1738 Pharmacovigilance Jobs - Page 13

2 yrs CRC experience/ Bpharm, Mpharm/Bpharm,MBA qualification, fresher or intern in any pharmaceutical marketing/ Worked as Placement Coordinator for pharmacy college, Good Communication, Interpersonal analytical skills , establish Relationship with colleges, their placement cell, faculties, managing relationship with hospitals Doctors/investigators, handling grievance, helping out MD of company for developing patient data base, handling placement Drive event related things, establish follow up communication with CRO's/ Sponsor/hospitals IT companies regarding same.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. Job Function Description Jobs in this function provide coding and coding auditing services directly to providers. This includes the analysis and translation of medical and clinical diagnoses, procedures, injuries, or illnesses into designated numerical codes. *Employees in jobs labeled with ‘SCA’ must support a government Service Contract Act (SCA) agreement. General Job Profile Coordinates, supervises and is accountable for the daily activities of business support, technical or production team or unit Impact of work is most often at the team level Primary Responsibilities: Owns output at task level Work is generally limited to own function Sets priorities for the team to ensure task completion Coordinates work activities with other supervisors Develops plans to meet short-term objectives Identifies and resolves operational problems using defined processes, expertise and judgment Decisions are guided by policies, procedures and business plan Product, service or process decisions are most likely to impact individual employees and/or customers (internal or external) Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualification: Graduate degree or equivalent experience Values Based Competencies Integrity Value: Act Ethically Comply with Applicable Laws, Regulations and Policies Demonstrate Integrity Compassion Value: Focus on Customers Identify and Exceed Customer Expectations Improve the Customer Experience Relationships Value: Act as a Team Player Collaborate with Others Demonstrate Diversity Awareness Learn and Develop Relationships Value: Communicate Effectively Influence Others Listen Actively Speak and Write Clearly Innovation Value: Support Change and Innovation Contribute Innovative Ideas Work Effectively in a Changing Environment Performance Value: Make Fact-Based Decisions Apply Business Knowledge Use Sound Judgement Performance Value: Deliver Quality Results Drive for Results Manage Time Effectively Produce High-Quality Work At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission. #njp External Candidate Application Internal Employee Application

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. Primary Responsibilities: Lead a team of 75-90 certified coders. Maintains staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, and legal work environment; developing personal growth opportunities Performance Management – Timeliness, Quality and Productivity metrics Planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards Maintains quality service by enforcing quality and customer service standards; analyzing and resolving quality and customer service problems; identifying trends; recommending system improvements Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualifications: Graduate in any discipline Experience in Performance Management, Project Management, Coaching, Supervision, Quality Management, Results Driven, Developing Budgets, Developing Standards, Foster Teamwork, Handles Pressure, Giving Feedback Proven ability to use Microsoft Office Products (Excel, PowerPoint etc) Proven ability to operate basic office equipment (copier and facsimile machine) Preferred Qualifications: Graduate of Life science Certified Professional Coder / Certified Coding Specialist with 2 years coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission. #NJP #NTRQ External Candidate Application Internal Employee Application

We are seeking a proactive Analyst to support the development and validation of an AI/ML-powered pharmacovigilance product. This hybrid role requires a strong understanding of pharmacovigilance workflows, regulatory expectations/guidelines and the ability to translate those into system requirements and validation logic. You’ll also be involved in end-to-end functional testing, ensuring the product compliance. Key Responsibilities: Collaborate with the subject matter experts (SMEs) and the technical team to gather document functional and regulatory requirements for each module. Define and prioritize user stories, acceptance criteria, and data mapping specifications. Act as a bridge between business teams and technical teams to ensure alignment on product goals. Assist in regulatory compliance discussions and documentation. Perform testing and validation of the application to ensure it meets all the specified requirements and compliance. Validate data integrity, completeness, and compliance with safety reporting regulations. Required Skills & Qualifications: Experienced analyst who can perform a hybrid role of Business Analyst and QA Specialist for an AI/ML Product Familiarity with regulations and safety data standards. Proficiency in tools like JIRA, Confluence, and familiarity with Office / M365 tools. Experience in functional testing, validation and User Acceptance Testing (UAT). Excellent analytical thinking, attention to detail, and documentation skills. Nice to Have: Exposure to AI/ML product, especially with NLP and LLMs in healthcare. Experience working with AI/ML product requirements gathering or validating AI-generated data. Knowledge of validation frameworks. Educational Background: Bachelor’s or Master’s in Life Sciences, Pharmacy, Computer Science, Bioinformatics, or related discipline. Certifications with respect to domain or product development or BA or QA is an advantage. Job Type: Full-time Pay: ₹1,000,000.00 - ₹1,500,000.00 per year Ability to commute/relocate: Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Preferred) Education: Bachelor's (Preferred) Experience: AI in Life Sciences, Healthcare & Pharmacovigilance: 2 years (Preferred) Work Location: In person Speak with the employer +91 9310819196

Aster Medcity is looking for Senior 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.

Aster Medcity is looking for Senior 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.

Aster Medcity is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Dispense medications to patients as per prescriptions issued by physicians, ensuring accuracy and adherence to all relevant regulations and guidelines Educate patients about the proper use of medications, their potential side effects, and any other relevant information Maintain accurate records of all medication dispensing and patient interactions, as required by state and federal regulations Manage and maintain inventory of medications and other pharmaceutical supplies, ensuring appropriate storage and disposal of expired or unused medications Ensure compliance with all relevant regulations, including those related to dispensing and storing controlled substances Excellent communication, interpersonal, and customer service skills are required

Aster Medcity is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Dispense medications to patients as per prescriptions issued by physicians, ensuring accuracy and adherence to all relevant regulations and guidelines Educate patients about the proper use of medications, their potential side effects, and any other relevant information Maintain accurate records of all medication dispensing and patient interactions, as required by state and federal regulations Manage and maintain inventory of medications and other pharmaceutical supplies, ensuring appropriate storage and disposal of expired or unused medications Ensure compliance with all relevant regulations, including those related to dispensing and storing controlled substances Excellent communication, interpersonal, and customer service skills are required

Role Responsibilities: Assist in checking prescriptions and dispensing medication to inpatient and outpatient pharmacy patients. Handle patient queries regarding medications and provide relevant information. Ensure zero medication errors during dispensing and maintain accuracy in records. Perform stocktaking for near-expiry medications and manage returns to the vendor. Maintain inventory records, conduct stock checking, and ensure timely replenishment of supplies. Job Requirements: Graduate in Pharmacy or any related field. Understanding of pharmaceutical regulations and the ability to comply with regulatory laws. Ability to manage purchase and sale records of drugs, including cash register maintenance. Familiarity with clinical pharmacy practices and pharmacovigilance. Strong communication skills and attention to detail.

Aster Medcity is looking for Pharmacist.Pharmacy 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. Role: Pharmacist Industry Type: Medical Services / Hospital Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Other Hospital Staff Education UG: Any Graduate PG: Any Postgraduate

Aster Medcity is looking for Pharmacist.Pharmacy 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. Role: Pharmacist Industry Type: Medical Services / Hospital Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Other Hospital Staff Education UG: Any Graduate PG: Any Postgraduate

Job description Reviewing and evaluating adverse event reports to determine if they meet regulatory reporting requirements. Entering and maintaining adverse event information in safety databases Narrative writing Communicating with healthcare professionals and other stakeholders to gather additional information about adverse events Assisting in the preparation of safety reports to be submitted to regulatory agencies Monitoring safety literature to stay current on the latest safety information related to the products Collaborating with other departments such as clinical research, regulatory affairs, and pharma covigilance to ensure compliance with safety regulations and guidelines Participating in the development and implementation of safety policies and procedures Reviewing and assessing the safety profile of new and existing products Participating in the development and execution of risk management plans Communicating with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.

Company Information At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Company Culture Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives. At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact. Job Duties & Responsibilities Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol. Design and develop case report forms for clinical trial study protocols Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms. Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria. Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed. Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols. Location This role is open to candidates working remotely or hybrid in Bengaluru, India. Basic Qualifications 1+ Years of relevant experience Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research. Expected to work independently, as well as in a team environment. Good organizational and administrative abilities Familiarity with MS Office and various business software Preferred Qualifications Clinical trial coordinator at site Clinical data management Pharmacovigilance Records management Physical And Mental Requirements Sit or stand for extended periods of time at stationary workstation Regularly carry, raise, and lower objects of up to 10 Lbs. Learn and comprehend basic instructions Focus and attention to tasks and responsibilities Verbal communication; listening and understanding, responding, and speaking Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

Prior experience in monitoring adherence to compliance-based training programs. Demonstrated ability to influence and negotiate effectively. Ability to implement large-scale change in complex, matrix organizations Required Computer Experience: LMS administration and processing; proficiency in Microsoft Office, Adobe Acrobat, Sharepoint development and maintenance, course development products (Articulate, Storyline) and survey tools. BS – 7 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. MS – 5 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. Ph.D./PharmD/ MD – 3 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. Experience working globally with organizations/teams/individuals As the training development lead, work with stakeholders including global business and functional lines in support of Drug Development training and education. This includes cross functional study teams, functional area teams, vendors/contractors, and regional development areas. Key relationships include senior leaders and area experts.

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period; and may manage a team. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, lists/labeling, causality, adverse event coding and narrative review. Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing. Performs aggregate medical review and signal detection/analysis activities, as required. Actively engage with writing team to ensure quality and compliance SLAs are met through coaching, mentoring and timely feedback. Contribute to RFPs, case studies and white papers as and when required. Participate in client meetings and communications along with the Project team including Drug Safety Meetings and Signal Analysis Meetings, as required. Establish an excellent working relationship with the client medical team including managers/lead(s), as required. Work closely with pharmacovigilance colleagues (including Subject Matter Experts) to ensure appropriate medical interpretation and consistency are applied to aggregate reviews. And all other duties as needed or assigned. Qualifications (Minimum Required) Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level #+ or higher Writing / Reading: English at ILR level 4 or higher Experience (Minimum Required) At least 3 years of safety experience (case processing, medical review, clinical safety). Knowledge and understanding of regulatory requirements for Clinical Research/ Pharmacovigilance. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include At least 2 years of practicing medicine in a clinical setting. Aggregate safety experience (including aggregate medical review, signal detection and risk management). Physical Demands/Work Environment Travel Requirements: Regional. % of the time less than 5%. % of the above that requires overnight stay: 75% of above travel. Travel is primarily to where: Regional for client meetings. Learn more about our EEO & Accommodations request here.

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Job Description To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings To cooperate in the preparation of and provide input in Risk Management Plans Supporting the preparation of responses to regulatory authority requests Signalling Reviewing line listings Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation Evaluating and categorizing possible signals and proposing a course of action Supporting preparation and review of benefit-risk reports Qualifications The PV Physician should be medically qualified as a physician Previous experience in pharmacovigilance Ability to review different aggregate report types including PBRERs and DSURs Expertise in signal detection activities is essential Excellent interpersonal skills Ability to plan, organise, prioritise and execute multiple tasks Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork Communication skills Presentation skills English - advanced (spoken, written) Advanced literacy (MS Office) Additional Information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets. Manages and leads a team of professionals in pharmacovigilance and collaborates with IPS Leadership and Heads of Patient Safety in Countries, to ensure an effective model is in place to support PV activities within the scope of IPS HYD. In addition, this role is responsible for leading, overseeing or executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader. Provides leadership and direct line management to IPS team members based in HYD. Contributes to the design and implementation of an effective IPS operating model in HYD to support in-scope PV activities for IPS, spanning multiple geographies and liaising with multiple Heads of Patient Safety, in applicable countries. Collaborates and supports cross-functional teams to ensure effective conduct of PV activities. Leads the ideation and continuous process improvements with the HYD team, to bring incremental business value-add benefit (increase quality, efficiency, consistency) and fully leverages available technology. Leads cultural awareness and ways of working within the HYD team to enable effective ways of working across multiple cultures and geographies. Provides feedback to IPS Leadership on the performance and effectiveness of the IPS operating model in HYD, to ensure its continuous improvement. Addresses any issues or challenges, with clear action plans, on any activity performed within the IPS operating model in HYD. Leads IPS HYD team communications and interactions locally (e.g. team meetings and connections with other PS teams). Leads the planning or contributes to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support/Lead Aggregate Report related activities. Lead the creation/update of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets. Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators. PV activity planning and tracking e.g. signal communications to Health Authorities. Collaborate and support cross-functional teams to ensure effective conduct of PV activities. PV Audit and Inspection support (including preparation, conduct and follow-up actions.) The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required. Functional and Managerial reporting lines into IPS. Excellent interpersonal, verbal, and written communication skills, with the ability to effectively engage across different geographies and cultures. Experience working across cultures and geographies is therefore highly desirable. Solid understanding of pharmaceutical organizations and their structures and pharmacovigilance systems. Able to research, compile and provide safety information in a clear, concise manner. Subject matter expertise in PV legislative matters such as global, regional and any other relevant legislation/guidance regarding PV (e.g., FDA, EMA, ICH, CIOMS). Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines. Utilizes effective problem-solving approaches to address PV issues, leads discussions on process improvement opportunities and co-solutioning with Leadership. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability. Previous line management responsibility, with demonstrable experience in developing talent. Operational Skills: Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows. Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods. Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams. Analytical Skills: Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data. Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments. Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality. Strategic Skills: Strategic Thinking: Integrates a diverse array of digital technologies digital strategies to enhance cross-departmental processes and medium-term PS objectives. Decision-Making: Uses multiple data sources and AI generated predictions to support decisions Change Management: Drives digital change initiatives, managing stakeholder expectations and overcoming resistance. At least 5 years' experience in the Pharmaceutical Industry, with a minimum of 3 years' experience working in Pharmacovigilance or in a closely aligned field (e.g., Regulatory, Clinical or Medical Information). University degree (health or life science) or nursing qualification. Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency) Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Overview Provide leadership for Lifecycle Safety, Service Operations (SO), developing cross-functional integrated delivery plans for safety operations throughout all stages of the Lifecycle Safety opportunity chain. Provide leadership for a combination of designated Lifecycle safety operations service lines and direction for specified accounts. Participate actively in local and global initiatives, as needed. Provide line management for assigned staff who are deployed in Service Operations. Primary point of contact for assigned customers or account Essential Functions Accountable to monitor and track project financials/ budget to ensure agreed margins are maintained Independently engage assigned customers on escalation, scope expansion and look for additional business opportunities Lead a high quality and efficient Service Operations team. Develop and review the team reporting structure for IQVIA while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations. Accountable to meet all project specific SLA and KPI’s Direct and support operational decisions in collaboration with senior management. Ensures financial project performance through oversight of key performance metrics. (revenue, direct costs, time-sheet costs, utilization and realization). Act as mentor and coach to less experienced managers, as appropriate. Lead and support ongoing overarching operational, strategic and tactical initiatives as assigned/ agreed, ensuring timely and complete delivery. Direct project resource assignments including staff hiring, and training in collaborations with senior management. Direct and/or participate in cross-functional teams and other process improvement initiatives. Lead and anticipate actively in local and global initiatives, as needed. Support in designing functional strategy Demonstrate and cascade the organizational vision and mission, core values Ability to independently participate in Request for proposal (RFP) and bid defense Ability to represent IQVIA in various industry forums and conference as required Qualifications Bachelor's Degree Scientific or healthcare discipline or allied life sciences Bachelor’s degree in health science or related area, and 15 years experience in Contract Research Organization or Pharmaceutical company or life science services company, including 10 years of experience in managing a workforce of up to 400+ employees, operating with senior/executive management teams or equivalent combination of education, training and experience. Ability to clearly articulate to large group and build consensus. Ability to address large audience during townhalls and other external forums. Excellent interpersonal skills, effective communication. Engagement with global delivery hubs. In-depth knowledge of Safety service lines. willingness to increase knowledge across Safety service lines and develop new skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Ability to work on multiple projects and manage competing priorities. Effective mentoring and developed coaching skills. Excellent presentation, report writing skills and customer focus skills. Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities. Sound judgment, decision-making and problem solving skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to support in drafting SOP, Operation, Technical Project documents. Ability to understand and analyze performance Metrix and numbers to support operations. End to End Project management exposure. Excellent team leadership and customer services skills. strategic customer focus. Strategic understanding of business processes across opportunity chain and all phases of product lifecycle. Strong analytical, judgment and decision-making skills. Strong innovation/solution skills. Strong communication (written and verbal) and presentation skills. Strong problem-solving, influencing, negotiation, conflict management and collaboration skills. Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment. Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics. Demonstrated flexibility, initiative, proactivity, ownership and accountability. In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines. Strong ability to establish and maintain effective working relationships with coworkers, managers and customers. - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. Flexibility to support in global time zones as required. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Should have knowledge in Clinical Data Managemen Should have good knowledge in edit checks crf design SAE Reconcilation crf annotation Good knowledge in Startup conduct phase and close out phase Required Candidate profile Strong understanding of clinical data management and E2b Guidelines Excellent clinical assessment and Communication Skills

Urgent Clin Infotech Hiring B.Pharm Freshers With Certification in Clinical Research and Clinical Data Management Candidate With Hands On Experience In Clinical Data Management Is Preferrable Required Candidate profile Candidate With Knowledge in Clinical Research Roles and Responsibilities is Prefferable Candidate Should have Good Communication Skills is Mandatory

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 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. . 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 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. 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

Position description: Officer-Employee Engagement Primary Responsibilities: Business Financials Lead Engagement Liaison with Business to understand their manpower requirement priorities resourcing accordinglyResponsible to provide trained manpower to Business and is productive within 3 weeks of joining to the respective locationOne to one interaction with individual staff for their queries Managing Low Performers PIP Responsible for executing engagement interventions to enhance Trust IndexTo coordinate and evaluate the effectiveness of the workforce engagement strategyTo establish benchmarks and targets against which future improvements can be madeHiring CRO FIO other supporting vertical as well with in TATCustomer Both Internal ExternalEducate Branch staff about all policies processes adhered amended by Ujjivan from time to timeAct as a catalyst between branch employees HR to make Ujjivan best place to work Conflict management Address issues in the field in full coordination with the line managers Establishing Rapport with the branch Staff provide early feedback on any issues of dissatisfaction especially in the area of local supervision management Career Advancement Plan Motivating employees on the opportunities across the region handholding and ensuring the implementation of orientation plans at the branches post training Managing End to end employee life cycle and give handholding to employeesState Cluster Level owner of execution of the employee engagement activities and measure the outcomes activities includes regional festival employee anniversary gifts family connect plan sports tournament Organizing Health Medical checkup Camps for employees Make Suring full final settlement is on time Branch clearance Supervisor clearance SHR clearance IT assets Ensuring confirmation as per process and helping concern supervisor to follow the process Sharing payroll input to concern person within 100 efficiencies Following up with supervisor to completion probation appraisal is on timeHandling as a regionalcluster spoke for sharing confirmation data with corporate team or business spoke Daily resignation tracker head count signs off etcInternal Process Regular Coordination with RLT on Issues for resolutionsMin 13 branch visits in a month All branches to be visited in one quarter Acting as an independent advisor for employees in tough situationsMaintain a track of one to one interaction with branch staff solution counsel their issues Regional priorities and executing variance stage of branchesbranch employee eg EPFO data correction KYC updation various MIS etcHelping people understand the value of their individual contributionsImproving communications Recognizing good workInnovation LearningEnsure that all members of the Branch staff are up to date on all relevant circulars and Benefits offered to themAssisting adherence to training mandatory training programs for branch staffscompletion Mandatory course on SwayamEnsure adherence to training mandays mandatory training programs for branch staffCoordinate with Distribution Concern teams on people related matters support branch activities to foster teamwork and continuously make Ujjivan a great place to work

We are seeking an experienced Drug Safety Coding Specialist with a strong background in pharmacovigilance terminology and regulatory coding standards. Roles and Responsibilities Perform accurate and consistent coding of adverse events , medical history, lab terms, and concomitant medications using MedDRA and WHO-DD. Review and validate terms in Individual Case Safety Reports (ICSRs) to ensure alignment with global PV standards. Perform recoding or dictionary version updates in compliance with regulatory requirements. Collaborate with case processors, medical reviewers, and data management teams to resolve coding discrepancies. Ensure compliance with ICH-GCP , GVP , and internal SOPs. Maintain and update code lists and contribute to coding conventions development. Support training of new team members on dictionary use and coding best practices. Participate in audits, inspections , and quality control checks related to coding. Qualifications B.Pharm / M.Pharm / PharmD / MBBS / BDS / B.Sc. Life Sciences MedDRA coding training or pharmacovigilance certification is a plus Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/WhatsApp to 9342735755

Roles and Responsibilities Prepare and review high-quality aggregate safety reports for regulatory submissions. Author and update Risk Management Plans, Core Safety Information, Company Core Data Sheets, and Safety Narratives. Collaborate with global cross-functional teams including pharmacovigilance, medical affairs, regulatory, clinical, and biostatistics. Interpret and summarize safety data from various sources including clinical trials, real-world evidence, and post-marketing surveillance. Track timelines and ensure timely delivery of all safety documents. Qualifications PharmD / M.Pharm / MBBS / BDS / MSc in Life Sciences or Pharmacology Certification in medical writing, regulatory affairs, or pharmacovigilance is an added advantage Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/WhatsApp to 9342735755

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to work well in a teamAgility for quick learningAdaptable and flexible Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing