410 Drug Safety Jobs - Page 2

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

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

: Prepare and maintain the Signal Schedule as per Standard Operating Procedures. Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. Impart trainings related to Signal Management activities, as and when required Skills Required: Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced

Education - PhD, MD, BDS, MDS, with specialization in Medical Genetics, Molecular Biology, Genomics, or related fields. Who are we HaystackAnalytics is a HealthTech company creating clinical genomics products, which enable diagnostic labs and hospitals to offer accurate and personalized diagnostics. Supported by India's most respected science agencies (DST, BIRAC, DBT), we created and launched a portfolio of products to offer genomics in infectious diseases. Our genomics based diagnostic solution for Tuberculosis was recognized as one of top innovations supported by BIRAC in the past 10 years, and was launched by the Prime Minister of India in the BIRAC Showcase event in Delhi, 2022. Key Responsibilities Scientific Engagement & Field Support Build and maintain strong relationships with KOLs and HCPs in the fields of medical genetics, genomics, reproductive medicine, oncology, and other relevant specialties. Work closely with the sales team. Present scientific and clinical data accurately. Serve as the primary scientific contact for inquiries related to genetics-based products and services. Participate in scientific advisory boards, conferences, and symposia as a representative of the medical/scientific team. Medical Affairs & Education Support the development and delivery of scientific training programs for internal teams (sales, marketing, customer support). Conduct educational sessions, CMEs, and academic presentations for external stakeholders. Assist in the creation and review of medical/clinical content, including white papers, presentations, and medical communication materials. Clinical Support & Insights Provide scientific support for clinical trials, real-world evidence projects, and post-marketing studies. Collect and report medical insights from the field to help guide product development and marketing strategy. Support clinicians with test interpretation, report explanation, and phenotype-genotype correlation where needed. Compliance & Documentation Ensure all activities comply with applicable regulatory, ethical, and legal guidelines. Maintain up-to-date knowledge of relevant literature, genetic technologies, and clinical guidelines (e.g., ACMG, ESHG). Qualifications PhD, MD, BDS, MDS, with specialization in Medical Genetics, Molecular Biology, Genomics, or related fields. Key Competencies Strong communication and presentation skills for both technical and non-technical audiences. Strategic thinking with the ability to align field activities to company goals. Ability to work independently and collaboratively in a cross-functional environment. Willingness to travel Pan India

Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product. The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Let s do this. Let s change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology. This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead. Key Activities Provide direction, strategy and leadership for signal detection and management activities at the India site Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals. Regular communication with the global team to discuss product and/or process issues. Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff Ensure staff are compliant with Amgen corporate and departmental training Disseminate relevant information to teams as appropriate Ensures smooth and collaborative interactions with all other Safety groups Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS Accountable for delivery against goals assigned to group Participate in budget and headcount planning Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 3 years of functional management experience overseeing PV staff A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective Leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources 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, we ll 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.

Let s do this. Let s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) 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, we ll 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.

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Job Summary: Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases. Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Responsible for raise of device/combination product case related issues. Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products. Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness. May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable. Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor. Key Activities: Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Ensures compliance and timely reporting with device/combination product cases through query process. Contributes to the implementation of new intake-related systems, processes and procedures within the process. Supports an engaging culture. Ensures quality of PC, AE and OSF records. Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems. Implements Standard Operating Procedure requirements for device/combination product cases. Develops solutions to technical problems up to moderate complexity. Knowledge and Skills: Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). Familiarity with clinical development process. Demonstrating high case level productivity and quality. Attention to detail. Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Master s degree and 7 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 9 years of Drug Safety or Life Sciences experience. Education & Experience (Preferred): Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry. Bachelor s Degree in a health-care subject area or scientific field. Previous experience with a corporate intake system or safety database. Ability to successfully manage workload to strict timelines. Familiarity with basic project management tools. Demonstrated ability to consistently deliver on-time, and high-quality results. Ability to operate in a matrixed or team environment. Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). 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, we ll 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.

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

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment. Review and respond to any queries/comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers. Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service. Maintain good knowledge of databases, regulations, guidelines and SOP s. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs. Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes. Perform any other drug safety related activities as assigned. . Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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.

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. 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We are hiring!! Open Position : Drug Safety Associate - 1, with a minimum of 1 year experience in case processing. Location : Initially work from home, later will be office based Salary Upto : 4 Lakhs INR per annum Qualifications: Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Roles and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Drug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar with regulatory &pharmacovigilance guidelines. Should be familiar with pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Additional Skills Strong motivational skills and abilities, promoting a team-based approach. Strong interpersonal and communication skills, both verbal and written. Strong organizational and leadership skills. Goal-oriente and ability to maintain professional and positive attitude.

We are currently hiring for DSA I role with a minimum of 1 year experience in case processing. Location : Hybrid Salary Upto : 4 Lakhs INR per annum Essential Duties and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Dug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar with regulatory &pharmacovigilance guidelines. Should be familiar with pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Other skills: The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Qualifications Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Additional Skills Strong motivational skills and abilities, promoting a team-based approach Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal-oriented Ability to maintain professional and positive attitude

We are looking for a skilled OT Technician to join our team at Raigad Hospital and Research Centre. The ideal candidate will have 1-6 years of experience in the field. Roles and Responsibility Assist surgeons during surgical procedures and ensure patient safety. Prepare and maintain operating room equipment and instruments for surgery. Monitor patient vital signs and respond to emergencies. Maintain accurate records of patient information and medical history. Collaborate with other healthcare professionals to provide comprehensive care. Participate in ongoing education and training to stay updated on latest techniques and technologies. Job Requirements Strong knowledge of medical terminology and anatomy. Ability to work effectively in a fast-paced environment and prioritize tasks. Excellent communication and interpersonal skills. Ability to maintain confidentiality and handle sensitive information. Familiarity with hospital policies and procedures. Commitment to delivering high-quality patient care and services.

MedeXCode is looking for Junior Pharmacovigilance Specialist 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

We are looking for an experienced and dedicated Clinical Pharmacist to join our team The candidate should have a minimum of 1 year of experience Review and evaluate medication orders to ensure appropriateness, safety, and efficacy based on patient-specific factors such as age, condition, and comorbidities Collaborate with physicians, nurses, and other healthcare professionals to develop and implement patient-specific medication therapy plans Monitor patient progress and outcomes to adjust medications as needed Educate patients and caregivers on the proper use, side effects, and interactions of prescribed medications Ensure compliance with established protocols, regulatory requirements, and hospital policies Conduct medication reconciliation during patient transitions of care Participate in clinical rounds and provide drug information and therapeutic recommendations to healthcare teams Maintain accurate and updated patient medication records Assist in formulary management and participate in drug utilization reviews and audits Provide training and guidance to pharmacy staff, students, or residents Ask ChatGPT

Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Senior Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 5 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.

Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 3 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.

Department New Generation Insulin (NGI) The Position As a Regional Medical Advisor, you will contribute actively to medico-marketing activities in the business area/portfolio and support in implementation of the Medical Affairs strategy in the country. You will be responsible for: Executing the Indian medical strategy into local activities in your designated region Building, maintaining, and nurturing the excellent scientific relationship with all the key influencers and stakeholders Training and educational activities for Physicians and other Health Care Professionals (HCPs) working with diabetes and obesity Medical support to brand team You will also be responsible for: To assist the marketing and sales team in sharpening and positioning product and promotional strategies. Foresee the challenges as well as changing market dynamics and make timely corrective and preventive actions. You will stay updated on scientific knowledge by actively participating in scientific meetings, gathering clinical insights/needs/feedback from key opinion leaders, and communicating with internal stakeholders. Responsible for educating and training the field and marketing personnel and other relevant stakeholders regarding all aspects of disease, product, and therapy relevant to promotional strategy. You will build a strong advocacy of Novo Nordisks portfolio with key external stakeholders through ongoing/robust scientific interactions. Qualifications MBBS/ MD in Pharmacology from a reputed institution. You shall have strong scientific knowledge and interest in diabetes and obesity including both the therapy area and the products, good collaboration with internal and external stakeholders as well as good communication and negotiation. Strong analytical capabilities, with demonstrated experience in analyzing complex situations. Skills for planning, execution, and follow-up are required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence and strive towards working with both operational as well as more judicious tasks.

Job Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience: 1-3 Years.

We are seeking a highly detail-oriented MedDRA Coder to support our Drug Safety and Pharmacovigilance operations. The ideal candidate will be responsible for the accurate and consistent coding of adverse event terms using MedDR , ensuring compliance with regulatory and quality standards. Roles and Responsibilities Code Adverse Event terms using MedDRA for clinical trials, post-marketing safety reports, and spontaneous reports. Ensure consistency and accuracy in medical terminology coding across safety databases. Collaborate with safety physicians, case processors, and medical reviewers to ensure appropriate interpretation and classification. Maintain knowledge of current MedDRA updates and implement changes into the safety database. Perform quality checks and reconciliation of coded data. Support regulatory submissions by ensuring properly coded safety data. Participate in coding conventions , coding guideline development, and audit preparedness. Qualifications Bachelors degree in Life Sciences, Pharmacy, Nursing, or related field. 1-3 years of experience in drug safety coding using MedDRA Knowledge of global regulatory guidelines. Excellent communication and attention to detail. Interested to apply can share CV or call/WhatsApp to 9342735755

Summary The Medical Expert in TCO (Translational Clinical Oncology) is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical co-leadership for assigned aspects of one or more global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) leading the program. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. May represents CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits. Oversees the clinical/scientific elements of TCO related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc. Leads the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Manages stakeholder engagements internally and externally Mentors and coaches junior TCO team members in India Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India Advocate continuous improvement of quality Ensure all activities of associates comply with company standards and local regulations Key performance indicators: Management of assigned studies to ensure execution according to timelines, and with high quality, ensuring adherence to international and local regulations. Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents. Strong evidence of quality medical review of trial data and quality contributions to clinical sections of e.g. protocols, IBs, DSURs and CSRs Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: Education: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required. Experience in hematology / oncology preferred Work Experience: At least 5 years of pharmaceutical/biotech industry experience At least 2 years of clinical practice experience in the hospital setting. Experience with oncology clinical trials Experience with early development clinical trials Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects. Strategic thinking: ability to network with and influence key stakeholders, clear and logical presentation of complex strategic issues. Clear written and verbal expression of ideas, an active/proactive communicator. Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Medical Strategy. Regulatory Compliance. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally: