1738 Pharmacovigilance Jobs - Page 22

Pharmacovigilance Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Job Description Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines. Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures. Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate. Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting. Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements. Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations. Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated. Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units. Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases. Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections. Prepare for and represent the department in audits and inspections as designated. Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned. Coach and mentor less experienced associates in safety reporting or safety reporting intelligence activities and other work, as needed. Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned. Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects, as designated. Maintain understanding of applicable therapeutic areas and disease states as required. Travel (approximately 10%) domestic and/or international, as required. Perform other activities as identified and requested by management. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the 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. 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 relationship Ability to handle disputes Ability to manage multiple stakeholders Ability to meet deadlines Ability to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts

Designation: Pharma/Clinical/Scientific Recruiter Location: Noida Shifts: 7 PM to 4 AM IST 5 days of working, Saturday – Sunday fixed off Benefits – Pick and drop (free), Subsidized meals, medical insurance + recurring incentives Looking for a recruiter who can help us with Clinical, Scientific, and Engineering requirements such as: Scientific: Scientist, Research Scientist, Biologist, Analytical Scientist, Formulation Scientist, Computational Biologist, Data Scientist, Clinical Scientist, Clinical Research Scientist, Pharmacovigilance Scientist etc. Clinical: Drug Safety Physician, Medical Writer, Statistical/Clinical Programmer, Clinical Trial Manager, Clinical Site Manager, Medical Director, Payor Access Strategy / Market Access Researcher / Associate Director - Market Research/Market Access, Clinical Trial Physician, Clinical Trial Monitor, Medical Monitor, Clinical Research Associate, Clinical Trial Associate, Clinical Research Coordinator, Clinical Project Manager, etc. Engineering: Validation Engineer, Calibration Engineer CSV Engineer, Lab Equipment Engineer, Manufacturing Engineer, Cleaning Validation Engineer, Automation Engineer, Controls Engineer, etc. from our Pharmaceutical and Medical Device clients. This person will be working in an individual contributor capacity with limited supervision. Source candidates from various job boards such as CareerBuilder, Monster, Dice, Indeed and ZipRecruiter etc. using a variety of search methods to build a robust candidate pipeline. Roles & Responsibilities: Screen candidates by reviewing resumes and job applications and performing phone screenings. Set up interviews and facilitate the offer process by extending the offer. Take ownership of candidate experience by designing and managing it from start to finish. Ensure all screening, hiring, and selection is done in accordance with employment laws and regulations. Update daily activities in our internal ATS. Experience Required: 2-3 years’ experience working with Pharmaceutical and Medical Device clients. Educational qualification and Experience: At least a bachelor’s degree with a minimum 2 years of experience with W2 engineering requirements of pharma or medical devices clients such as BMS (Bristol Myers Squibb), Amgen, Sanofi, Novartis, Pfizer, BioMarin, AstraZeneca, Moderna, Bioclinica, Biegene, Iqvia, J&J (Johnson & Johnson), Genetec, Roche, Gilead, Merck, AbbVie, Biogen, Medtronic, Baxter, Stryker, Abbot, GE Healthcare, Bacton and Dickinson, Boston Scientific, and Alcon etc. Good communication and comprehension skills For more information about our company, please visit: www.compunnel.com Feel free to reach out at bhavya.joshi@compunnel.com/ 7073252678 in case of any queries.

We are Growing ! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization. Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry. Your role: Act as a primary or backup Medical Monitor for the assigned clinical studies. Oversee multiple studies, contribute to the regulatory submissions (INDs, etc.) Responsible for providing protocol/therapeutic training to the study team, as required. Provide medical expertise to investigators and study team and advise on medical related questions. Perform eligibility review of the study subjects, as required. Lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. Escalate any critical safety concerns to the study team and Sponsor, and coordinate between sites and study team/Sponsor. Responsible for identifying, reviewing and confirming protocol deviation classification Lead the Medical Monitoring and Protocol deviation project meetings, participate in any other Sponsor calls, if required. Work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, periodic safety reports. Responsible for the review of individual data with SAEs and potentially clinically important laboratory test results or vital sign abnormalities and escalate issues to the Sponsor as needed. Assist in medical and scientific review of deliverables such as TLFs and CSR. Lead in developing and maintaining SOPs, Templates, and study plans Participate in the review of the design and conduct of clinical trials including the development and review of protocols and amendments. Assist in incorporating medical strategy into study feasibility required for new projects. Cooperate with program development and commercial teams to develop the medical strategy for the RFP for new projects. Participate and lead medical strategy section in the Bid Defense preparation and meetings. Responsible for Line Management of assigned team members in Medical and Scientific Affairs group. Support regulatory inspections and audits as needed. Your Profile: Medical degree, MD or its international equivalent. Active medical license Fluent English (oral and written). Proven 5-7 years’ work experience within the life science industry or related field Minimum 4 years’ experience with medical monitoring services Strong understanding of GCP/ICH guidelines and applicable regulatory requirements Excellent verbal, written communication and presentation skills. Critical Thinking and background medical and scientific research Strong Proficiency in using Microsoft Office Experience with safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (Zelta, Medrio, Oracle Clinical, Medidata) Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the 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. 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 relationship Ability to handle disputes Ability to manage multiple stakeholders Ability to meet deadlines Ability to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts, Bachelor of Pharmacy,Master of Pharmacy

Sr. Medical Advisor - Diabetes Care POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. This is crucial in view of the complex marketing environment in India due to the presence of generic players and self-pay nature of the market. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with (if applicable) Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). Toenable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with Thought Leaders (TLs – Key HCPs). YOUR TASKS AND RESPONSIBILITIES: Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support development of marketing strategies with respective to competitor innovator and generic brands. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs, if applicable) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors and conduct refresher trainings at appropriate intervals. Support and educate internal customers in compliance with the Country’s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Medical/Scientific Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programs of the Business units within portfolio (included local studies OS, NIS, IIR). Identifies initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Graduate/ Post graduate degree (MBBS/MD) in life sciences is preferable. Experience and expertise in relevant TA’s or in industry is preferable. Experience in driving and managing the medical strategy for various brands in the pharmaceutical industry. Clinical research and trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, extrovert and dynamic Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Strong team player and know how to collaborate and engage many stakeholders across a large organization Innovative and pro-active and has ability of strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment. Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM I co-create in networks to leverage expertise YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 850077 Contact Us + 022-25311234

Medical Device Safety Physician – MBBS/MD mandatory. Review medical device safety reports (ICSR, SUSAR), assess risks, and ensure MDR/EU/US compliance. PV, clinical trials experience required. Required Candidate profile Strong decision-making, regulatory knowledge. WFO (Mumbai/Gandhinagar/Chennai/Pune/Indore). Salary up to 16 LPA.

Argus Configuration Specialist – Japanese Location : Noida, India Experience : Minimum 12+ Years Language Requirement : Business Proficiency in Japanese (JLPT N2 or Jetro or above preferred) Availability : Immediate Joiners Preferred Relocation : Candidates with the right experience and Japanese language proficiency willing to relocate to Japan will also be considered. About our client: Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. ​ Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets. Role Overview: We are looking for an experienced Argus Configuration Specialist with strong Pharmacovigilance system knowledge and Japanese language proficiency, ready to take on a leadership role in system architecture and configuration for our pharma clients in Japan. Key Responsibilities: Lead configuration, installation, validation, and customization of Oracle Argus Safety systems. Translate user and business requirements into technical specifications and configuration designs. Perform Business and System Configuration of Argus modules for both standard and custom workflows. Design, configure, and validate Aggregate Reports and Periodic Safety Update Reports (PSURs). Perform and support System Integration Testing (SIT) and User Acceptance Testing (UAT). Ensure compliance with international regulations and standards including 21 CFR Part 11, ICH, GxP. Liaise with Japanese stakeholders, bridging communication gaps with fluent written and verbal skills. Support global PV implementation or upgrade projects with emphasis on Japan-specific regulatory norms. Provide ongoing maintenance, upgrades, and technical documentation. Required Skills: 12+ years of strong experience in Argus Safety configuration and PV systems implementation. Proficiency in SQL / PL-SQL for data extraction and system customization. Strong knowledge of global PV regulations (FDA, EMA, MFDS, PMDA, etc.). Business-level proficiency in Japanese (JLPT N2+ highly preferred). Ability to join immediately or within a short notice period. Willingness to work onsite in Japan. Nice to Have: Experience with Japan-specific case processing or local regulatory submission formats. Prior work in cross-cultural project teams in APAC or global safety environments. Why You Should Apply: Global Exposure: Join a project with international impact and strategic importance. Language & Leadership Edge: Use your bilingual expertise to bridge technology and compliance. Impactful Work: Play a direct role in patient safety and regulatory excellence. Relocation Support: Exceptional candidates outside Japan with required skills and language proficiency are welcome to apply. How to Apply: If you have the Argus expertise, speak fluent Japanese, and are ready for your next big move—we want to hear from you! Please submit your resume and cover letter outlining your relevant experience and achievements in Argus Configuration Management within the pharmacovigilance sector. We look forward to reviewing your application and potentially welcoming you to our dynamic team dedicated to ensuring pharmaceutical safety and compliance. Equal Opportunity Employer Our client is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We offer competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development.

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: BE/BTech 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. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. What are we looking for? Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning 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

Job Title: Pharmacy & Store Incharge Company Name: Manipal Hospitals Location: Yelahanka Job Description: The Pharmacy & Store Incharge will oversee the daily operations of the pharmacy and store within the hospital, ensuring the proper dispensing of medications, management of inventory, and compliance with all regulatory requirements. This role requires effective coordination with healthcare professionals to optimize patient care and ensure the availability of pharmaceutical supplies. The individual will be responsible for managing pharmacy staff, ensuring accurate record-keeping, and maintaining a safe and organized environment. Responsibilities: - Supervise the pharmacy operations, including medication dispensing, inventory management, and stock replenishment. - Ensure compliance with legal and safety regulations related to pharmaceutical practices. - Collaborate with healthcare providers to ensure optimal medication therapy management for patients. - Maintain accurate and up-to-date patient records regarding medication prescribed and dispensed. - Conduct regular audits of pharmacy inventory and report discrepancies. - Train and mentor pharmacy staff to uphold best practices and standards. - Provide guidance on medication usage and answer inquiries from patients and healthcare staff. - Implement policies and procedures to improve operational efficiency. - Coordinate with suppliers for stock procurement and manage vendor relationships. Skills Required: - Strong knowledge of pharmaceutical regulations and standards. - Excellent organizational and management skills. - Strong interpersonal and communication abilities to interact with patients and healthcare professionals. - Attention to detail and ability to maintain accuracy under pressure. - Problem-solving skills to address operational challenges. - Ability to lead a team and foster a collaborative environment in the pharmacy. Tools Required: - Pharmacy management software for inventory control and record keeping. - Electronic health record systems for medication management. - Basic office software (e.g., Microsoft Office) for reporting and communication. - Inventory management tools for stock monitoring and procurement. - Safety and compliance software to ensure adherence to regulatory standards. This position requires a diligent and dedicated professional who is committed to delivering high-quality pharmaceutical care in a fast-paced hospital environment. Roles and Responsibilities About the Role: As a Pharmacy & Store Incharge at Manipal Hospitals in Yelahanka, you will oversee the daily operations of the pharmacy and ensure compliance with all regulations. You will be responsible for managing inventory, maintaining stock levels, and providing exceptional service to patients and healthcare professionals. Your role will also involve coordinating with suppliers and ensuring that all medication and pharmacy supplies are available as needed. About the Team: You will be working with a dedicated team of pharmacists, pharmacy technicians, and support staff who are committed to providing high-quality care to our patients. Collaboration and communication within the team are essential, as you will work together to ensure smooth pharmacy operations. The team values a patient-centered approach and fosters a supportive environment for professional growth and development. You are Responsible for: Managing all aspects of pharmacy operations, including inventory control and medication dispensing. Training and supervising pharmacy staff to ensure they adhere to policies and procedures. Maintaining accurate records and documentation in compliance with regulatory requirements. Implementing safety protocols and ensuring the pharmacy adheres to best practices in medication management. To succeed in this role – you should have the following: A degree in Pharmacy from a recognized institution and valid licensure. Previous experience in a pharmacy setting, preferably in a supervisory role. Strong understanding of pharmacy laws, regulations, and standards of practice. Excellent communication and organizational skills, with a focus on teamwork and customer service.

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

Oversight and management of Medical Review and Signal Management related activities Medical Review of Health Hazard Assessment and Knowledge sharing and training of DSRM team as required Signal detection and evaluation activities and Aggregate reports Medical review and approval of Individual Case Safety Reports and Providing inputs for MR Post Procedure Quality Check (PPQC) Review of relevant literature articles for aggregate reports and signal activities Supporting team in preparing device malfunction report and drafting response for Health Authority request Review of Quality investigation reports and Review and approval of case deletion form Review of any pharmacovigilance documents after relevant training as required and Provide inputs for SOPs and other guidance documents preparation Competencies 2. Innovation & Creativity 5. Result Orientation 4. Developing Talent 6. Process Excellence 7. Collaboration 8. Stakeholder Management Education Doctorate Graduation in Medicine Work Experience 5 to 10 years of Pharmacovigilance experience with preferred expertise in aggregate report, signal detection, clinical safety/SAE management

1 Responsible for lifecycle management of DSRM procedural documents in EDMS and non-procedural documents within due date which includes document creation, document revision, making document obsolete, making document effective, releasing document, sharepoint update and communication to relevant stakeholders 2 Responsible as SOP coordinator to perform roles as Author in edit step and QA authorisation in Release approval step 3 Responsible to perform role of Training Coordinator in Training step within EDMS as required 4 Oversight and management of compliance of DSRM training requirements and activities in LMS 4 Support and oversight of subsidiary Global PV training status as applicable 5 Oversight and management of Annual Basic PV compliance for India 6 Oversight on teams task completion, annexures, sharepoint updates and people management. 7 Creation of status presentations and other adhoc presentations as required People Management Competencies Strategic Agility Innovation & Creativity Process Excellence Customer Centricity Collaboration Stakeholder Management Developing Talent Result Orientation Education- Life Science Post Graduate, MPharm, BPharm, Work Experience Experience in Pharmacovigilance operations, Quality Management System, Training, Use of Systems for SOPs and Training Management

shroffsfoundation is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Job Description Preparation and Maintenance of Pharmacovigilance System Master file (PSMF) for Global, and other regional markets as applicable, including preparation of detailed description of Pharmacovigilance System (DDPS), summary of PV systems etc. Management of PV system master file(s) and regular updates of associated annexures for PV system Manage PV matters for subsidiaries and affiliates across the globe including but not limited to integration of pharmacovigilance and drug safety between DSRM and subsidiaries, development and formation of SOPs and procedures. Perform KPI monitoring and compliance monitoring activities for subsidiaries and other countries where Lupin does not have subsidiary but operates through local partners. Ensure Pharmacovigilance due diligence in matters of mergers and acquisitions. Coordination with vendors, internal and external stakeholders relevant for various DSRM functions Actively contribute to the development of processes, applications and methodologies in the department including continuous process improvement Education Post Graduation in Pharmacy or Pharmacy Work Experience Experienced candidate with 8 plus years of experience in relevant sphere of work which is subsidiary and affiliate management, along with experience of handling diverse PV system master files and global awareness on PV requirements across the globe. Competencies Result Orientation Customer Centricity Stakeholder Management Innovation & Creativity Developing Talent Process Excellence Collaboration Strategic Agility

Privacy and Data Protection Director LocationIndia (preferably Bangalore) Experience - 16+ yrs Role dimension The Wipro Privacy and AI Governance Team is a dynamic group committed to maintaining the highest standards in privacy, data protection, AI governance and ethics. We operate at the forefront of these critical fields, ensuring that our practices align with both legal standards and technological advancements. We are seeking a dedicated and experienced professional to join our team as a Privacy and Data Protection Director. Job Summary As Privacy and Data Protection Director, you will play a pivotal role in embodying our privacy and data protection strategies across the organisation. Your expertise will be critical in elevating the organisations privacy maturity, providing timely expert advice, enhancing internal procedures, flows and practices, enhancing team capabilities through training, and refining internal processes. You will serve as a trusted advisor, ensuring that our operations are compliant with legal requirements while leveraging technology effectively. You will also lead on transforming our privacy operations through streamlining, automation and efficiency. Key Responsibilities Trusted Strategic AdvisorLead the elevation of organizations privacy maturity and compliance posture, and act as the primary point of contact for privacy-related matters, providing expert guidance to various business units and stakeholders within the team and the wider organisation. Operations enhancement and automationDirect the review and operationalization of policies, processes to ensure they are current, relevant, and effective in evaluating privacy and AI related risks. Identify opportunities for streamlining and automating existing pathways. Team UpskillingDesign and implement training programs that enhance the team's understanding of privacy and data protection, specifically within the context of artificial intelligence and new technologies. Process ImprovementAnalyse existing internal processes and procedures related to privacy and data governance, identifying areas for improvement and leading initiatives for upgrade and compliance. Legal and Technology IntegrationServe as an innovative voice for the privacy function at the intersection of legal frameworks and technological developments, ensuring that our operations reflect both. Stakeholder EngagementCollaborate with cross-functional teams to ensure privacy considerations are integrated into business strategies, product development, and operational practices. Monitoring and ComplianceLead the development and implementation of privacy compliance initiatives, ensuring alignment with relevant regulations and frameworks. Qualifications: Proven experience in privacy and data protection roles in a senior capacity, whether as a privacy lawyer, head of privacy, senior risk professional or similar. Strong working knowledge of privacy laws and regulations, including GDPR, CCPA, PDPD and others relevant to our operational geographies. Experience in governance, risk management, and compliance within technology-driven environments, particularly relating to AI. Exceptional communication and interpersonal skills, with the ability to influence at all levels. Demonstrated ability to manage projects effectively and work collaboratively in a fast-paced environment. Advanced degree in law, information management, security or a related field is preferred. Why Join us At Wipro, you will be part of an innovative team at the forefront of privacy and AI governance. We value diversity, collaboration, and the growth of our employees. You will have the opportunity to impact how we approach privacy in a technologically evolving landscape, establishing standards that not only comply with regulations but also inspire trust in our clients and partners. Applications from people with disabilities are explicitly welcome.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Medical Information Specialist (MIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints. Essential Functions Include:Medical Information service delivery Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma’ s pharmaceutical clients. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices. Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems General Provides after-hours coverage on a rotated basis subject to business requirements. Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment. Complies with the Company’s health and safety policies. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Healthcare Professional, such as Nursing degree (RN/BS/BA/MS) OR Pharmacy degree Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills. Ability to write in a fluent and grammatically correct manner in the target language for the role English language proficiency. Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Analyst Qualifications: Any Graduation 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 Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designThe role will include research, industry-related topics (combining online sources, interviews and studies), writing clear marketing copies to promote products/services, preparing well-structured drafts using CMS/tools, proofreading & editing content before publication, coordinating with marketing and design teams to illustrate articles, conducting simple keyword research, using SEO guidelines to increase web traffic and identifying customers needs and gaps in the content and updating on website. What are we looking for Technical WritingMedical ReviewMedical MonitoringCreative DesignContent Curation 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 Any Graduation

K.K. Patel Super Speciality Hospital is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Analyst Qualifications: Any Graduation/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 2 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 •JLPT (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 Any Graduation,Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: Any Graduation/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 11 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 •JLPT (N3 to N5) 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 Any Graduation,Bachelor of Pharmacy,Master of Pharmacy

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Job Description We are looking for a Drug Safety Physician to provide medical and safety support to the activities of ICON Project Teams in order to ensure that projects are conducted according to the highest ethical principals and medical standards, in accordance with GCP and good pharmacovigilance practices and in compliance with applicable legal and regulatory standards. Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious) Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON and discuss the agreed approach on resolution with the client Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature Review and provide input to the Project Specific Procedures and participate in project related meetings Communicate with the client to an extent as described in the Project Specific Procedures Provide assistance in the preparation and conduct of code-break activities Review, asses and provide input to Product Information, Company Core Data Sheet and any other product related information as required by the client in the course of assigned project Provide input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event Other responsibilities as assigned Role Requirements Qualified and licensed physician with 2-3 years of patient diagnosis and treatment experience in a hospital-based setup. Prior experience in clinical research or pharmacovigilance (optional) Benefits Of Working In ICON Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Description Manager, Safety & PV (Japanese Language Professional) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcing's needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications Must be a N3 or above certified (JLPT) Japanese Language professional BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.