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability. Previous line management responsibility, with demonstrable experience in developing talent. Operational Skills: Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows. Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods. Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams. Analytical Skills: Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data. Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments. Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality. Strategic Skills: Strategic Thinking: Integrates a diverse array of digital technologies digital strategies to enhance cross-departmental processes and medium-term PS objectives. Decision-Making: Uses multiple data sources and AI generated predictions to support decisions Change Management: Drives digital change initiatives, managing stakeholder expectations and overcoming resistance. At least 5 years' experience in the Pharmaceutical Industry, with a minimum of 3 years' experience working in Pharmacovigilance or in a closely aligned field (e.g., Regulatory, Clinical or Medical Information). University degree (health or life science) or nursing qualification. Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency) Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Overview Provide strategic leadership at customer (or strategic) account level for large post-marketing, clinical trial or combination programs or customer accounts, as assigned by senior management team. Act as a senior level point of contact throughout project duration for local and globally scoped deliverables with single/multiple Lifecycle Safety functions. Collaborate with global management team and integrated partners to develop and implement strategic initiatives / solutions and ensure global consistency. Essential Functions • Manage customer interface and communication for large programs or standalone projects. Represent Lifecycle Safety on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams. • Manage customer deliverables for assigned projects/programs. Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management. • Act as an account owner over a program or customer portfolio and therefore report program/portfolio level metrics and provide oversight of projects they do not directly lead. • Performs role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities. Formulates operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfil required customization of text and data. Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery. • Represents as Safety SME. Provide leadership and accountability for customer-facing collateral and operational support to deliver key customer messages, working cross-functionally and across the opportunity lifecycle, integrating lifecycle safety core message delivery into customer facing material, presentations and meetings. Collaborate with senior leadership to implement strategic initiatives and ensure global consistency. • Provide leadership structure for customer service interface from scoping stage, through proposal generation, bid defense to transition of work and service delivery; and throughout the development and commercial life cycle of the product. • Attend Joint Operating Committee Meetings and / or Governance meetings to provide portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner with customers at a Senior Management Level. • Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate. • Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc. • Ensure financial project performance through oversight of key performance metrics (i.e. revenue, direct costs, time-sheet costs, contribution margin). • Develop specialized expertise across the Pharmacovigilance spectrum (e.g. Global Regulatory, Regulatory reporting requirements), and apply this expertise within assigned projects, and cascade knowledge to PV Solutions team as appropriate • Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication. • Manage start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage. • Lead meetings with internal and external stakeholders. Provide project status updates, defines processes, project/planning strategy. • Provide leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams, to ensure projects/programs are delivered in accordance with customer expectations • Facilitate sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as needed. • Incorporate strategic options when defining project/program scope and processes with customer • Develop customer relationships into partnerships; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with existing customers. • Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross- functional strategic solutions within Lifecycle Safety service lines to meet customer needs. • Actively contribute during client and internal audits and inspections for assigned project. Liaise with Quality Assurance staff and management in the compilation of corrective action plans • Identify and drive departmental initiatives aimed at enhancing customer service, efficiency, quality, or employee engagement • Represent LS Leadership at select external and internal meetings. • Takes on a higher level of leadership within the department to mentor and support junior leads. • Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency • Perform other duties as assigned Qualifications • Bachelor's Degree Health science or other directly related field Req • Other Project Management Professional (PMP) Certification Pref • 6 to 7 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 6 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 3 years' project management experience Req Or • Equivalent combination of education, training or experience Req • In-depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures. • In-depth knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills. • Strong team management and leadership skills, conflict management. • Strong project management; planning and organizational skills. • Effective verbal and written communication skills including ability to network and lead teleconferences. • Effective collaborative, organizational and delegation skills. • Ability to establish and maintain effective working relationships with coworkers, managers and customers. • Ability to deliver on multiple projects and manage competing priorities. • Ability to manage ambiguity. • Effective business focus, marketing, sales skills. • Proven strong presentation; report writing skills and customer focus skills. • Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared accountabilities. • Independent judgment, negotiating, decision-making, and problem-solving skills. • Effective business acumen and financial analytical skills, tactical planning, budgeting. • Customer focused with effective relationship building skills. • Effective motivating, influencing and conflict resolution skills.

Summary Contribute to the transformation of Patient Safety and Pharmacovigilance (PS&PV) into a future–driven organization and enterprise level enabler of the overall Development and Novartis strategy. Provide project management expertise to key PS&PV projects, ensuring successful execution of project activities. About The Role Major accountabilities: Contribute to the development of the long-term PS&PV technology roadmap 2. Be curious and leverage internal and external technologies and opportunities to drive innovation within PS&PV Identify regulatory, market and digitalization trends within and across-industry, and evaluate innovative vendors and technologies in support of the roadmap 4. Execute or contribute to PS&PV level innovation projects in alignment with the roadmap Lead or contribute to major projects as Innovation lead,  Help to identify the right technologies and partners  Bring new technologies to the organization and/or leverage existing tools within Novartis  Help to ensure fast delivery to the business Drive the change management and innovation culture in PS&PV Build trust within the organization and be the innovation partner of choice for business Contribute to PS&PV operational excellence by leveraging process improvements (new technologies, automation, streamlining) to increase quality, efficiency, and productivity Work with internal and external stakeholders to ensure visibility of PS&PV innovation activities Provides project leadership and project management support to key projects. Supports and instills best practices in projects and initiatives by providing tools, training, and resources to project teams. Key Performance Indicators Satisfaction from business and technology stakeholders via feedback Contribution to key enterprise projects with safety relevance Timely, high quality, and within budget delivery of projects and initiatives Broad PS&PV involvement in innovation activities – technology roadmap, Innovation Hub, capability development Visibility of contributions and impact within PS&PV Minimum Requirements 4 - 5 years of PV exp / Life Sciences or Information Technology Fluent in spoken and written English Additional language is an asset Knowledge of systems and regulations – experience with several companies preferred Experience in technology innovation Experience working within IT projects, with a thorough understanding of the issues revolving around aligning technology with business needs Experience in project management Familiarity with modern system and data architecture principles Passion to change the status quo Strong interpersonal and leadership skills Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Their responsibilities include reviewing safety data, identifying potential safety signals, assessing causality, and providing guidance on risk management and communication. Key Responsibilities: Safety Data Review and Analysis Risk Management and Communication Regulatory Compliance Qualifications Bachelor's or Masters degree in a related field, such as Medicine, pharmacy or related field 0-2 years of experience in related field Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/whatsapp to 9342735755

Position - Executive / Senior Executive Department - Corporate Quality Assurance Pharmacovigilance Job Location - Kandivali - West, Mumbai Qualification - M Pharm Experience - 4 - 6 years Job Role: To ensure compliance with SOPs of Corporate Pharmacovigilance cell as well as Corporate Qualifty Assurance To assist Corporate pharmacovigilance cell in overseeing vendor complaince with periodic review and vendor audit To act as a liaison with internal and external auditors and assume responsibility for ensuring corrective actions with their specification To persuade Corporate pharmacovigilance cell staff to adopt and incorporate quality methods in to their work To conduct internal pharmacovigilance audit To perform CAPA management To review change control process, deviation and related QMS documents. The role demands travel for audits at corporate and various plants.

Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets. We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information. Responsibilities: · Contributes to the development & maintenance of product safety profile. · Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products · Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns. · Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients · Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation · Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders · Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis. · Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements. · Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information · Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc · Have thorough medical oversight over the external vendors on the medical review of ICSRs · Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data · Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams · Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc · Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process · Provides inputs to various pharmacovigilance documents like PSMF, SDEA · Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance · Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions · Participates and supports pharmacovigilance audit/inspection preparation and CAPA management · Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners. · Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance. · Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization. · Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc). · Trains and mentors the team members. Other Drug Safety Physician responsibilities include: · Accountable for maintaining personal readiness in response to internal audit or regulatory inspection · Includes knowledge of case processing, expedited reporting and safety database concepts · Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated · Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders · Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities · Strong organisational skills, including capability to prioritise independently with minimal supervision. Qualifications · MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia · Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities. · High degree of professionalism, maturity, business understanding and passion. · Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail · Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making. · Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc) Job Location: Bangalore, India.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below: You will be responsible for : Data Management: Perform duplicate search as per the requirement. Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines. Identify serious adverse events, and special scenario cases which includes lack of efficacy, exposure and pregnancy case, At Risk, and product quality complaint only cases. Ensure scientific rigor through accurate, complete and consistent data entry of adverse events reports from source document with emphasis on timeliness and quality. Data entry of all fields including verbatim as per Client conventions. Responsible for coding which includes adverse events, medical history, Lab data, Indications etc. using standardized terminology from a medical coding dictionary, such as MedDRA. Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. Draft narratives summarizing the essential details of the case. Identify clinically relevant information missing from case report and facilities its collection Perform labeling for Serious/Non-Serious Cases Request for follow-up information by using relevant questionnaire Manage special requests for case processing prioritization (e.g., emails from clients regarding cases that must be processed urgently upon receipt of email notification) Follow standard operating procedures (SOPs) and work instructions related to case processing. Adhere to pharmacovigilance regulations, guidelines, and internal policies to ensure compliance and data integrity. Understanding adverse event reporting requirements and compliance with data privacy regulations is important. Should be open to continuous learning, staying updated with industry changes, new reporting requirements, and emerging safety concerns. Skills: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. Handling of cases in ArisG LSMV safety database ( Mandatory ) Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking Good knowledge on therapy area/medical terminology Good comprehension skills Good communication (verbal and written), with fluency in English and interpersonal skills Your impact: About you: Must have: Attention to detail Good comprehension skills. Good communication (verbal and written), with fluency in English and interpersonal skills. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

As a Clinical Data Services Associate at Accenture, you will play a crucial role in the Clinical Data Management team. Your responsibilities will include collecting, integrating, and ensuring the availability of data at the appropriate quality and cost. You will be involved in activities such as reviewing discrepancies, generating queries, and resolving them. Additionally, you will create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Your expertise will help in identifying and addressing protocol deviations in the database, performing edit check validation, writing test scripts, and conducting database validation (UAT) against specified CRF/ECRF. You will also manage clinical data management projects, ensuring the collection, integration, and availability of data at the required quality and cost to support the conduct, management, and analysis of studies in clinical research. To excel in this role, you should have the ability to establish strong client relationships, handle disputes effectively, manage multiple stakeholders, meet deadlines consistently, and work collaboratively in a team environment. Your role will involve solving routine problems based on established guidelines and seeking guidance from your team and supervisor when needed. You will receive detailed instructions on your daily tasks and new assignments, with the decisions you make impacting your own work within a focused scope. Please be aware that this position may require you to work in rotational shifts. With a Bachelor of Pharmacy or Master of Pharmacy qualification and 1 to 3 years of relevant experience, you will contribute to Accenture's global professional services company. Accenture is known for its expertise in digital, cloud, and security solutions, offering services across various industries to drive value and success for clients worldwide. Join Accenture's Life Sciences R&D vertical, where you will be part of a team dedicated to supporting the world's leading biopharma companies in bringing their vision to life. By converging around the patient and combining scientific expertise with unique insights into the patient experience, you will help improve outcomes and drive innovation in the healthcare sector. Discover a rewarding career at Accenture, where you can leverage your skills in Clinical Data Management to make a meaningful impact on the future of healthcare. Visit www.accenture.com to learn more about our company and explore the opportunities awaiting you in our dynamic and innovative organization.,

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Your role will also include conducting literature screening and review for safety, maintaining drug dictionaries, and ensuring compliance with global drug regulations, Good Clinical Practice (GCP), and ICH guidelines. You will collaborate with internal and external stakeholders to generate expedited safety reports, participate in audits, and apply regulatory intelligence to safety reporting activities. At Syneos Health, we are committed to fostering a culture of diversity and inclusion where every individual feels valued and respected. You will have the opportunity to develop your skills through career advancement opportunities, supportive management, and comprehensive training programs. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. To excel in this role, you should have a strong attention to detail, the ability to work effectively in a team environment, and a commitment to maintaining high standards of quality and compliance. Your contributions will be instrumental in supporting clinical trials and post-marketing programs, ensuring the safety and well-being of patients and enhancing the overall success of our organization. If you are passionate about making a meaningful impact in the field of biopharmaceutical solutions and are eager to collaborate with like-minded professionals, we invite you to explore the exciting opportunities available at Syneos Health. Join us in our mission to transform lives and drive innovation in healthcare. For more information about Syneos Health and our global impact, please visit our website at http://www.syneoshealth.com.,

Kenvue Is Currently Recruiting For A: Manager, , Global Aggregate Reporting and Risk Management What We Do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role Reports To: Associate Director GARRM Team Lead Location: Asia Pacific, India, Maharashtra, Greater Mumbai Work Location: Fully Onsite What You Will Do Kenvue is currently recruiting for: Manager, Global Aggregate Reporting and Risk Management (GARRM) This position reports into the Associate Director, GARRM Team Lead and is based in Mumbai, India. Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role reports to: Associate Director, GARRM Team Lead Location: Mumbai, India Travel %: 10 What You Will Do The Manager, Global Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate reports, Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Manager is an aggregate reporting expert and will have in-depth product knowledge to support daily activities including planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. The Manager provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training, monitors compliance metrics and implements corrective and preventative actions to remediate non-conformance issues. She/he will partner with team members, stakeholders including Global Risk Assessment and Safety Physicians (GRASPs), Qualified Person for Pharmacovigilance (QPPV), Signal Detection and Management (SDM), Global Case Management (GCM), Epidemiology, Regulatory Affairs, Clinical, Medical Affairs, Global PV System Operations (GPSO), Local Pharmacovigilance (LPV), and contracted vendor organizations. Key Responsibilities Ensure timely, quality reports/safety analyses related to core deliverables as appropriate: Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development Provide oversight of staff involved in aggregate reporting Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements Initiate/Conduct/Oversee searches of internal and external databases Perform management review of all vendor-produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review Author, contribute, and coordinate the preparation of core safety deliverables Prepares global aggregate reports for local authorities Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable Partner with vendor to develop reports/deliverables Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements. Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports. Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting. Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures. Develop and maintain systems, tools and processes for drug safety operations. Participate and/or lead cross-functional training of relevant stakeholders and colleagues. Act as product or process Subject Matter Expert (SME) during audits/inspections. Daily management of vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources. Performs training, onboarding, and oversight of offshore vendor. Participate or lead department and/or cross-functional initiatives. Contributes metrics and ensures quality, compliance, and timeliness of aggregate safety reports. Required Qualifications What we are looking for Bachelor’s degree required (health/life sciences field) ≥10 years of experience in the pharmaceutical or related industry with ≥5 years of experience in Pharmacovigilance Proven experience working in matrix environment and cross-functional teams Comprehensive clinical/medical writing experience Strong English verbal and written communication skills Strong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.). Ability to work collaboratively with cross-functional teams. Strong analytical and problem-solving skills. Desired Qualifications Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred Strong leadership and presentation skills. Experience in developing and implementing drug safety policies and operating procedures. Ability to work in a fast-paced environment and manage multiple projects simultaneously. SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management. In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies. What’s In It For You Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! Learning & Development Opportunities Employee Resource Groups This list could vary based on location/region Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Job title : Scientific Sales Executive Location: Delhi Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors Role – Holder Entry Requirements Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharma Relevant Work Experience Minimum Years Of Experience 2+ years of relevant experience Preferred Industry Experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets. Manages and leads a team of professionals in pharmacovigilance and collaborates with IPS Leadership and Heads of Patient Safety in Countries, to ensure an effective model is in place to support PV activities within the scope of IPS HYD. In addition, this role is responsible for leading, overseeing or executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader. Provides leadership and direct line management to IPS team members based in HYD. Contributes to the design and implementation of an effective IPS operating model in HYD to support in-scope PV activities for IPS, spanning multiple geographies and liaising with multiple Heads of Patient Safety, in applicable countries. Collaborates and supports cross-functional teams to ensure effective conduct of PV activities. Leads the ideation and continuous process improvements with the HYD team, to bring incremental business value-add benefit (increase quality, efficiency, consistency) and fully leverages available technology. Leads cultural awareness and ways of working within the HYD team to enable effective ways of working across multiple cultures and geographies. Provides feedback to IPS Leadership on the performance and effectiveness of the IPS operating model in HYD, to ensure its continuous improvement. Addresses any issues or challenges, with clear action plans, on any activity performed within the IPS operating model in HYD. Leads IPS HYD team communications and interactions locally (e.g. team meetings and connections with other PS teams). Leads the planning or contributes to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support/Lead Aggregate Report related activities. Lead the creation/update of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets. Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators. PV activity planning and tracking e.g. signal communications to Health Authorities. Collaborate and support cross-functional teams to ensure effective conduct of PV activities. PV Audit and Inspection support (including preparation, conduct and follow-up actions.) The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required. Functional and Managerial reporting lines into IPS. Excellent interpersonal, verbal, and written communication skills, with the ability to effectively engage across different geographies and cultures. Experience working across cultures and geographies is therefore highly desirable. Solid understanding of pharmaceutical organizations and their structures and pharmacovigilance systems. Able to research, compile and provide safety information in a clear, concise manner. Subject matter expertise in PV legislative matters such as global, regional and any other relevant legislation/guidance regarding PV (e.g., FDA, EMA, ICH, CIOMS). Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines. Utilizes effective problem-solving approaches to address PV issues, leads discussions on process improvement opportunities and co-solutioning with Leadership. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability. Previous line management responsibility, with demonstrable experience in developing talent. Operational Skills Technical Proficiency Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows. Problem-Solving Solves complex problems by reviewing data flows and leveraging digital tools and methods. Process Management Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams. Analytical Skills Data Analysis Uses advanced analytical tools and techniques to interpret and visualize data. Critical Thinking Critically evaluates different options based on evidence and context to form reasoned judgments. Data Management Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality. Strategic Skills Strategic Thinking Integrates a diverse array of digital technologies digital strategies to enhance cross-departmental processes and medium-term PS objectives. Decision-Making Uses multiple data sources and AI generated predictions to support decisions Change Management Drives digital change initiatives, managing stakeholder expectations and overcoming resistance. At least 5 years' experience in the Pharmaceutical Industry, with a minimum of 3 years' experience working in Pharmacovigilance or in a closely aligned field (e.g., Regulatory, Clinical or Medical Information). University degree (health or life science) or nursing qualification. Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency) Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Position Summary The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets. This role is responsible for executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader (or designee). Duties/Responsibilities Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support Aggregate Report related activities. Maintenance of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets. Oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators. PV activity planning and tracking e.g. signal communications to Health Authorities. Collaborate and support cross-functional teams to ensure effective conduct of PV activities. PV Audit and Inspection support (including preparation, conduct and follow-up actions.) The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required. Reporting Relationship Functional and Managerial reporting lines into IPS. Qualifications / Experience Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team. Strong interpersonal, verbal and written communication skills, including the ability to communicate effectively across geographies and cultures, both live interactions and virtually. Able to research, compile and provide safety information in a clear, concise manner. An understanding of local, regional and any other relevant legislation regarding PV (e.g. ICH, CIOMS). Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines. Utilizes effective problem-solving approaches to address PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations. Operational Skills Technical Proficiency Basic use of standard operational software and tools for automation Process Management Understanding of current processes and ability to evaluate and suggest digital improvements. Problem-Solving Addresses straightforward problems with simple digital solutions. Analytical Skills Data Management Processes and records data and information in structured computer readable formats Critical Thinking Identifies flaws and inconsistencies in data or business processes by considering the system wide impact. Data Analysis Can perform basic data gathering and reporting using standard tools. 1-2 years' experience of working in the pharmaceutical industry or a medical environment. Ideally having provided PV or medical/scientific information service in a health care environment. University degree (preferably life science) or nursing qualification. Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency) Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Clinztech is looking for Clinical Data Analyst I to join our dynamic team and embark on a rewarding career journey. Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end - users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Clinztech is looking for Clinical Research Coordinator II to join our dynamic team and embark on a rewarding career journey. Coordinate clinical research activities. Ensure compliance with study protocols and regulations. Recruit and screen study participants. Collect and manage clinical data. Prepare and submit regulatory documents. Monitor study progress and report findings. Liaise with research teams and sponsors.

Clinztech is looking for Pharmacovigilance Associate I to join our dynamic team and embark on a rewarding career journey. Monitor and assess the safety of pharmaceutical products through the collection and analysis of adverse event reports. Ensure compliance with regulatory requirements related to pharmacovigilance. Prepare and submit reports to regulatory authorities regarding product safety. Collaborate with internal teams to develop risk management strategies for pharmaceutical products. Provide training and guidance to staff on pharmacovigilance practices and policies. Maintain up - to - date knowledge of industry trends and regulatory changes.

working knowledge on Farefiling/ PRA/ CRA/ GDS/ Amadeus/Galileo platform will be an added advantage. Experience in booking reservations, cancellation of reservations, fare calculations will be added advantage. Candidate with IATA course/certification will be preferred. Candidate should be able to maintain the highest level of quality and achieving team targets as per the process specifications. IATA Fresher’s can apply. Experience in travel background of minimum 1 years will be added advantage Candidate should be comfortable with rotational shift including night shifts Walk in for an interview between Monday to Friday at 12.00 pm to 4.00 pm at WNS,Gate no 2,Plant 5, Vikhroli west Qualifications Any Graduate and Under Graduate Additional Information Night Shifts/Rotational Shifts

Sunflower WomenS Endo Infertility And Hospital Pvt. Ltd. is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Clinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningOracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)C, C++, C# Programming SkillsExperience in writing programs using Javascript Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech