1738 Pharmacovigilance Jobs - Page 34

Job Title: Local Case Intake Advisor - Global Business Services Career Level - C Introduction to role: 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. Youll 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 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 23-Jun-2025 23-Jun-2025

Job Title: Local Case Intake Advisor (Thai Language) - Global Business Services Career Level - C Introduction to role Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards. Accountabilities Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs). Review, assess, and process safety data from various sources, distributing reports to internal and external third parties. Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting. Provide prompt support for regulatory authority queries related to the Patient Safety function. Implement Corrective and Preventative Actions in the event of local non-compliance. Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received. Periodically screen regulatory authority databases for adverse events. Perform literature search and related activities for MC product portfolio if required. Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts. Maintain filing and archiving practices of patient safety documents. Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready. Support external service providers to meet company and local regulatory PV requirements. Assist the local PS team in audits or regulatory authority inspections. Complete all required patient safety trainings and obtain access to relevant systems. Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety. Essential Skills/Experience Degree Qualified - Pharmacy/ Medical/ Science Language skill - Thai 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 23-Jun-2025

Engaging with and taking care of customers, dispensing the right medicines as per the prescriptions, ensuring optimal availability of drugs, purchasing, returning and safekeeping the physical stock of medicines including regular screening for expiry of drugs, complying with the provisions of D&C Act and other related Acts, Negotiating, and dealing with suppliers etc

Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product s safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Line manage a team of regionally based physicians performing the tasks of a global medical safety physician ensuring operational delivery of assigned projects and professional development of direct reports Participate in the Global Medical Safety Management Team to drive service line growth, differentiation, and strategy Represent global medical safety service line to regional stakeholders, internal and external Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the teams utilization rates; the direct reports training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. Create and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment. Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. Prepare, present and respond in bid defense meetings and discussions. May input into more complex requests for information (RFIs) or requests for proposal (RFPs). Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients. Contribute at IQVIA internal cross-functional project team meetings interfacing with other functional leads customer project status meetings and oversight group meetings. Subject Matter Expert (SME) Meetings, as appropriate. Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Strong business acumen; financial management and budgeting skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Strong project management; strategic planning; delegation and organisational skills. Proven ability to work on multiple projects and manage competing priorities. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations. Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues. Excellent communication (both verbal and written), presentation and negotiation skills. Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level. Autonomous independent decision-making; problem solving and judgment skills. Strong customer focus; account and alliance management and experience in customer contracting models. Proven ability to professionally network; present and lead at meetings/ teleconferences. Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities. Demonstrate excellent flexibility; self-motivation; creativity; innovation and solutions driven approach. Demonstrates financial awareness. Promotes good practices to manage financial performance Strong ownership skills: take initiative and move forward with limited guidance. A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Clove Dental is looking for Oral Surgeon Professional to join our dynamic team and embark on a rewarding career journey A surgeon is a medical doctor who specializes in performing surgical procedures to treat injuries, diseases, and deformities through operative techniques Surgeons undergo extensive training, typically completing medical school followed by a residency program focused on surgery They possess advanced knowledge of human anatomy, physiology, and medical technology Surgeons work in various specialties such as general surgery, orthopedic surgery, neurosurgery, cardiovascular surgery, and more Their responsibilities include diagnosing patients, planning and performing surgical procedures, collaborating with other medical professionals, and providing post-operative care Surgeons require excellent technical skills, decision-making abilities, and communication skills to effectively manage complex medical conditions and ensure the best possible outcomes for their patients

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following: Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

Business Unit PSL Product Team – Corporate, Institutional & Investment Banking PSL Product team takes care of entire priority sector lending portfolio for Corporate, Institutional & Investment Banking group. PSL product team is responsible for Identification, classification and reporting of Priority Sector book. The team is also responsible for working out structuring for various PSL deals in close co-ordination with Business units. Role PSL Product Manager Objective To drive Priority Sector Lending business, ensure accurate classification and reporting of PSL assets in Wholesale banking business Responsibilities PSL Reporting, PnL Management & Portfolio Management Ensure PSL reporting is completed timely and in adherence to extant regulatory guidelines and updation of Product notes or assigned products in line with change in regulations/RBI/SIDBI/Ministry of MSME etc. Managing the PSL portfolio of Wholesale banking and internal/external audits for this portfolio Drive projects for digitisation/ automation of PSL reporting Manage PnL for PSL portfolio of Wholesale banking Driving PSL Book Growth Drive PSL book growth for WBG organically & inorganically by way of Corporate linked PSL structure, securitization / on-lending etc. Generate vendor Financing and Agriculture PSL leads. Meet clients, structure PSL deal and conclude the same in close co-ordination with Relationship Team Prepare Program note incorporating PSL complaint structures and arrange approval from requisite sanctioning authority To execute client/ vendor (Farmer level) documentation in close co-ordination with on filed SeSo official and/or Business Correspondent Review PSL process note for process upgradation from time to time Due Diligence Conduct due diligence of PSL proposal post disbursement, by sample audits based on requirement. Drive PSL - to build mindshare towards PSL: Explore PSL opportunities in corporate banking Conduct trainings & reviews with Business team Experience CA/ MBA with 3-6 years of experience. Some experience in similar field is added advantage. Essential competencies - Flair to work in Priority Sector Lending Group - Good communication skills - Ownership, Result oriented , growth mind-set. Base Locations Kotak Mahindra Bank Mumbai

Role – Team member – Compliance Experience – 5 years Grade – M5/M6 Qualification – CA/MBA Keeping track of updates in regulatory guidelines applicable to company, assess the impact on processes/policies and ensure implementation of changes. Driving compliance culture in organization and ensuring compliance with existing RBI guidelines Advising Business/credit on compliance related matters. Providing clarification to various stakeholders on compliance queries Maintaining policies of organization and ensuring periodic review of same as per regulatory/internal guidelines Submission of periodic RBI returns and responding to ad-hoc RBI data requirements Liaise with group company on compliance related matters and submission of periodic/ad-hoc data to group company Performing compliance reviews for different departments and periodical test checking of Internal Controls of the company Monitoring the compliance system of company and ensuring compliance of respective stakeholders on timely basis in system One point of contact of RBI and managing Internal/Statutory audits and RBI Inspections.

Job Description - Diabetes Educator! Company Name: Kartavya Healtheon Pvt Ltd Contact Number: +91 77009 05394 Experience Required: 1-3 Years Location - Bhuj ,Gujarat Company Overview: Kartavya Healtheon is a Mumbai-based B2B healthcare company dedicated to enhancing patient engagement. Our services encompass organizing in-clinic camps, facilitating patient support programs, and managing specialty pharmacy services. Our mission is to make healthcare accessible for everyone, regardless of location. We are currently partnering with a pharma client to provide essential diabetes education and support to patients. We seek a skilled and compassionate Diabetes Educator to join our dynamic team. Job Overview: The Diabetes Educator will play a vital role in educating and supporting patients with diabetes, empowering them to effectively manage their condition. This position involves working in doctors' clinics and hospitals to provide patient education, counselling, and program enrolment support. Responsibilities: Conduct educational sessions and counseling for patients in doctors' OPD clinics and hospitals regarding diabetes management. Demonstrate insulin pen usage and other diabetes management tools to patients. Build rapport with patients by addressing their queries and concerns effectively. Direct patients to approved pen stations for their convenience. Follow up with patients to monitor therapy initiation and assist with any challenges they encounter. Enroll patients into the program and maintain accurate records in the CRM system. Organize camps and support initiatives in collaboration with healthcare providers. Ensure adherence to pharmacovigilance protocols and compliance guidelines for patient safety. Provide feedback and report to the Reporting Manager on program effectiveness and patient outcomes. Requirements: Bachelor’s degree in a relevant science field, or qualification as a dietician, or certification as a diabetes educator, with 1 to 3 years of experience in pharmaceutical or allied services, or diet counseling. Strong passion for diabetes education and patient support. Exceptional communication and interpersonal skills. Ability to work independently, manage time efficiently, and maintain flexibility in work hours, including evenings and weekends as necessary. Positive attitude, willingness to learn, and a friendly demeanor. Working Conditions: The Diabetes Educator will work in various settings, including doctors' clinics and hospitals as per roster provided by reporting manager. Flexible working hours, including weekends and holidays, may be required. Note: This position is part of a program for one of our pharma clients, and the selected candidate will be employed by Kartavya Healtheon Pvt Ltd. This job description serves as a general outline of responsibilities and requirements for the position. It is not exhaustive, and additional duties may be assigned based on business needs.

Job Title - S&C Global Network - AI - Healthcare Analytics - Manager Management Level: 7-Manager Location: Bangalore/Gurgaon Must-have skills: R,Phython,SQL,Spark,Tableau ,Power BI Good to have skills: Ability to leverage design thinking, business process optimization, and stakeholder management skills. Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Provide strategic advisory services, conduct market research, and develop data-driven recommendations to enhance business performance. WHATS IN IT FOR YOU An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 8-12 Years Educational Qualification: Bachelors or Masters degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or other Quantitative field.

Job Title - S&C Global Network - AI - Healthcare Analytics - Manager Management Level: 7-Manager Location: Bangalore/Gurgaon Must-have skills: R,Phython,SQL,Spark,Tableau ,Power BI Good to have skills: Ability to leverage design thinking, business process optimization, and stakeholder management skills. Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Provide strategic advisory services, conduct market research, and develop data-driven recommendations to enhance business performance. WHATS IN IT FOR YOU An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 8-12 Years Educational Qualification: Bachelors or Masters degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or other Quantitative field.

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 priorities.Flexible 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 Word.Business 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: 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 priorities.Flexible 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 Word.Business 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: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 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: Clinical Database Developers: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

Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : SAP PP Production Planning & Control Discrete Industries Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Roles & Responsibilities:- Expected to be an SME, collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Collaborate with stakeholders to identify and document business requirements.- Design and implement business processes and workflows.- Analyze existing processes and identify areas for improvement.- Develop and maintain process documentation and standard operating procedures. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP PP Production Planning & Control Discrete Industries.- Strong understanding of business process analysis and design.- Experience in defining product requirements and use cases.- Knowledge of process improvement methodologies such as Lean or Six Sigma.- Experience with process modeling tools such as ARIS or Visio. Additional Information:- The candidate should have a minimum of 12 years of experience in SAP PP Production Planning & Control Discrete Industries.- This position is based at our Chennai office.- A 15 years full time education is required. Qualification 15 years full time education

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical data svs analyst Qualifications: BE,BTech,MCA Years of Experience: 3-5 yrs 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, Clinical Automation, 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 Automation Team focuses on the development and implementation of innovative concepts and application for out clients across different accounts in Operations. The team is responsible for designing and implementing highly interactive, scalable web apps and prototypes at Enterprise level. The team is responsible for collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, C# or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamBachelors degree in computer science, Information Technology, Engineering or any computer related discipline.Work experience of at least 3 years in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.).Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions.Work experience in Implementing APIs based architecture frameworks.Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment.Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations.Design and implement highly interactive, scalable web apps and prototypes at Enterprise level.Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly.Implement APIs based on architecture frameworks and guidelines.Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines.Able to lead Automation initiatives within his account.Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution.Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain.Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You should be able to pilot and deploy automation solutions at scale.Partner with the testing team to ensure applications/components are fully functional.Oversee and fix any defects or performance problems discovered in testing.Participating in analyses of requirements as well as functional design whenever necessary.Be involved in the design of the solution.Performing design, coding, application maintenance and testing activities.Take ownership of the successful implementation of the solution.Interact with the end client as required to ensure the solution is implemented as per requirements.Deliver code to time and quality expectations.Fully unit test developed solutions. Qualification BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Database Programming 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 and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Job Title - Life Sciences- Clinical Management Level : 9,11 Location: HYD, BLR, GGN, MUM; Must have skills: Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite Good to have skills: Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials Job Summary : MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Roles & Responsibilities: Together, lets deliver more effective, affordable, personalized patient outcomes. In this practice, youll help drive our Life Sciences clients strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with clients business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Professional & Technical Skills: Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication, interpersonal and presentation skills Additional InformationWhats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word come and be a part of our team. About Our Company | Accenture Qualification Experience: 3+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Educational Qualification: MBA from a Tier 1 institute or rich relevant industry experience

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Service Delivery Ops Specialist Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 7 to 11 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 "Aggregate Safety Report ScientistAggregate Safety Report Scientist" Roles and Responsibilities: "In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts" Qualification Bachelor of Pharmacy,Master of Pharmacy

Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred #LI-REMOTE

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 Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER) and Clinical Expert Statements. Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future risk minimisation activities for the entire life cycle of the product. Reviewing the documents, checking for completeness and consistency, and evaluating the report quality. Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc.). Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit balance. SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training. Development of customer-specific solutions and processes in cooperation with clients. Build, develop and maintain working relationships with clients. Ensure client satisfaction and compliance with legal and regulatory requirements. Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project. Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date. Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies. Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department. Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of scope activities that affect project invoicing. Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs and solutions, Leadership and coaching of employees; Conduct of probation period, annual employee feedback and goal setting meetings, Identification of training needs for employees to help them perform and grow in future role. The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required. . Experience: Minimum 4 Years in writing Risk Management Plans, Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER) and Clinical Expert Statements. Qualification: B.Pharm/M.Pharm Open to work from Noida location 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

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 Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Responsible for quality management, workload management, compliance management and document management for the assigned PV projects Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow‐up requests Submission of ICSRs to Health Authorities and partners of a client Acts as line manager of assigned staff Manages project coordination and resource allocation within the projects Train and mentor PV department staff, as needed Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis Responsible for recruitment of new staff in PV Department Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs Is involved in goal setting and annual appraisals of staff Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals. Ensures training compliance by PV staff at all times Represents PV department during for-cause/maintenance client audits or regulatory authority inspections Ensure compliance with internal standards and external (national and international) regulations To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects To organize and perform training of the above-mentioned documents Case processing including data entry and QC Case completion / documentation. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. . To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects To organize and perform training of the above-mentioned documents Case processing including data entry and QC Case completion / documentation. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. 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

Job Title - Safety Aggregate Report Specialist 2. Skills required - Signal detection/Signal Management. Years of exp required - 4+ yrs exp in Signal Mgt. Work location - Anywhere in India. Work Mode - Hybrid/Remote. 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. • 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 characterization 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. investigators, medical monitors, site coordinators and designees to address project related issues. • Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. • To liaise with client in relation to details on day to day activities as needed. • Contribute to achievement of departmental goals • Perform other duties as assigned