Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of a collaborative team developing and implementing the next generation of safety platforms and supporting technologies. In this role, you will be responsible for designing, developing and deploying complex software applications, and mentoring junior developers. You will work closely with the business to develop high-quality, scalable and maintainable solutions. Roles & Responsibilities: Design, develop and deploy applications to support pharmacovigilance systems. Develop and maintain solutions to enhance E2E data reconciliation, ensuring consistency and accuracy across systems related to adverse events/product complaints Develop innovative solutions using generative AI technologies including large language models (LLMs) like Open AI GPT for enhanced decision making and drive efficiency Using strong rapid prototyping skills, quickly translate concepts into working code. Conduct code reviews to ensure code quality and consistency to standards. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges effectively. Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-systems. Find opportunities for automation and process improvements within drug-safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems Change Control and GxP validation process. Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines. Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions. Responsible for supporting technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues. Basic Qualifications and Experience: Master’s degree with 4 to 6 years of experience in Computer Science, software development or related field Bachelor’s degree with 6 to 8 years of experience in Computer Science, software development or related field Diploma with 10 to 12 years of experience in Computer Science, software development or related field Must-Have Skills: Experienced in database programming languages, data modelling concepts, using SQL and Databricks. Experienced with reporting tools such as Tableau and Power BI. Experienced in one or more general programming languages, including but not limited toJava or Python. Excellent problem-solving skills and a commitment to resolving challenges. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Extensive experience with SDLC. Collaborative spirit and effective communication to seamlessly work in a multi-functional team. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experience with Application Programming Interface (API integrations) such as MuleSoft and Extract Transform Load (ETL tools) as Informatica platform, and Databricks. Outstanding ability to explain technical concepts to non-technical clients. Knowledge with ITIL process Support technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems (IS) Change Control and GxP validation process Demonstrate the ability to make informed technology choices after due diligence and impact assessment Good-to-Have Skills: 3+ years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database. Experienced in managing GxP systems and implementing GxP projects Experienced with Cloud Technology such as AWS, Azure Experience with DevOps Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Professional Certifications: Certified SAFe® Agile Software Engineer SAFe for Teams certification (preferred) Soft Skills: Strong verbal and written communication skills Excellent analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to deal with ambiguity and prioritize Team-oriented, with a focus on achieving team goals Ability to influence and drive to an intended outcome and hold peers accountable, and work effectively with global, virtual teams Ability to hold peers accountable to commitments Shift Information This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation .

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you are part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Specialist Software Engineer – E2E Reconciliation What you will do As a Specialist Software Engineer, you will join a collaborative team developing and supporting the next generation of safety platforms and supporting technologies. In this role, you will be responsible for designing, developing and deploying complex software applications, and mentoring junior developers. You will work closely with the business to develop high-quality, scalable and maintainable solutions. Design, develop and deploy applications to support pharmacovigilance systems. Develop and maintain solutions to enhance E2E data reconciliation, ensuring consistency and accuracy across systems related to adverse events/product complaints Develop innovative solutions using generative AI technologies including large language models (LLMs) like Open AI GPT. Using strong rapid prototyping skills, quickly translate concepts into working code. Contribute to both front-end and back-end development using cloud technologies. Conduct code reviews to ensure code quality and consistency to standards. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges effectively. Stay updated on industry trends, emerging trends and standard processes for pharmacovigilance systems. Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-systems. Find opportunities for automation and process improvements within drug-safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines. Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions. Responsible for supporting technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues What we expect of you Master’s degree with 4 to 6 years of experience in Computer Science, software development or related field (OR) Bachelor’s degree with 6 to 8 years of experience in Computer Science, software development or related field (OR) Diploma with 10 to 12 years of experience in Computer Science, software development or related field Must Have Skills: Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Experienced with reporting tools such as Tableau, Cognos, Business Objects. Experienced in one or more general programming languages, including but not limited toJava or Python. Excellent problem-solving skills and a commitment to resolving challenges. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Extensive experience with SDLC. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experience with Application Programming Interface (API integrations) such as MuleSoft and Extract Transform Load (ETL tools) as Informatica platform, and Databricks. Outstanding ability to explain technical concepts to non-technical clients Good to Have Skills: 3+ years of experience COTS Pharmacovigilance Platforms (for example Argus, ARISg) is a plus or other safety database. Experienced in managing GxP systems and implementing GxP project Certification: Certified SAFe® Agile Software Engineer Soft Skills: Strong verbal and written communication skills Excellent analytical and problem-solving skills Ability to work effectively with global, virtual teams Ability to deal with ambiguity and prioritize Team-oriented, with a focus on achieving team goals Ability to influence and drive to an intended outcome Ability to hold peers accountable to commitments Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

As a Therapy Business Manager you will be responsible for developing and implementing all sales strategies in the assigned market. Further you will drive primary and secondary sales, ensure brand presence in the assigned market and manage the distributor network to achieve desired sales/business objectives. Roles and Responsibilities in detail Business Generation & Development Achieve monthly, quarterly, half yearly and yearly sales target by promoting company’s product ethically to customers as per the business plan Having science-based discussion with doctors and chemists for promotion of product in clinic and at chemist place Organizing Camps (CME) as per the division strategy and customer needs To plan and conduct merchandising and sampling activity as per Division strategy. Facilitate the process of successful new product / products launch in the territory by undertaking correct identification and targeting customers for the new product, meet them at pre-determined intervals, effective in clinic / trade promotion and share feedback with the company Execute the customer management plan to ensure that all the customers are covered as per the plan and meet minimum KPIs as follows: a. 100% coverage of Doctors. b. Customer Call average as per the customer management plan of the division / therapy. c. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy / division. Prescription audit for Abbott brands and other competitors’ brands To create and update customer list having specified number of doctors / chemist (Trade) as per the therapy / product requirement and maintain the same in physical / electronic format. Identifying potential town and appointing distributor and customers (trade) in line with business philosophy Brand Management Ensuring the visibility of Abbott brands on retailers’ outlet as a part of brand promotion strategy To carry out activities across trade and clinics for brand visibility To plan and attend Retail meets, Market Blitz etc. for sales growth Generate POBs for Abbott brands as per the business plan Recommend appointment of a party as a distributor after evaluating its commercial standing, credit worthiness and personal assets. Ensure that stock and sales statements have been sent by the distributors on due dates Ensure that the claims of the distributors are settled by company within specified time limits Responsibilities You are manager of the company in your territory and will be authorized to build company’s reputation in your territory. You will be responsible for practicing and leading other junior team members of the company by setting personal example of excellence in: 1. Lead and execute strict adherence to Abbott Code of Business conduct 2. Set examples on implementation of the code of business conduct, FCPA , Pharmacovigilance to ensure compliance 3. Conformation to all financial and administration systems, compliance to statutory and regulatory norms of the company and laws of the land 4. Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring and Enduring 5. Ensure high level of customer service and manage any difficult customer situations. 6. Ensure compliance with internal and external guidelines and ensure minimal comments in audits and other inspections 7. Ensure transactions and orders are processed with a high level of accuracy and commitment in order to satisfy customer needs 8. Manage attrition of customer and resource bases 9. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest 10. To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programmes and any other programmes undertaken by the company to equip you or activities for performance of your job or promote the sales of product of the company or to improve company image. 11. Ensure adherence to EHS policies, procedures, rules and regulations. Attend all required EHS trainings as applicable. Wear safety gears (e.g. Helmet) while riding on two-wheeler. Report any EHS incidents and/or near misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision. Show more Show less

Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402 Show more Show less

JOB DESCRIPTION: As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Division's success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. #LI-DNI The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Sales Force DIVISION: EPD Established Pharma LOCATION: India Chennai : 147 Greams Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 100 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402 Show more Show less

Hi Job Seekers, This is very urgent job opportunity. Please go through this job description and send me your updated resume. ( Full Time Payroll Hucon Innovations ) Location : Pune The Salesforce requirement has been reopened and is of high priority. Please share suitable profiles as soon as possible to proceed further. Position: Mid-Level Salesforce Developer Experience : 4 - 7 years Resource Type: C2C Job Location: Hybrid [Pune, if client required candidate need to visit office] Start Date: Immediate Job Description: We are seeking one mid-level Salesforce Developers for a 6-month project to support Client Product, a leading global provider of advanced analytics, technology solutions, and contract research services. The ideal candidates will have experience in the Pharmacovigilance (PV) and Safety area of the pharmaceutical industry. Key Responsibilities: Develop and customize Salesforce applications to meet project requirements. Ensure seamless integration with existing systems and workflows. Provide technical support and troubleshooting as needed. Requirements: Proven experience as a Salesforce Developer. Familiarity with Pharmacovigilance and Safety (PV/Safety) in the pharmaceutical industry. Strong understanding of Salesforce platform and its capabilities. Excellent communication and teamwork skills. Preferred Qualifications: Experience Pharmacovigilance (PV) and Safety area of the pharmaceutical industry. Please send me your updated resume at

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Assoc Manager Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 10 to 14 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Operation leadOperation lead Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Adaptable and flexibleAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Prepare and review PSURs as per the Clients Standard Operating Procedures and Work Instructions. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Prepare and review PSURs as per the Clients Standard Operating Procedures and Work Instructions.Send the kick-off meeting (KOM) invite to all the contributors along with agenda, PSUR preparation guide, Previous PSUR, Core Data Sheets (CDSs) or reference safety information, previous PSUR assessment report from HA (if any) and dial-in details.Liaise with CLIENT Drug Regulatory Affairs team and request brand names generic names, country of submission, registration procedure, HA PSUR assessment report (if any), and CDS for reference.Liaise with relevant stakeholders for the inputs required for the PSUR.Notify the processing team to process relevant cases as per the PSUR scheduleCoordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation.Schedule meetings with CLIENT safety physicians to resolve report related queries. Perform activities as lead author and prepare submission ready draft report.Perform peer review of draft reports and provide feedback with the duly filled defect tracker.Capture quality data for metrics reporting.Completeness and accuracy of source documentation provided by CLIENT for PSUR/AR to be ensured.Facilitate Client stakeholders review including QC & QPPV reviewShall address all the comments received from all the CLIENT stakeholders including QC reviewerOn-time escalation of any delayed inputsArchival of all the PSUR related information in dedicated folders on Client Shared Drives Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug safety associateDrug safety associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety senior associateDrug Safety senior associate Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 4 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Ability to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 7 to 11 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Looking for a MBBS graduateLooking for a MBBS graduate Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to perform under pressureProblem-solving skillsDetail orientationResults orientationStrong analytical skillsLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Senior drug safety associateSenior drug safety associate Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs New Associate Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification MSc,Bachelor of Pharmacy,Master of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory New Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Agility for quick learningAbility to work well in a teamAdaptable and flexibleAbility to perform under pressureCommitment to quality Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BCom,MCom,Master of Business Administration

Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Key Stakeholders: Internal Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team Key Stakeholders: External Country Distributors, Health Authority (HA), CMOs and external partners Reporting Structure Reports to: Manager - Labelling ESSENTIAL QUALIFICATION: Bachelor degree or Master s degree in Pharmaceutical sciences or equivalent Experience 4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred) Roles and Responsibilities: Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and query solving. Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates Contribute to the development and/or review of all labeling aspects included in Promotional Material. Development and maintenance of a central repository for all labeling components Competencies Must have solid interpersonal and organization skills for interfacing with others. Knowledge of Health Authority labeling regulations and requirements. Self-directed, motivated, organized, flexible and accountable. Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment. Project management skills is a plus

Main responsibilities: Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. People: Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical regulatory content as per requirement. Interact effectively with stakeholders in medical and pharmacovigilance departments. Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Process: Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. Work with selected vendors within the region to deliver the required deliverables as per the defined process. Design an overall plan of action basis end-customers feedback & improve course content and delivery. Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. Proactively liaise with the Clinical/ Medical/ Pharmacovigilance/ Biostats /Regulatory/ Legal/Regulatory /Corporate Affairs departments to prepare relevant & customized deliverables. About you Experience : >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications ) Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Languages : Excellent knowledge of the English language (to read, write, and speak)

Main responsibilities: Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. People: Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical regulatory content as per requirement. Interact effectively with stakeholders in medical and pharmacovigilance departments. Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Process: Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. Work with selected vendors within the region to deliver the required deliverables as per the defined process. Design an overall plan of action basis end-customers feedback & improve course content and delivery. Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. Proactively liaise with the Clinical/ Medical/ Pharmacovigilance/ Biostats /Regulatory/ Legal/Regulatory /Corporate Affairs departments to prepare relevant & customized deliverables. About you Experience : >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications ) Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Languages : Excellent knowledge of the English language (to read, write, and speak)