1738 Pharmacovigilance Jobs - Page 11

We are looking for a highly skilled and experienced Risk Management Specialist to join our team at Uniqus Consultech, an IT Services & Consulting company. Roles and Responsibility Develop and implement comprehensive risk management strategies to mitigate potential risks. Conduct thorough risk assessments and analyze data to identify trends and patterns. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Design and maintain effective risk management frameworks and procedures. Provide expert guidance on risk management best practices to stakeholders. Monitor and report on risk management performance metrics. Job Requirements Strong understanding of risk management principles and methodologies. Excellent analytical and problem-solving skills with attention to detail. Effective communication and interpersonal skills to work with diverse stakeholders. Ability to prioritize tasks and manage multiple projects simultaneously. Strong knowledge of industry standards and regulations related to risk management. Experience working with risk management tools and technologies.

We are looking for a skilled professional to join our team as an Operations & Strategy Role in Hevo Data, located in [location to be specified]. The ideal candidate will have 2-5 years of experience and a strong background in operations and strategy. Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Analyze data to identify trends and areas for improvement. Collaborate with cross-functional teams to drive process improvements. Design and implement new processes and procedures to enhance efficiency. Monitor and report on key performance indicators to stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Strong understanding of operations and strategy principles. Excellent analytical and problem-solving skills. Ability to work collaboratively with cross-functional teams. Strong communication and interpersonal skills. Experience with data analysis and interpretation. Ability to adapt to changing priorities and deadlines.

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

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Sr Mgr Regulatory Affairs Date: Jul 18, 2025 Location: Bangalore, India, 560064 Company: Teva Pharmaceuticals Job Id: 62865 Who we are The opportunity Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. Support team members with complex issues as a senior expert (especially in responsibilities 2 6). Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership. How you ll spend your day Department Leadership Organize and coordinate departmental tasks, personnel management, and planning. Manage budget and resource planning. Establish efficient internal and cross-departmental processes. Lead projects related to labeling, including project management. Review and approve SOPs for the department and overall processes. Support division leadership and develop strategy, principles, and guidelines. Team Leadership Organize and coordinate team tasks, personnel management and planning. Plan team activities and align with other teams. Labeling Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update) Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monitoring Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Pharmacovigilance Assess need for updates based on Company Core Safety Information (CCSI). Implement PV-triggered and non-PV-triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc. ) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA. Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Participate in project teams to fix the regulatory strategy and prepare expert statements. Respond to authority deficiency letters in collaboration with other departments. Mock-ups Coordinate creation and approval of packaging mock-ups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Industry Representation Participate in working groups (e. g. , Medicines for Europe) to represent the company as an EU labeling expert. Your experience and qualifications Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph. D. Additional leadership qualification is preferred. Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required. The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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

Mgr RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr RA EU Generics Labeling Jul 18, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update). Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Assess need for updates based on Company Core Safety Information (CCSI). Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Participate in project teams to fix the regulatory strategy and prepare expert statements. Respond to authority deficiency letters in collaboration with other departments. Coordinate creation and approval of packaging mockups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Assist with training new team members Your experience and qualifications Experience: 10+ years of total experience and minimum 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD. Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs. Already Working @TEVA The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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

We are looking for a skilled CSSD Technician to join our team at Raigad Hospital and Research Centre. The ideal candidate will have 1-6 years of experience in the field. Roles and Responsibility Operate and maintain medical equipment in the CSSD department. Prepare and sterilize surgical instruments and supplies. Assist surgeons and anesthesiologists during surgeries. Monitor patient vital signs and respond to emergencies. Maintain accurate records of patient information and surgery details. Collaborate with other healthcare professionals to ensure high-quality patient care. Job Requirements Strong knowledge of medical terminology and procedures. Ability to work effectively in a fast-paced environment. Excellent communication and interpersonal skills. Familiarity with hospital policies and procedures. Ability to maintain confidentiality and handle sensitive information. Strong attention to detail and organizational skills.

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

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

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

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

Roles and Responsibility Develop and maintain strong relationships with patients, families, and healthcare professionals. Provide excellent customer service and ensure patient satisfaction. Manage and coordinate patient appointments, scheduling, and communication. Collaborate with healthcare teams to develop and implement patient care plans. Maintain accurate and up-to-date patient records and reports. Identify and address patient concerns and issues promptly. Job Requirements Minimum 2 years of experience in patient relationship management or a related field. Strong knowledge of biotechnology, pharmaceuticals, or clinical research. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced environment and prioritize tasks. Strong analytical and organizational skills with attention to detail. Experience with electronic health records (EHR) systems is an asset.

Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role: Are you ready to make a difference in the world of patient safety? As a Local Case Intake Advisor, you'll be at the forefront of managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. This pivotal role supports specific local Marketing Companies, ensuring compliance with AstraZeneca and national regulatory requirements. You'll be the primary liaison between these Marketing Companies and GBS-PS, working under the guidance of Case Intake Team Managers. Your mission? Deliver routine activities independently, resolve moderate scope and complexity problems, and uphold company values and compliance standards. Accountabilities: Dive into the world of pharmacovigilance by supporting the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products. Engage with Health Authorities for ICSR-related queries and contribute to the operational implementation of the Quality Management System. You'll manage procedural document management, AE/PV training requirements, quality incident reporting, and audit readiness. Collaborate on PV aspects related to Organised Data Collection Programmes, Digital and Social Media activities, and partnerships with external parties. Provide Patient Safety expertise within the local Marketing company, tackling issue management for key products, risk management, and action plan formulation. Participate in ad-hoc local Marketing Company projects to drive success. Essential Skills/Experience: Degree Qualified – Pharmacy/ Medical/ Science Language - Fluent in French Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Influencing, and Conflict Resolution skills. Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients' lives. We empower our teams to perform at their peak by combining cutting-edge science with leading digital technology platforms. Our commitment to innovation drives us to explore new ways of working, creating partnerships and ecosystems that deliver exponential growth. With a focus on data, analytics, AI, machine learning, and more, we are transforming healthcare and making a meaningful impact every day. Ready to take on this exciting challenge? Apply now and be part of a team that's changing lives!

Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role: Are you ready to make a difference in the world of patient safety? As a Local Case Intake Advisor, you'll be at the forefront of managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. This pivotal role supports specific local Marketing Companies, ensuring compliance with AstraZeneca and national regulatory requirements. You'll be the primary liaison between these Marketing Companies and GBS-PS, working under the guidance of Case Intake Team Managers. Your mission? Deliver routine activities independently, resolve moderate scope and complexity problems, and uphold company values and compliance standards. Accountabilities: Dive into the world of pharmacovigilance by supporting the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products. Engage with Health Authorities for ICSR-related queries and contribute to the operational implementation of the Quality Management System. You'll manage procedural document management, AE/PV training requirements, quality incident reporting, and audit readiness. Collaborate on PV aspects related to Organised Data Collection Programmes, Digital and Social Media activities, and partnerships with external parties. Provide Patient Safety expertise within the local Marketing company, tackling issue management for key products, risk management, and action plan formulation. Participate in ad-hoc local Marketing Company projects to drive success. Essential Skills/Experience: Degree Qualified – Pharmacy/ Medical/ Science Language - Fluent in Arabic Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Influencing, and Conflict Resolution skills. Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients' lives. We empower our teams to perform at their peak by combining cutting-edge science with leading digital technology platforms. Our commitment to innovation drives us to explore new ways of working, creating partnerships and ecosystems that deliver exponential growth. With a focus on data, analytics, AI, machine learning, and more, we are transforming healthcare and making a meaningful impact every day. Ready to take on this exciting challenge? Apply now and be part of a team that's changing lives!

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files). Case completion / documentation. Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA. Performing duplicate search of literature cases against updated information in Medical Literature Monitoring (MLM) service provided by EMA. Act as main contact for client/project management. The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required. . Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files). Case completion / documentation. Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA. Performing duplicate search of literature cases against updated information in Medical Literature Monitoring (MLM) service provided by EMA. Act as main contact for client/project management. The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Analyst Qualifications: Any Graduation/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: Japanese - Elementary 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 world’s 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 world’s 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? Agility for quick learning Ability to work well in a team Commitment to quality JPLT (N3 to N5) 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

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy/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 world’s 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 world’s 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? 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. 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. 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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description Required Qualification and Core Competencies for the role: 8-12 years of experience in regulatory affairs in medical device industry. Strong knowledge of Medical Device Rule 2017 Strong knowledge of Drugs and Cosmetics Act Knowledge in the international regulations of Medical Devices in US and EU Sound knowledge on Medical Device Quality Management System ISO 13485 Excellent proficiency with software tools Key Responsibilities Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer). Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines. Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses. Assist in the preparation of technical presentations/ meetings with regulator Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises. Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines. Maintenance of RA database for the responsible franchises in MDRIM tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals. Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal. Ensure on time archival of regulatory submission documents. Supporting Pharmacovigilance and artwork activities for biological products (if applicable) Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Position - Head - Patient Safety, Roche Pharma India Your Opportunity We are seeking an inspiring and committed leader to drive the future of Patient Safety at Roche Pharma India. As the Head of Patient Safety for India, you will be encouraged to drive an industry leading PV system, and integrate safety solutions and insights into clinical practice, collaborating with local and global teams and external stakeholders to drive efficient patient safety outcomes across the region, including Sri Lanka, Bhutan, and Nepal. This role will act as the Patient Safety Lead/Pharmacovigilance Officer in Charge, ensuring comprehensive oversight of all patient safety and pharmacovigilance responsibilities while directly managing a team of Patient Safety Partners. The successful candidate will be a key strategic partner to the entire region and will help craft & own the broader patient safety community as a member of the CEETRIS, Middle East & Africa (CMA) Leadership Team and report directly to the Head of Patient Safety, CMA. Key Responsibilities: Visionary : Inspire the safety vision internally and externally, championing transparency, consistency, and co-creation across the organization Architect : Empower teams to make impactful decisions, enable cross-functional collaboration, and establish a trust-based system within the network Mentor : Develop and mentor teams, encouraging a growth mindset and patient-centric approach Catalyst : Identify and remove obstacles, prioritize optimally, and collaborate to address pharmacovigilance challenges while implementing innovative safety solutions Primary Accountabilities: Local PV System Implementation and Maintenance: Ensure compliance with local and global pharmacovigilance regulations by maintaining an efficient and effective PV system Lead all aspects of local PV operations, proactively identifying and resolving compliance risks Integration of Global Safety Priorities and Local Business Priorities: Align global safety priorities and local business priorities, with local strategies to maximize patient impact Serve as the central point of contact for all internal and external safety-related matters Engagement with Treating Physicians: Engage with treating physicians to gain real-world safety insights and implement actionable solutions Cross-Functional Collaboration: Drive collaboration across cross-functional teams to enhance patient safety strategies and leverage global best practices Leadership of Patient Safety Team: Foster an agile, self-managing patient safety team with a focus on continuous improvement and skill development Who We Are Pharmacovigilance Expertise: Strong understanding of PV and the local and global PV ecosystem, including decision-making processes Leadership and Critical Thinking: Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach Customer-Centric Approach: Strong understanding of patient journeys, healthcare systems, and integrated healthcare solutions Qualifications: MD, HCP, PhD in Life Sciences, Master’s in Public Health, or Pharmaceutical Medicine (not always required but must meet local regulatory expectations) Experience: Significant affiliate-level PV experience and experience in other medical functions such as Medical Affairs or Clinical Operations is a plus Leadership Mindset: Ability to inspire, catalyze, and mentor teams, with a strong focus on safety awareness and critical thinking Agility: Navigate entrepreneurial change and adapt to a dynamic environment External Focus: Supervise industry trends, risks, and opportunities proactively Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Jul 21 2025 Job Purpose LOC Complaint Handler. Handling of Counterfeit/Suspected Counterfeit incidents. Toll free service coordinator Deviation Coordinator CAPA Coordinator Key Responsibilities LOC COMPLAINT HANDLER Route the customer communication Handle communication received from Tech Mahindra as per SOP for Handling calls received on Toll free number for Pharma and Vaccines Log the complaint in a validated system (as applicable) and assess criticality. Follow-up with customer and request sample unless justified that the sample is not required. Route complaint and any sample to the investigating site based on the defect observed. Assess/review if complaint is associated with HSI/AE and if it is, inform the local Pharmacovigilance (PV) representative within 24hrs. Maintain any Safety data cross-references and forward any follow-up information to the local/Global PV representative. Ensures that any HSI data cross-reference is maintained Reviews the complaint data for any other similar complaints from the role of product complaint handler. Forward complaints which are not related to product quality to concerned stakeholders (e.g.: Complaints on market shortages to distribution department, AE & SAE related to PV/Medical) Perform local trending of complaints and escalate adverse trends to Safety and/or Quality functions. Perform monthly reconciliation of HSI with the PV/safety (Global Service Provider). Escalate actions which may be overdue or at risk of non-compliance to LOC quality council. Carry out an annual review of the process so that it continues to be effective and to identify improvement. To share complaint tracker and reconciliation with global service provider. COUNTERFEIT HANDLER: To log the complaint for received suspected counterfeit product and record the information received. To forward the suspected counterfeit sample and received information/ documents to the manufacturing site for investigation Coordinate with LOC regulatory if any discussion with local regulators is required. Call for LIC/PIRC if the site confirms of confirmed counterfeit Coordinate with Legal Brand Protection (LBP) to report the suspected counterfeit. To escalate to Quality council as appropriate To generate AFPR report in case of confirmed counterfeit. TOLL FREE SERVICE COORDINATOR: To ensure SOP in place and in use. To ensure Toll free third party employee are trained on applicable trainings. Ensure Monthly KPI reporting by third party as per SOP. To provide the updates to quality council. To support third party if they have a confusion or doubt in the communication received. To provide standard response in case of repeat product queries, as applicable. To perform monthly reconciliation of Toll-free communications received as per SOP. DEVIATION CO-ORDINATOR: Ensure deviation are raised for nonconformance from the applicable procedures. Track and monitor all the deviations of LOC function for timely closure. Escalate critical incident / deviations at Quality Council or LOC governance forums. Monitor periodic trend reviews of deviations, including assessment of effectiveness of action taken. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Report deviation KPIs to relevant governance forums and for monthly reporting as required CAPA CO-ORDINATOR: Implement global process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s. Implement a local process to track and review CAPA plans on routine basis. Manage CAPA’s for the entire LOC and ensure that CAPA’s arising out of a non- compliance is logged into VQMS. Demonstrate that LOC effectively identifies where CAPA plans are required and that they are effectively implemented, monitored and closed out. Escalate actions which may be overdue or at risk of non-compliance to LOC Quality Council. Ensure KPIs are introduced that provide assurance that the process is effective and drives improvement. Report CAPA KPIs to relevant governance forums and for monthly reporting as required. OTHER: To perform the QMS gap assessment for the relevant system, where required. Preparation, revision of LSOPs as per requirement. To perform MM, Third party audits, Scoping visit of third party after appropriate qualification Identify and log risk and outline, monitor and implement appropriate mitigation plans. To collate and submit data for KPI management and other governance forum like QC, EMQC, RMCB etc. Complete mandatory trainings by the due date. Perform a job only after completion of training on that topic. Ensure that all internal procedures and systems which are in LOCQ are followed and complied with. Any additional responsibility assigned by the line manager as and when required. Knowledge/ Education / Experience Required Educational Background Minimum Level of Education - Graduate in Science / Pharmacy Area of Specialisation - Broad and through technical and regulatory knowledge of current pharmaceutical processes, QMS activities such as Complaint Management, Change control, deviations and CAPA management. Why is this Level of Education Required? - To support LOC Quality and to carry out all the responsibilities mentioned under the given job role Job-Related Experience Minimum Level of Job-Related Experience required Preferably 3 -10 years experience in Quality Assurance in Pharmaceutical industry. Having adequate knowledge of complaint management system and experience in handling of complaints as per quality assurance function. Why is this Level of Experience Required - To support LOC Quality and to carry out all the responsibilities mentioned under the given job role Other Job-Related Skills/Background Good knowledge of documentation / regulatory requirements and quality management system. Breath knowledge in quality systems principles and practical application. Good knowledge of quality management tools. Demonstrated sound decision-making process, based on the facts and data, and application of Risk management principles. Exposure and competencies with respect to multiple dosage forms. Excellent verbal and communication skills, collabrative team member and team leader. Demonstrated ability to effectively multi-task. Ability to excel in execution Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

We are seeking an experienced clinical research trainer to educate and mentor students/professionals in clinical research methodologies, regulations, and best practices. The trainer will be responsible for conducting interactive training sessions, preparing course materials, and ensuring that participants develop strong industry-relevant skills. Key Responsibilities Deliver training sessions on clinical research, GCP (Good Clinical Practice), regulatory affairs, pharmacovigilance, and related topics. Design, update, and improve training materials, presentations, and assessments. Conduct both classroom and online training sessions as per company requirements. Assess and evaluate trainees' understanding through tests, assignments, and practical exercises. Stay updated with the latest industry trends, guidelines, and regulatory changes. Provide career guidance and mentoring to students/professionals. Collaborate with industry experts to enhance training effectiveness. About Company: PMCTI stands for Pune Medical Coding Training Institute. We are a leading provider of medical coding training in Pune, India, dedicated to empowering individuals with the knowledge and skills necessary to thrive in this dynamic and rewarding healthcare field. Our team is comprised of passionate and experienced professionals who share a deep commitment to education and excellence. We boast certified trainers with extensive industry experience, who are equipped to guide and mentor aspiring medical coders. We believe in fostering a supportive and collaborative learning environment where students can acquire valuable knowledge, build confidence, and achieve their career goals.

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us Your Role : Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who you are: Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

Role & responsibilities *Dispense medications to patients according to prescriptions and provide guidance on usage. *Maintain accurate records of patient interactions, including medication dispensed and dosage instructions. *Monitor inventory levels of pharmaceuticals and manage stock accordingly. *Provide counseling to patients about their medications, including potential side effects and interactions with other drugs. *Ensure compliance with regulatory requirements for handling controlled substances. Preferred candidate profile * D/B/M-PHARMACY WITH PCI CERTIFICATE.

Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelor's Degree In a Scientific or Healthcare discipline Req 3 - 4 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com