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0.0 - 2.0 years

2 - 4 Lacs

Puducherry, Chennai, Vellore

Work from Office

Medical Coding is the process of converting Medical Records into numeric or alpha numeric by using ICD 10-CM, CPT & HCPCS Hr Priya -9600450980 Designation - Medical Coder Trainee Profile UG /PG in Allied Health Science , Life Science, Paramedical, Required Candidate profile Required Candidate profile Nursing Freshers Pharmacy Freshers Physiotherapy Physician Assistant Critical Care Optometry OT & AT Radiology Dialysis Technology MLT Cardiac Technology Emergency Care Perks and benefits Incentive Up to 5k Insurance Provident Fund

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2.0 - 6.0 years

0 Lacs

hyderabad, telangana

On-site

As an Associate Regulatory Affairs, your primary role will be to assist in obtaining and maintaining regulatory approvals for beauty, health, wellness, cosmetics, and food products. It is crucial to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. Your responsibilities will include preparing dossiers that are country and category-specific for domestic and international markets to ensure error-free and timely submissions according to department timelines. You will be responsible for coordinating with suppliers and vendors to maintain product master data. Additionally, you will review, prepare, submit, and coordinate with relevant regulatory bodies across countries. Resolving deficiencies and queries from customers, partners, and regulatory agencies will also be part of your role. You will assist in the development of Regulatory Affairs Standard Operating Procedures (SOPs) and ensure adherence to internal audit requirements as per Quality Management System (QMS) standards. Participating in risk-benefit analysis for regulatory compliance and identifying, planning, and implementing process improvement initiatives are also key aspects of your responsibilities. To qualify for this role, you must hold a graduate degree in Science, Engineering, or Pharmacy. A minimum of 2 years of experience in global regulatory requirements of products, processes, and procedures is required. Experience in product compliance or product stewardship is preferred. You should be able to work independently without supervision and communicate effectively, both in writing and orally, with technical and non-technical colleagues. As a problem solver, you should be able to identify issues, review related information, develop and evaluate options, and implement effective solutions. Managing parallel projects and sometimes competing deliverables to meet project delivery dates will also be part of your job scope.,

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1.0 - 3.0 years

1 - 3 Lacs

Bengaluru

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We're Hiring: Retail Pharmacists Location: Bangalore, Hyderabad, Chennai, Dehradun Industry: Healthcare & Pharmacy To Apply visit our career page Who Can Apply Bachelor of Pharmacy (B.Pharm) To Apply visit our career page Provident fund Sales incentives House rent allowance

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3.0 - 6.0 years

20 - 25 Lacs

Hyderabad

Work from Office

Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. About the Role Key Responsibilities Structured Data Submissions (SDS): Independently perform timely SDS (e. g. xEVMPD, IDMP) via RIM system, ensuring data quality and exchange with EMA including analysis and tracking of 3rd acknowledgements. Ensure Data Quality Management and timely delivery of requests for new/changes of code lists/terms including external reference data (e. g. SPOR). Provide guidance and support to cross-functional teams related to planning, submission compilation and dispatch of worldwide compliant SDS, as well as submission filing strategy, eCTD document lifecycle management and workflows, in alignment with FHIR (Fast Healthcare Interoperability Resources). Assess SDS resources and support needs and develop/implement solutions to create efficiencies. Effectively troubleshoot technical/quality issues relating to compilation, validation and dispatch of global submission outputs. Coding of Clinical Particulars: Perform coding of the Clinical Particulars attributes in Novartis Regulatory Information Management (RIM) system: Therapeutic Indications and Co-morbidity using the MedDRA dictionary, Intended effect using a controlled vocabulary, as required to ensure compliance with xEVMPD / IDMP requirements. Review and maintain MedDRA code values used in EU registrations upon MedDRA version updates by performing gap analysis of changes, and update existing values accordingly in RIM system. Review and update coding values as needed upon queries from the European Medicines Agency (EMA), for instance receipt of 3rd acknowledgment. Interactions: Liaise with GDD colleagues regarding new regulatory requirements and related business processes, to ensure proper knowledge transfer to IT business partners for system enhancement requests. Manage interactions and collaboration with RA Country Organisations (CO), Global RA and non-RA functions on regulatory and compliance maintenance activities for Authorised and Investigational medicinal products. Optimally support QPPV and PV-related processes (incl. fees), provide support for internal /external audits /inspections. Facilitate and/or participate in meetings with internal and external stakeholders (including acquisitions, partnerships and divestiture efforts). Participate as key business contributor in Technology initiatives including, but not limited to, systems upgrades, validation, implementation activities and functionality enhancements, including external service providers. General & Training: Support user training of RA end users, as required, Coach / mentor new team members. Support PQ testing and Application verification activities, as required. Support preparation of administrative procedures and Working Instructions to support system implementations. Develop, implement, and support innovative regulatory strategies and life-cycle management of RA systems, including process productivity and efficiency improvement and propose potential solutions. Identify and investigate operational needs, problems, and opportunities, contribute to the implementation of improvements within area of responsibility. Minimum requirements BS in Life Sciences (Medicines/Pharmacy) or a relevant discipline with at least 7 years of professional work experience. Master s degree preferred (M. Pharma or MD). 4-6 years of relevant experience in structured data submissions (e. g. xEVMPD) and use of RIM systems, including familiarity with submission publishing activities. 3-5 years in Clinical coding (e. g. MedDRA, SNOMED), Labelling, Regulatory Affairs or Regulatory submission related experience. WITH SDS experience as 1st bullet, Proficient knowledge of EMAs databases (e. g. SPOR). Knowledge and experience with eCTD, xEVMPD, IDMP, Publishing Standards and applicable related tools is desirable. Experienced in using RA systems of data (RIMS, DMS, Change Control databases), systems data model and vocabularies. Familiar with the drug development and registration process. Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously. Familiar with global Health Authority regulations/guidelines e. g. , FDA regulations, ICH and EMA guidelines/directives. Proficiency with computer programs/systems (MS office, etc. ) with demonstrated ability to learn new systems quickly. Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change 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:

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5.0 - 14.0 years

20 - 25 Lacs

Hyderabad

Work from Office

Summary The Global Change Control Manager oversees the entire process of managing GxP-impacting changes within the global manufacturing network. This role is responsible for the change control process from initiation, through impact assessment, planning, execution tracking, documentation, CAPA effectiveness, continuous improvement in change governance, and metrics reporting. The manager works closely with cross-functional teams such as Regulatory, Quality, Operations, to support timely implementation, risk management, and ongoing improvement in change governance. The role also contributes to audits, inspections as well. About the Role Key Responsibilities: Good Understanding of Global Change control process and able to advice on Global and Local Change request strategy. Align between sites and Regulatory team regarding Change control plan, impact / implementation on sites. Prepare the change request plans and present them for endorsement at the Change review board (CRB) Open global change requests, assign impact assessment actions, and manage the lifecycle of Change Requests (CR). Track and report the implementation status of change requests with cross-functional teams. Manage and maintain change control documentation, including updates, version control, and compliance with cGMP and regulatory standards. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Collaborate with cross-functional teams (Quality, Operations, Engineering) for accurate documentation. Track and report metrics related to documentation timeliness, compliance, and quality. Comply with internal processes like KPI reporting, ticket management, and functional requirements. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Support and contribute to quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable. Good Understanding of Process/Cleaning Validation and Technology transfer concepts and requirements including transfer protocols, validation protocols & reporting and comparability reports Collaborate with site teams for Transport Validation / Shipping verification activities including validation risk assessment, testing protocols and reports. Act as SPOC to drive key Global projects within the platform and collaborate with sites to ensure timely execution of tasks/ deliverables Desirable Requirements: Bachelors/Master degree in Pharmacy, Pharmaceutical Technology, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Good understanding of Radio Ligand Therapies (RLT) platform Minimum 10 years of experience in MS&T, Quality Assurance in Manufacturing of Biologics Drug substance and Drug Product. Hands on experience in 1-QEM tool. Strong understanding of Global change control processes, cGMP, and regulatory requirements Proven project management experience in a cross-functional environment (e. g. multi-site, technical development, other functions). PMP is added advantage. Expertise in document management system and writing technical reports Experience in Health authority audits and Self inspections. Good communication, presentation and Interpersonal skills. Proficiency in English (oral and written) is mandatory. Essential Requirements: Quality / Accuracy / Right First Time Quality System Management (Change Control, CAPA, Risk Assessment and EC) Support Accuracy and compliance of change control documentation Timeliness of documentation updates and approvals Stakeholder satisfaction with documentation quality and usability Adherence to regulatory requirements during audits and inspections Effectiveness of standardized documentation processes Skills: Change Control Process Effective communicator Strong cross functional collaboration Biologics Manufacturing Process Project Management Good Documentation Practice Effective stakeholder engagement Report writing Knowledge Of GMP (Good Manufacturing Practices) Deviation management Corrective and preventive action (CAPA) General HSE Knowledge Manufacturing (Production) Manufacturing Technologies. Process And Cleaning Validation Why Novartis: Commitment to Diversity and Inclusion: . 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:

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0.0 - 4.0 years

1 - 4 Lacs

Kolkata

Work from Office

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

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10.0 - 15.0 years

3 - 7 Lacs

Surat

Work from Office

ROLES & RESPONSIBILITY Oversee the daily operations of the raw material store, ensuring proper storage, labeling, and handling practices are followed. Maintain accurate inventory records of all raw materials, including batch numbers, expiry dates, and storage conditions. Supervise the receipt of incoming raw materials, ensuring quality checks, GRN generation, and documentation are completed. Ensure materials are stored as per predefined environmental and safety standards (e.g., temperature, humidity, segregation). Coordinate with the Quality Control (QC) and Quality Assurance (QA) departments for material clearance and release for production. Implement FIFO/FEFO principles and monitor stock movement to prevent material expiry or obsolescence. Conduct regular cycle counts and support full physical stock audits. Maintain documentation in compliance with ISO 13485, GMP, and company SOPs. Ensure timely issuance of materials to production based on requisitions and maintain issue records. Train and supervise store personnel, ensuring adherence to company procedures and safety protocols. Coordinate with procurement and planning teams for material availability and shortage alerts. Manage store cleanliness, pest control activities, and overall hygiene as per QMS requirements. Qualifications and Skills: Bachelor s degree in Science, Pharmacy, Supply Chain, or related field (preferred). 10+ years of experience in inventory/store management in a manufacturing or medical device company. Strong knowledge of material handling, warehousing systems, and ERP software. Familiarity with ISO 13485, GMP, and regulatory requirements related to raw material handling. Excellent organizational, communication, and problem-solving skills. Attention to detail and commitment to documentation accuracy. Key Competencies: Inventory Management Regulatory Compliance Documentation Accuracy ERP and Barcode Systems Team Management Coordination & Communication Quality Awareness Problem Solving

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0.0 - 3.0 years

2 - 3 Lacs

Kolhapur

Work from Office

To promote the company products to doctors To achieve sales target Meet the Stockiest, make the products availability, Chemist survey for better marketing Manage sales & mktg operations with focus sales growth

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0.0 - 3.0 years

5 - 8 Lacs

Kozhikode

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Aster Medcity is looking for Specialist.Emergency Medical Services to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field

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0.0 - 3.0 years

9 - 13 Lacs

Bengaluru

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Aster Medcity is looking for Consultant.Anaesthesiology.Aster RV Hospital to join our dynamic team and embark on a rewarding career journey Undertake short-term or long-term projects to address a variety of issues and needs Meet with management or appropriate staff to understand their requirements Use interviews, surveys etc. to collect necessary data Conduct situational and data analysis to identify and understand a problem or issue Present and explain findings to appropriate executives Provide advice or suggestions for improvement according to objectives Formulate plans to implement recommendations and overcome objections Arrange for or provide training to people affected by change Evaluate the situation periodically and make adjustments when needed Replenish knowledge of industry, products and field

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0.0 - 2.0 years

2 - 4 Lacs

Kannur

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Aster Medcity is looking for Junior Pharmacist.Pharmacy 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.

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8.0 - 16.0 years

25 - 30 Lacs

Mumbai

Work from Office

Specialist Regulatory Affairs LCM - Strategic Growth Products Date: 14 Jul 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Location: Andheri, Mumbai (Hybrid working opportunity) About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About Business Unit The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. What You ll Do: Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through MA will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Formal training in Regulatory Knowledge, Skills Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Medical writing and Review experience Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. Why ADVANZ PHARMA The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you ll be empowered to own your work, explore new possibilities, and make things happen. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

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8.0 - 16.0 years

25 - 30 Lacs

Mumbai

Work from Office

Select with space bar to view the full contents of the job information. Specialist Regulatory Affairs LCM - Strategic Growth Products Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Specialist Regulatory Affairs LCM - Strategic Growth Products ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM for Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars and Specialty Generics that would require significant technical inputs on CMC and Clinical side during post approval phase. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Notification of Change in Marketing Status, sunset clause exemptions where applicable Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Biosimilars (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Proven Biosimilars regulatory experience for EU preferably Life cycle activities. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines or/and complex CMC post approval changes. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data centre "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another

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0.0 - 8.0 years

5 - 6 Lacs

Mumbai

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Previous job Next job JOB DESCRIPTION Mumbai Job Description Generate sales through close and regular interaction with assigned customers, such as healthcare practitioner (HCPs) and by developing new projects that meet sales objectives Make calls on existing or potential customers such as healthcare practitioner (HCPs) and serve as representative of the Company in all matters concerning product and service delivery Keep abreast of new products or services and other general information of interest to customers while continuously upgrading ones product knowledge and selling techniques Transform information captured from the field/shoppers and from interactions with customers/external partners to insights for developing programs and plans that will further build the business Job Qualifications Minimum Bachelor s degree required. B. Pharm or Science graduates preferred Experience and/or training in chain pharmacy, specifically in Field Sales, Pharma sales and Sales Management in the Pharmaceutical industry, preferred.

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2.0 - 7.0 years

3 - 16 Lacs

Pune

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CORE JOB RESPONSIBILITIES 1. To analyse and prepare working plan for the territory basis the data provides/ market research 2. To be able to follow up, monitor and achieve targets of the territory 3. Implementation & execution of all strategies 4. Stakeholder engagement- doctors, stockist, retailers, chemists and institutions pharmacy 5. Discipline and punctual with set timelines for multiple internal processes 7. Basic computer skills- excel working, word & email exchanges 6. Fast learner and adaptable to change in market 7. Strong communication skills (verbal)- English and local language 8. Effective in-clinic performance 9. Basic understanding and ability to explain anatomy physiology and product portfoli0 10. Organizing Camps (CME) as per the division strategy and customer needs 11. Prescription audit for Abbott brands and other competitors brands 12. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider Required Qualification B.Sc. / B.Pharma. LOCATION: India > Pune : Tara Heights, CTS No.20/2, Final Plot, no.18/2 t

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5.0 - 8.0 years

50 - 55 Lacs

Noida

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Company: Mercer Description: Mercer is seeking candidates for the following position based in their Noida / GGN Office This is a hybrid role that has a requirement of working at least three days a week in the office. This is an IC (Individual contributor) role Senior Manager H&B Consulting - Group Benefits Underwriting What can you expect Mercer is seeking a Senior Health Benefits Analyst to join our team servicing US/Canada regions. This position is a part of a team that provides comprehensive group benefits and human resources solutions to client organizations. The work involves performing data analysis/audit/reconciliation activities and assisting with creating reports.In this critical & analytical role, you will apply your knowledge of functional and technical requirements in conjunction with client business requirements. We will count on you to Create experience reports by gathering necessary data and reviewing it to ensure it is complete, accurate and reasonable Prepare and send templated experience reports to local teams within agreed upon timelines Collect and review vendor renewal data for accuracy and reasonableness Analyze renewal proposals and arrive at a suggested negotiated position for client teams Prepare templated client renewal reports to cascade to local consulting teams Collect and review financial statements for accuracy and reasonableness Prepare a templated financial statement report for client teams Technical peer review other teammates work to ensure accuracy Assist in keeping workflow tracking tool up to date Assist in development and evolution of tools and templates used for workflow, experience reports, financial summaries and renewals to gain efficiencies and streamline work What you need to have: Graduate with minimum 5 - 8 years relevant experience (in group benefits underwriting or benefits consulting, not benefits administration) Intermediate to advanced level knowledge in MS Excel (Must) Proficiency with MS PowerPoint Strong experience in Project/Process/Task Requirements & translating requirements into working deliverables Excel VBA/Python and PowerBi (Preferred- Good to have) Knowledge of H&B domain (Preferred) Sound knowledge of process documentation, development of SOP, knowledge artifacts Ability to work independently and on a team Advanced Logical, Data Analytical & Data Mining skills Strong experience in Workflow, RCA, Defect Management Project management skills thorough understanding of projects and processes Excellent interpersonal skills, strong oral & written communication skills Ability to prioritize and handle multiple tasks in a demanding work environment Applicants should be flexible working in shifts What makes you stand out Adaptable communicator, facilitator, influencer and problem solver High attention to detail Good relationship skills, Proven ability to work on own initiative as well as in a team Ability to multi-task and prioritize time effectively Master s in Business Administration (MBA) Pharmacy benefit management experience Understanding of the US healthcare industry, including pharmacy claim payment systems Project management certifications Mercer believes in building brighter futures by redefining the world of work, reshaping retirement and investment outcomes, and unlocking real health and well-being. Mercer s more than 20,000 employees are based in 43 countries and the firm operates in over 130 countries. Mercer is a business of Marsh McLennan (NYSE: MMC), the world s leading professional services firm in the areas of risk, strategy and people, with more than 85,000 colleagues and annual revenue of over $23 billion. Through its market-leading businesses including Marsh, Guy Carpenter and Oliver Wyman, Marsh McLennan helps clients navigate an increasingly dynamic and complex environment. For more information, visit mercer.com. Follow Mercer on LinkedIn and X. Marsh McLennan is committed to embracing a diverse, inclusive and flexible work environment. We aim to attract and retain the best people and embrace diversity of age, background, caste, disability, ethnic origin, family duties, gender orientation or expression, gender reassignment, marital status, nationality, parental status, personal or social status, political affiliation, race, religion and beliefs, sex/gender, sexual orientation or expression, skin color, or any other characteristic protected by applicable law. Marsh McLennan is committed to hybrid work, which includes the flexibility of working remotely and the collaboration, connections and professional development benefits of working together in the office. All Marsh McLennan colleagues are expected to be in their local office or working onsite with clients at least three days per week. Office-based teams will identify at least one anchor day per week on which their full team will be together in person.

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12.0 - 15.0 years

11 - 16 Lacs

Bengaluru

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About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures. Job Responsibilities Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation. Approval of layouts, yearly & monthly schedules, to be added planners. SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements. Assess change controls related facility, equipment, process, utility, cleaning and packaging. Review & approve of standard operating procedures. Co-ordination and implementation of training activities of team members. Responsible for review of site VMP s (Validation Master Plan) and related documents. Responsible for review and approval of process validation & cleaning validation protcolsand reports. Co-ordinate with cross functional teams in Investigations carried out at ARPL. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned as per the expertise in the relevant subject. Job Requirements Education Minimum Bachelor of Pharmacy/ Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning Maintains good Interpersonal skills and communication skills. Strives to drive projects related to Validations & Engineering effectively. Experience Minimum 12 - 15 years of experience in GMP Regulated pharmaceutical industry At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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8.0 - 12.0 years

8 - 13 Lacs

Bengaluru

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About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner. Job Responsibilities Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA s) and Temporary change controls. Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance. Review of standard operating procedures. Assessment and approval of change controls. Review and approval of instrument qualification and calibtration documents in timely manner. Review and approval of method transfer and validation protocols/ reports. Review and approval of specifications and MOA. Provide support to self inspections and audits by regulatory authorities / third parties as required. Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements. Provide training as required. Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to: Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties. Providing coaching, feedback and recognition. Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values. Communicate corporate vision and goals to direct reports in an effective and efficient manner. All other duties as assigned. Job Requirements Education Minimum Bachelor of Pharmacy / Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR s Hands on experience in Trackwise application, LIMS and Empower application. Maintains good interpersonal skills and communication skills. Knowledge on method transfer and validation activities. Experience Minimum 8-12 years of experience in GMP regulated pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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7.0 - 12.0 years

12 - 20 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

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Work with management and key decision makers to generate leads and convert the same to firm orders Providing product demonstrations to potential customers Support after sales requirements Seek service opportunities and convert to orders

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1.0 - 6.0 years

3 - 8 Lacs

Visakhapatnam

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Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy. What You Will Achieve In this role, you will: Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records. Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories. Perform testing on various samples, manage Laboratory Information Management System builds. Serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and train junior colleagues. Here Is What You Need (Minimum Requirements) Batchlor of Science/ Pharmacy or Master of science / pharmacy with 1 to 6 years of quality control experience Strong technical skills chemical quality testing Detail-oriented with robust knowledge of quality control process Familiarity with analytical laboratory equipments like HPLC, GC, AAS,ICP-MS, UV, IR and etc., Effective written and verbal communication, as well as interpersonal skills Bonus Points If You Have (Preferred Requirements) Relevant pharmaceutical experience Experience with Laboratory Information Management Systems (LIMS) Knowledge of regulatory requirements and guidelines Strong problem-solving abilities Effective time management and organizational skills Ability to mentor and train junior colleagues Work Location Assignment: On Premise Quality Assurance and Control #LI-PFE

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3.0 - 8.0 years

1 - 5 Lacs

Noida

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We at Kailash Group of Hospitals is urgently hiring for Marketing Representative for Sector 27, Noida Should have experience into Pharma Sector marketing Education- Graduation/Post Graduation Contact- 8585904929 Email- resume@kailashhealthcare.com

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3.0 - 8.0 years

1 - 5 Lacs

Noida

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We at Kailash Group of Hospitals is urgently hiring for Medical Representative for Sector 27, Noida Should have experience into Pharma Sector marketing Education- Graduation/Post Graduation Contact- 8585904929 Email- resume@kailashhealthcare.com

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10.0 - 15.0 years

7 - 12 Lacs

Banur

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Leadership & Strategy Provide leadership and direction for all pharmacy services and staff. Develop and implement departmental goals aligned with organizational strategy. Promote a culture of safety, excellence, and continuous improvement. Clinical Governance & Compliance Ensure adherence to national and institutional regulations (e.g., FDA, MHRA, GPhC, NABH). Oversee medication safety, formulary management, and pharmacovigilance programs. Lead audits, quality assurance initiatives, and risk mitigation strategies. Operational Management Oversee procurement, inventory, and distribution of medications. Optimize pharmacy workflows, staffing, and use of technology. Ensure availability of essential drugs and rational drug use. Financial & Resource Management Develop and manage department budgets. Monitor drug expenditure and implement cost-control measures. Lead contract negotiations with suppliers and vendors. Education & Research (if in an academic or teaching hospital setting) Supervise and mentor pharmacy staff, students, and residents. Oversee continuing education and professional development programs. Facilitate academic teaching, curriculum development, and research initiatives. Collaboration & Communication Liaise with clinicians, nursing, and administrative departments to ensure integrated care. Serve as the departments representative in institutional committees and external bodies. Engage patients and stakeholders in medication-related education and decisions.

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0.0 - 5.0 years

2 - 4 Lacs

Nashik, Igatpuri

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Job description Is responsible for overall store operations. He / She will have to manage the allocated shift (opening / closing). Ensure compliance to set standards and control short excess. Will be responsible to ensure all mandatory Licenses are in place. He / She will be responsible for the following: Buying: Responsible for availability, sourcing and negotiation of product and price. This role requires very good product knowledge. Key Responsibilities: Responsible for the entire buying cycle from Manufacturers/ Distributors Co ordination with Managers Vendor Sourcing & Vendor management. Ensure FIFO and expiry check Prepare reports and analyze data as and when required GRN: Responsible for accurately and efficiently recording the receipt of goods into the company's inventory system. Key Responsibilities: Process goods receipt transactions in SAP Ensure accurate and timely entry of GRN data, including quantities, prices, batch no, expiry date and other relevant information. Verify and reconcile GRN data with purchase orders and other supporting invoices. Identify and resolve any discrepancies related to GRN entries to control pilferage and avoid short excess. Reconcile GRN data with inventory records and financial transactions. Communicate effectively with internal departments (e.g., procurement, finance, warehouse) regarding GRN-related issues Ensure FIFO and expiry check Prepare reports on GRN activities as required. Receiving: Responsible for efficient Receiving, storage, and movement of goods within the warehouse. Key Responsibilities: Ensure accurate inventory levels and timely fulfillment of store orders by regular checks. Receive ordered stocks, verify quantities and conditions against purchase orders, FIFO, checking expiry, batch no's, etc. Inspect goods for any damage or discrepancies. Maintain accurate registers and inventory records. Conduct physical inventory checks to tally records. Operations: Will be responsible for day to day operations. Key Responsibilities: Dispense medicines as per prescriptions Placement of medicines in the right locations Prepare accurate invoices and ensure proper recording of transactions. Counsel and guide customers as and when required. Manager customer grievances and escalations. Ensure FIFO and expiry check accurate receipts and payments Ensure all processes and all compliances are followed as per the Law. Maintain store hygiene and cleaning. Responsible for maintenance and upkeep of data. Role & responsibilities. Role & responsibilities

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0.0 - 1.0 years

2 - 3 Lacs

Hyderabad/Secunderabad, Pune, Bengaluru

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Should have knowledge in Clinical Data Management Should have good knowledge in edit checks crf design SAE Reconcilation crf annotation Clinical Data Management Trained Candidates Only Eligible Required Candidate profile Strong understanding of clinical data management and E2b Guidelines Excellent clinical assessment and Communication Skills

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