1738 Pharmacovigilance Jobs - Page 26

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical 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.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Qualification BSc,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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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 Ability to meet deadlinesAbility to work well in a teamAdaptable and flexible 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: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing prioritiesFlexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines 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 Any Graduation

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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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 Agility for quick learningAbility to work well in a teamAdaptable and flexible 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: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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 teamAbility to perform under pressureCommitment to qualityDetail orientation 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 BCom,MCom,Master of Business Administration

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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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 Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleCommitment 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

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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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

Primary Responsibilities: Maintain knowledge of coding and billing requirements and regulatory changes KPIs include but not limited to Productivity, quality, TAT, Attendance and Attrition Quick turnaround using logical understanding of data Manages overall personnel, performance, and discipline of the assigned project(s) Provide expertise and leadership in assigned functional area Manage relationship with internal stakeholders and functions Manage all client interaction and client communication. Should front end the relationship with the client Review and analysis of periodic reports and metrics Evaluation of operational practices and procedures Provide support to quality initiatives targeted towards process improvements Actively involved in the internal audit support, ensuring all compliance parameters are met Establish and maintain a working environment conducive to positive morale, individual style, quality, creativity, and teamwork Provide direction to staff; ensure resolution of problems; sets priorities Actively provides inputs and assistance to the senior management in the planning, implementation, and evaluation / modifications to existing operations, systems, and procedures, specifically relating to his/her assigned project(s) Managing attrition and building retention strategies Preparation of annual business plans including operating budgets Negotiating solutions, resolving conflicts and anticipating/handling critical situations Providing regular performance feedback and giving frequent formal and informal coaching sessions Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualifications: Education Background: Graduate or Postgraduate in: Life Sciences, Allied Medicine (BHMS, BAMS, BPT, Dental Grads, Pharmacist, Nursing) or others Certification: Certified coder AAPC / AHIMA CCS/CPC/CPC-H/CCS-P 10+ years of coding experience with about 3+ years of experience as a Team Lead Thorough knowledge of medical terminology, human anatomy/ physiology, pathophysiology Knowledge of organizational structure, workflow, and operating procedures Proficient in healthcare reimbursement methodologies\ Proven good analytical and communication skills Proven solid interpersonal and communication skills Proven solid acumen towards employee engagements & driving customer satisfaction Proven ability to work closely with SME, Auditor and Trainer and identify training needs for outliers Proven ability to manage and enable teams to reach their goals Proven ability to effectively provide 1 on 1 coaching Proven ability to monitor absences and overall day to day operations Proven ability to identify areas of weakness and provide educational teaching to improve those areas of weakness

Our Client: Client operates in the health tech or remote health monitoring industry. It specializes in providing contactless health monitoring solutions using AI-powered sensors to track vital signs like heart rate, respiration, and sleep patterns. Their technology is often used in hospitals and home care settings for continuous, real-time health monitoring and early detection of medical conditions. Job Title: Manager- KOL Engagement Education: Any Graduate Experience: 4 - 7 Years of relevant exp Location: Chennai / Coimbatore About the Role: The Manager - Key Opinion Leader Management will be responsible for engaging with key doctors and healthcare professionals in partner hospitals. This role focuses on building meaningful relationships with these stakeholders, effectively communicating our research, evidence, and product features, and helping them understand the impact of the solutions in enhancing patient safety. Responsibilities: Stakeholder Engagement: Build and maintain strong relationships with key opinion leaders (KOLs) such as senior doctors, medical directors, and department heads in partner hospitals. Conduct one-on-one interactions to understand their needs, address concerns, and provide tailored solutions. Research Communication: Present the companys research, clinical evidence, and product efficacy in a compelling and professional manner to healthcare professionals. Product Advocacy: Demonstrate the features and benefits of the company's products and solutions, emphasizing their role in enhancing patient safety and operational efficiency. Gather feedback from KOLs on product performance and relay insights to internal teams for continuous improvement. Relationship Management: Act as the primary point of contact between company and the medical community, ensuring consistent communication and fostering trust. Support KOLs in adopting the company's solutions and advocate for their integration into hospital workflows. Strategic Collaboration: Collaborate with the sales, marketing, and R&D teams to align KOL engagement strategies with organizational goals. Assist in co-creating marketing materials and evidence-based content with input from KOLs. Monitoring & Reporting: Maintain detailed records of interactions with KOLs and track the progress of ongoing engagements. Prepare and present regular reports on KOL activities, feedback, and their impact on business outcomes. Requirements: Bachelors or Master’s degree in Medical, Life Sciences, Healthcare, Pharma or a related field. 5+ years of experience in KOL management, healthcare engagement, or a similar role. Prior experience in working with doctors and hospitals on research and medical trials findings, with a deep understanding of the healthcare ecosystem and hospital operations. Confident and persuasive personality with excellent interpersonal and presentation skills. Willingness to travel extensively, up to or exceeding 15 days per month .

🚀 Join the AI Worker Revolution as Co‑Founder! (Gujarati First preferences Doctors , Pharma company owner, Chemical company , Hospital owner) 🚀 Are you ready to ride the next wave of AI-powered enterprise productivity? At Phytoz‑AI (🌐 phytoz‑ai.com), we’re building the world’s most advanced AI Employee platform for Healthcare, Pharma, Biotech & Chemical industries—and we want you on our founding team. Why Phytoz‑AI? Outperforming the Competition We’ve benchmarked ema.co and 11x.ai —and our MVPs already leave them in the dust. AI MLR Pre‑Check ✅ AI Pharmacovigilance (PV) ✅ AI Radiology Report Generator ✅ Massive Global Opportunity The healthcare AI market is projected to hit $1000 billion by 2027. Be part of the startup that defines the category. Bootstrapped & Moving Fast No decks. No endless slide‑decks. You’ll dive straight into product, partnerships, and revenue. Who We’re Looking For Gujarati entrepreneurs with startup grit Expertise in AI/ML, healthcare operations, regulatory affairs, or enterprise sales Hunger to scale globally—no borders, only big wins Ready to commit, communicate, and crush milestones Your Mission Co‑build and refine our AI Worker suite Close strategic partnerships with pharma and biotech leaders Drive go‑to‑market and viral growth strategies Share equity, vision, and the thrill of a billion‑dollar exit Ready to Ride the Wave? 👉 Study ema.co & 11x.ai to see why Phytoz‑AI is leaps ahead. 👉 Text me directly —no time wasted: +91 97263 59459 (Founder, Phytoz‑AI) 👉 Let’s build tomorrow’s AI workforce—today! Act fast. Seats on the founding team are extremely limited. Grow with us. Change healthcare. Own the future. — Mahendra Ribadiya Founder, Phytoz‑AI +91 97263 59459 | 🌐 phytoz‑ai.com

We are hiring a dedicated and licensed Pharmacist to ensure safe and accurate dispensing of medications. The role involves managing inventory, interpreting prescriptions, maintaining patient records, and guiding patients about medicine usage. The ideal candidate should have sound knowledge of pharmaceuticals, excellent communication skills, and the ability to work responsibly in a healthcare environment. Job Requirements Minimum 1 to 2 years of experience in Ayurvedic medicine dispensing . Pharma or B. Pharma from a recognized institute Counsel patients on dosage, usage, and side effects ollaborate with doctors and nursing staff for patient care Maintain inventory and storage of medicines Job Benefits rofessional and respectful work environment pportunity to grow in a reputed healthcare organization Supportive team and on-job learning exposure. Required Skills Customer Service Problem Solving Good Communication

Career Category Regulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE The Digital Governance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by managing the tracking and documentation of Amgen s global digital sites and projects for compliance purposes. The Sr. Associate Digital Governance will support the Digital Governance Business Process Owner (DSR BPO) in maintaining the accuracy of Amgen s global digital site database. They are responsible for ensuring database records are kept up to date, responding to inquiries for database reports, following up on pending actions, and assisting users with process-related questions. This role will be on a flex shift to allow for live training and collaboration. Roles & Responsibilities: Support tracking and documentation of Amgen s global digital sites and projects for compliance purposes Promote compliance for Amgen s digital and social media asset inventory Provide guidance to inquiries regarding Amgen s global digital database Assign training as needed to Amgen employees who manage or support digital assets Update formal process documents (SOPs, guidance/training documents) as needed Quality check digital assets against database information to ensure accuracy Follow up on overdue database task assignments Work with Domain Law to register Amgen URLs Support Digital Governance management in identifying areas of risk and concern Execute and document effectiveness checks Support corrective actions and regulatory inspections Maintain weekly and quarterly database reports Test digital site contact information to ensure compliance Provide Project Management support to key initiatives Maintain project management standards and methodology Provide change management support to key initiatives Required Knowledge and Skills: Deep knowledge of Veeva PromoMats database management processes Excellent written/oral communication skills and attention to detail Strong problem-solving skills and the ability to navigate complex situations Adaptability to assist in meeting urgent goals in a complex environment Familiarity with pharmaceutical regulatory compliance requirements (US and global) Experience with social media and website management Knowledge of Excel Ability to work collaboratively in a team environment Project Management Change Management Preferred Knowledge and Skills: Understanding of pharmaceutical regulatory compliance requirements in a global database environment Awareness of social media requirements and processes Basic Education and Experience: Master s degree OR Bachelor s degree and 3 years of related experience OR Associate s degree and 5 years of related experience Preferred Education and Experience: Master s or bachelor s degree Experience working in a Global Regulatory Affairs or Pharmacovigilance organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications. EQUAL OPPORTUNITY STATEMENT .

Career Category Safety Job Description The PV Scientist Manager is responsible for the following: Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports Works with affiliates and other internal Amgen partners regarding deliverables Review of AE/SAEs from clinical trials as needed Contributes under the direction of the Global PV Sr. Scientist or Lead to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO Prepare safety assessment reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Participates in Safety Governance per Amgen processes Prepare presentation of the Global Safety Team s recommendations on safety issues to the cross-functional decision-making body Assist GSOs and other Senior Scientists in the development of risk management strategy and activities Provides contents for risk management plans Update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her 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 The PV Scientist contributes to GPS in the following ways: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Participates on teams for the implementation of new processes and methods within the Therapeutic Area Basic Qualifications and Experience: Master s or Bachelors degree with minimum 9+ years of experience in relevant fields. .

We are hiring Trainers/ Faculty/ Lecturer for our Pune branch to teach topics clinical research, medical coding, drug discovery Pharmacovigilance. Contact 9856963895 Eligibility : Msc(microbiology), Bpharm, Mpharm, Pharm D

India - Hyderabad JOB ID: R-218929 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jul. 01, 2025 CATEGORY: Safety The PV Scientist Manager is responsible for the following: Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports Works with affiliates and other internal Amgen partners regarding deliverables Review of AE/SAEs from clinical trials as needed Contributes under the direction of the Global PV Sr. Scientist or Lead to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO Prepare safety assessment reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Participates in Safety Governance per Amgen processes Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body Assist GSOs and other Senior Scientists in the development of risk management strategy and activities Provides contents for risk management plans Update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her 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 The PV Scientist contributes to GPS in the following ways: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Participates on teams for the implementation of new processes and methods within the Therapeutic Area Basic Qualifications and Experience: Master’s or Bachelor's degree with minimum 9+ years of experience in relevant fields.

India - Hyderabad JOB ID: R-219154 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jul. 01, 2025 CATEGORY: Regulatory ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE The Digital Governance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by managing the tracking and documentation of Amgen’s global digital sites and projects for compliance purposes. The Sr. Associate – Digital Governance will support the Digital Governance Business Process Owner (DSR BPO) in maintaining the accuracy of Amgen’s global digital site database. They are responsible for ensuring database records are kept up to date, responding to inquiries for database reports, following up on pending actions, and assisting users with process-related questions. This role will be on a flex shift to allow for live training and collaboration. Roles & Responsibilities: Support tracking and documentation of Amgen’s global digital sites and projects for compliance purposes Promote compliance for Amgen’s digital and social media asset inventory Provide guidance to inquiries regarding Amgen’s global digital database Assign training as needed to Amgen employees who manage or support digital assets Update formal process documents (SOPs, guidance/training documents) as needed Quality check digital assets against database information to ensure accuracy Follow up on overdue database task assignments Work with Domain Law to register Amgen URLs Support Digital Governance management in identifying areas of risk and concern Execute and document effectiveness checks Support corrective actions and regulatory inspections Maintain weekly and quarterly database reports Test digital site contact information to ensure compliance Provide Project Management support to key initiatives Maintain project management standards and methodology Provide change management support to key initiatives Required Knowledge and Skills: Deep knowledge of Veeva PromoMats database management processes Excellent written/oral communication skills and attention to detail Strong problem-solving skills and the ability to navigate complex situations Adaptability to assist in meeting urgent goals in a complex environment Familiarity with pharmaceutical regulatory compliance requirements (US and global) Experience with social media and website management Knowledge of Excel Ability to work collaboratively in a team environment Project Management Change Management Preferred Knowledge and Skills: Understanding of pharmaceutical regulatory compliance requirements in a global database environment Awareness of social media requirements and processes Basic Education and Experience: Master’s degree OR Bachelor’s degree and 3 years of related experience OR Associate’s degree and 5 years of related experience Preferred Education and Experience: Master’s or bachelor’s degree Experience working in a Global Regulatory Affairs or Pharmacovigilance organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen’s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications. 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.

Job Summary We are looking for the Primary scientific face of the organization to ‘Thought Leaders’ & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities • You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan • You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects • You will be a therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients’ treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart • You will be responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals • You will have to represent the organization in various internal & external scientific platforms • You will have to gather deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams. • You will need to proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan • You will be receiving and processing scientific information requests received from physicians • You will have to ensure that all activities in the region are conducted in alignment to organisation’s COBE (Code of Business Ethics) Policy and compliance guidelines. • You will need to collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in reputed journals. • You will be responsible for devising an optimal training plan to ensure the flow of the latest medical developments to the sales and marketing teams. • You will jointly be responsible with the therapy area lead to support optimal patient outcomes through communication of data, information, knowledge, and insights in support of healthcare professional needs and organizational goals. • Representing the organization in various internal and external scientific platforms will be among your responsibilities. • You will be responsible for developing the Medical Affairs strategic plan for identified therapeutic areas and products. • Your ability to convert insights on disease trends and treatment patterns from key thought leaders into viable and formidable strategic plans to shape the therapeutic areas of interest will be vital. • You will be responsible for identifying knowledge gaps, practice gaps, and data gaps and developing strategic medical action plans, including but not limited to medical education, product education, evidence generation, and special projects, will fall under your responsibility. • Collaborating with thought leaders to conduct therapy-specific reviews, meta-analysis, case studies, case series, patient-reported outcomes, and publishing them in reputable journals will be part of your role. • Handling complex questions from healthcare professionals related to GGI products or disease areas to satisfaction will be a key responsibility. • You will be responsible for ensuring that all activities in the therapeutic area are conducted in alignment with Dr. Reddy's COBE (Code of Business Ethics) Policy and compliance guidelines will be essential. • You will be responsible for ensuring that all promotional, physician, and patient education materials are approved within stipulated timelines and in alignment with Dr. Reddy's Promotional Material approval policy. • As a product pipeline champion, you will have the ability to identify unmet needs through active stakeholder interactions and actively contribute to the new product ideation and development of differentiated products. Qualification Educational Qualification- MBBS with full time post-graduate qualification of at least 2-years’ duration in any discipline of medicine/ M.B.B.S with M.B.A. from a reputed institute Minimum work experience- Fresh postgraduate or up to 2 years of experience in Field based Medical Affairs. Skills & attributes – Technical Skills • Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data • Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship • Experience with complex business environments preferred • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Behavioural Skills • Integrity driven decision making skills • Collaboration and teaming with ability to work in a matrix environment • Strategic thinking & sound analytical skills • Big picture orientation with attention to detail • Sense of urgency & desire to excel • Intellectual curiosity • Self-awareness and adaptability • Result oriented and performance driven • Excellent interpersonal & communication skills to effectively interact with a broad range of audience. Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Location Bengaluru, Karnataka, India Job ID R-205150 Date posted 02/07/2025 Job Title - Director Principal Patient Safety Scientist Career Level - F Location: Bengaluru Job Description / Capsule Accountable for the performance and results across a team within the span of Patient Safety deliverables for Marketed Products. Sets team member objectives/plans to ensure the delivery of business objectives. Review and approval of key drug safety documents and act as the drug safety expert within own team. Typical Accountabilities Manages a team of Patient Safety staff locally. Develops, or uses expertise to support the development of, strategies and objectives for Patient Safety in area of responsibility, and ensures these are aligned to broader AstraZeneca goals and objectives Maintains a high degree of understanding and awareness of internal and external trends influencing the PS domain, and shares this with team members as appropriate Builds networks with other teams and external stakeholders to learn about new developments, leverage opportunities and share best practices May manage or support projects to improve processes within Patient Safety or develop and introduce new technologies and approaches at the national, regional or global level Ensures that own work and work of the team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards Accountability for Oversight of SSaMT input to projects (technical) as well as line and resource management Expected to Deputise for PV science Director as requested Line management and team leadership accountabilities Recruitment, development, and retention of talent. Ensure full implementation of all Patient Safety and GMD strategic change programs in own team. Sharing best practice across teams in PS Partner with QPPV and QPPV office and PS Risk Management Group A key member of the local leadership team; partner with Senior PV Medical Directors Lead or be involved in local/global change/improvement project Typical People Management Responsibility (direct/indirect reports) The approximate number of people managed in total (all levels) - 10 – 12 Manager of a team Education, Qualifications, Skills, and Experience Essential Medical degree Experience in Patient Safety in the pharmaceutical industry Excellent communication skills Project management experience Knowledge of relevant legislation and developments in the Pharmaceutical industry Medical or other life science degree or appropriately qualification as Health Care Professional PV Professional (Scientist), Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man Desirable Ph.D. in a scientific discipline Date Posted 03-Jul-2025 Closing Date 18-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Job Description / Capsule Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of AstraZeneca medicines. Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco- economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Scientific Expertise Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca’s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical. Customer Insight: Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Essential Education, Qualifications, Skills and Experience Scientific and or a master’s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Date Posted 01-Jul-2025 Closing Date 30-Aug-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Job Description / Capsule Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of AstraZeneca medicines. Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco- economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Scientific Expertise Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca’s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical. Customer Insight: Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Essential Education, Qualifications, Skills and Experience Scientific and or a master’s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Date Posted 01-Jul-2025 Closing Date 30-Aug-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. 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 to worldwide regulations. The Global PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS. Applicable tasks may vary by product(s) assigned. The Global PV Sr. Scientist is responsible for the following: Directs the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products Supports and provides oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review of AEs/SAEs from clinical trials as needed Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Participate in study team meetings as requested or needed Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results Documents work as required in the safety information management system Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans Develop or update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed. Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO in developing a strategy for safety-related regulatory activities Provide safety contents for filings 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 Knowledge and Skills Processes and regulations for pharmacovigilance and risk management Drug development and lifecycle management Safety data capture in clinical development and post-market settings Safety database structure and conventions MedDRA and other dictionaries used in pharmacovigilance Methods of qualitative and quantitative safety data analysis Product and disease state knowledge Risk management and risk minimization Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labelling Advanced understanding of interfaces across various pharmacovigilance and risk management processes Internal organizational and governance structure Pharmacovigilance skills-intermediate knowledge of the following: Signal detection, evaluation and management Aggregate data analysis, interpretation and synthesis Good clinical and scientific judgment Application of medical concepts and terminology Document writing and source document review Writing Risk Management Plans Ability to convey complex, scientific data in an understandable way Ability to analyze and interpret complex safety data Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance Biomedical Literature-intermediate skills: Literature Surveillance: source document review knowledge and skills Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills Other Skills-intermediate Skills In The Following Organization, prioritization, planning skills Collaboration with cross-functional team settings Meeting management and time management skill Process and project management Critical scientific assessment and problem solving Strong Written and verbal communications skills, including medical/scientific writing Computer skills (e.g., MS Office Suite and safety systems) Strategic thinking Influencing and negotiation in a cross-functional, matrix environment Presentation skills for conveying complex technical contents to non-expert audiences KNOWLEDGE Broad PV knowledge with expertise within defined subject area Applies knowledge and broad understanding of multiple disciplines Understands impact of emerging scientific/technical trends and their implications for Amgen PROBLEM SOLVING Analyzes and forecasts scientific/technical trends Develops solutions to problems through in-depth analysis, coordination and negotiation with key decision makers Performs complex work-flow analysis on processes impacting multiple areas across the organization Adapts and integrates own experience with Amgen-wide strategy Develops innovative solutions to problems without precedent Proposes new processes to achieve strategic business objectives Works in partnership with GPS team to develop business plans that support the direction of the business AUTONOMY Guided by business plans and strategy Executes strategy, goals and changes within area of responsibility Contributes to strategic decisions affecting the discipline Guides ideas through development into a final product CONTRIBUTION Contributes to business results through quality of results, advice and decisions related to the operations of the discipline Designs and develops global processes, systems and/or applications Contributes to organizational through leadership May accomplish business results through leveraging a team of professionals and/or managers Develops mutually beneficial strategic alliances with internal and external contacts Education & Experience (Basic) Doctorate/Master’s degree/Bachelor’s degree and 12 to 17 years of directly related experience Education & Experience (Preferred) BS or BA in Life Science with a MS and 12 years of related experience And 2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources Clinical/medical research experience 6 years of experience in a biotech/pharmaceutical/CRO setting Previous management and/or mentoring experience

Knowledge Park Pvt Ltd is looking for Laboratory Technician (Pharmacy) to join our dynamic team and embark on a rewarding career journey. The Laboratory Technician performs laboratory tests and experiments, maintains laboratory equipment and supplies, and assists in the development of new laboratory techniques and procedures. 1. Collect and prepare laboratory samples for analysis. 2. Perform laboratory tests and experiments according to established protocols and procedures. 3. Analyze test results and prepare reports for interpretation by laboratory professionals. 4. Maintain laboratory equipment and supplies, including cleaning and sterilizing equipment and ordering supplies when needed.

PV Supervisor We are currently seeking a Supervisor, Pharmacovigilance to join our diverse and dynamic team. As a Supervisor, Pharmacovigilance at ICON, you will play a pivotal role in overseeing the safety monitoring and reporting of adverse events related to clinical trials and marketed products. You will contribute to ensuring patient safety and regulatory compliance through effective management of pharmacovigilance activities, coordination with cross-functional teams, and maintaining the highest standards of safety reporting. Roles & Responsibilities: The Supervisor Pharmacovigilance supervises a subordinated group and oversees the related tasks. The Supervisor Pharmacovigilance supports creation and updates of SOPs, participates in departmental process and system improvement initiatives. Reviews project tasks performed by the group and provides leadership in the delivery of related services to clients. Is actively working on the tasks the subordinated job role performs as per the respective job description. Supervises case workflow. Assists or provides oversight with organization and planning of meetings, including preparation and distribution of presentations, agendas, and meeting minutes, as requested. Ensure adequate maintenance of SAE Hot Line, and other departmental phone lines, including documenting contacts and submitting to appropriate personnel. Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff. Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes. Identifies and implements process improvements through review of SOPs, processes and recommends improvement plans to senior management. Participates in task forces to implement process improvement initiatives. Builds teamwork and improves process and productivity by working within and across functional areas. Creates an environment that encourages learning, self-improvement and career development for staff. Supports the development and implementation of training for the subordinated group or other personnel within the assigned service area. Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed. Develops company employees to ensure high quality work performance and retention of high-quality employees. Ensures staff development and performance feedback are provided through activities such as mentorship and career development. Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities. Involved in the recruiting processes for new employees within the assigned service area. May serve as Local/Qualified Person for Pharmacovigilance (including deputy level). Supervision Given Directly supervises support-level staff and/or entry level professionals. Work is done independently and reviewed at critical points. What You Will Be Doing: Supervising the day-to-day pharmacovigilance operations, ensuring timely and accurate reporting of adverse events. Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to optimize pharmacovigilance processes. Ensuring compliance with global regulatory requirements and internal standard operating procedures for safety reporting. Managing safety data collection, analysis, and submission to regulatory authorities. Providing leadership and training to the pharmacovigilance team, ensuring adherence to best practices in safety monitoring. Your Profile: Bachelor s degree in life sciences, pharmacy, or a related field. Experience in pharmacovigilance or drug safety, with a focus on clinical trials or post-marketing surveillance. Strong knowledge of global pharmacovigilance regulations and guidelines. Excellent communication, leadership, and organizational skills, with the ability to manage a team effectively. Detail-oriented with the ability to manage multiple tasks and ensure accuracy in safety reporting. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply