1759 Pharmacovigilance Jobs - Page 43

Supriya life science ltd is looking for Research Scientist - FRD (Injectable) to join our dynamic team and embark on a rewarding career journey. Research Planning : Develop and design research projects, experiments, and studies to investigate specific scientific questions or problems. Create detailed research plans, including methodologies, timelines, and resource requirements. Data Collection and Analysis : Perform experiments, gather data, and conduct data analysis using various scientific methods, statistical techniques, and specialized equipment. Interpret and evaluate the results to draw meaningful conclusions. Literature Review : Stay up - to - date with relevant scientific literature and research developments in the field. Analyze existing research to identify gaps and opportunities for further investigation. Hypothesis Testing : Formulate hypotheses and test them through experimentation. Analyze the outcomes to validate or invalidate the hypotheses. Innovation and Problem Solving : Utilize critical thinking and creativity to devise new approaches to scientific challenges. Propose and develop innovative solutions to complex problems. Collaboration : Collaborate with interdisciplinary teams, researchers, engineers, and other stakeholders to exchange knowledge, ideas, and expertise. Participate in discussions and contribute to group projects. Presentation and Communication : Present research findings to both technical and non - technical audiences through reports, presentations, scientific papers, and conferences. Effectively communicate complex scientific concepts in a clear and concise manner. Safety and Compliance : Adhere to safety protocols and ethical guidelines in conducting experiments and handling hazardous materials. Ensure compliance with all relevant regulations and institutional policies. Equipment Maintenance : Maintain and troubleshoot laboratory equipment to ensure accuracy and reliability in research activities.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc. ) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. ) Mentoring and training of new and more junior employees within the department, including procedure optimization and development

Work Schedule Environmental Conditions PURPOSE OF THE FUNCTION Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements. Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations Roles And Responsibilities Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting Coordinates with and supports deliverables with GPS GSL team in relations to case processing Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes Communicates with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA). Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication Proactively identifies issues and areas for improvement and escalates appropriately Proactively engages in the development of new processes and procedures and leads implementation of those Performs all activities in compliance with applicable Controlled Procedures and with global and local regulations as applicable. Performs other tasks as assigned by line manager or Head of GPS Skills And Competencies Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan) Proficiency with safety database systems (i.e. Argus) and MedDRA coding Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio Communicates complex issues in an understandable, effective and relevant manner Manages and prioritizes a variety of tasks for self and team to meet required deadlines Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk Identifies complex problems, raises issues and proposes solutions constructively Proven ability to communicate effectively and collaborate successfully across functions and with vendors Advanced communication in written and spoken English required Education, Experience And Qualifications Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field Must have JLPT N2 or above level certification At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US) Must have worked on PMDA PV related activities Should have hands on experience in managing resource who are working in PV case processing with Japanese Language Proficiency Advanced expertise of global (EU/US) pharmacovigilance requirements and practices Advanced experience with safety database systems (ARGUS preferred) including workflow management Proven experience in interaction with 3rd party vendors Proven experience with the identification of quality issues and evaluation of quality metrics Willing to work in Japan Timezone Show more Show less

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 and/or case report forms design to meet with pre-determined quality criteria Participate in customer interactions over the e-mail to assimilate customer requirements and address those adequately in the design and development of calendars and case report forms Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols Monitor the team performance, timeliness and quality Work with Managers to help manage performance management of their team Work with the QC team to understand learning gaps for their team and develop a learning plan Manage communication with customers Location This role is open to candidates working hybrid in Bengaluru, India. Basic Qualifications Graduate-Life Sciences, BCA, MCA, BE- Biotech or equivalent experience 4+ years’ work experience in job areas such as: Clinical data management Clinical trial coordination at site Pharmacovigilance Clinical research associate Records management Sound 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 Excellent organizational and administrative abilities Ability to liaise with key stakeholders across the organization Familiarity with MS Office and various business software Preferred Qualifications Highly personable nature that fosters teamwork Excellent communication skills – oral as well as written High energy and positive attitude towards working in a culturally diverse environment A passion for ensuring outstanding customer support with a solutions-oriented attitude. Proactive and takes ownership in all tasks from start-to-finish. 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. Show more Show less

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 documents to extract the required information for various tasks. Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) to utilize related functionalities in the design, development, and support of various services. Ensure that projects are completed in accordance with agreed-upon requirements by working with the project managers and the internal team. Ability to review and repurpose existing content to optimize effectiveness and productivity. Ability to work within cross-functional teams and verbally communicate ideas and information. Problem-solving and resolution of issues/bugs, quality, and detail oriented. Work closely with the reporting manager to complete daily/ weekly tasks to meet pre-determined quality criteria. 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 hybrid in: Bengaluru, India. Basic Qualifications Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research. Aware of professional/clinical trial industry standards, in particular excellent knowledge of ICH GCP required. 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: 0–2-year work experience in job areas such as: Clinical trial coordinator at site Clinical data management Pharmacovigilance Records management Preferred Qualifications Highly personable nature that fosters teamwork Excellent communication skills – oral as well as written High energy and positive attitude towards working in a culturally diverse environment. A passion for ensuring outstanding customer support with a solutions-oriented attitude. Proactive and takes ownership in all tasks from start-to-finish. 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. Show more Show less

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills: Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge and Experience : Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education: Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

Job title: Global Pharmacovigilance Workflow & Oversight Manager Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities Responsible for maintaining case workload in CHAMPS (PV Database (DB)/LSMV) and ensuring the case timelines are within CHAMPS are met. Ensure to a maintain healthy Work in Progress (WIP) case load for Opella. Responsible for maintaining business architecture diagram (all modules in LifeSphere). Responsible for maintaining configurations for LSR tool. Maintain LSMV (CHAMPS) user manual with current SOPs/regulations and case processing conventions. Responsible for trending analysis and alert the case management head for any abnormal increase/decrease in case volumes Responsible for monitoring Capacity utilization of the resources. This role will regularly engage with multiple vendors in different roles and capabilities related to Case Management (CM). This role works cross functionally with internal Opella departments and external resources on ICSR and safety DB related matters. This role will lead and define optimal business models to support business goals and ensure the operational model meets defined strategic key performance indicators (KPIs) crucial to business success for case processing vendor. Ensure optimized process are deployed for ICSR receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution, and submission in compliance with SOPs/regulations. Provide ongoing oversight to ensure a consistent and compliant approach to understanding Opella PV needs and focus on continuous improvement to identify efficiencies. Maintains operation reports from LifeSphere Reporting & Analytics (LSRA)/ LifeSphere Multivigilance (LSMV) and ensures the implementation of effective CAPA plans for identified deviations in CM activities. Support QC lead and work closely with SMEs and Quality Assurance (QA) to improve and exceed quality standards, to identify process improvements and to ensure CM resources have necessary training and skills. Responsible to ensure training slides and attendance sheets for all PV trainings. Assists in CHC case migrations for divestments/ acquisitions and support monitoring quality & timeliness and complete documentation audit trail of DM. Participates in business continuity arrangements and assists with the authoring and implementation of PV Operations business continuity plan (BCP) processes. Collaborates with CHC PV ops leads, CSH and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities. Participate in the development and continuous improvement of processes, workflow, and supporting documents. Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc. Experience in case processing activities. Experience in team management Experience in overseeing vendors responsible for case processing. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office 6-8 years of pharmaceutical industry experience with a focus on pharmacovigilance with min 2 years in managing team Strong experience in ICSR quality review and submissions Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Time Management: Ability to manage multiple projects and deadlines effectively, ensuring that safety reports and data analysis are delivered on time. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Technical Skills Understanding of Adverse Event Reporting: Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders. Education Bachelor’s degree in pharmacy / Life Sciences / equivalent Academic qualification is desirable with 6-8 years of experience and min. 6 years in Global PV case processing activities Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less

Key Responsibilities: Scientific Leadership & Stakeholder Engagement: Develop and maintain a deep understanding of the latest scientific and medical knowledge in the therapeutic area. Build and sustain professional relationships with Therapeutic Area Experts (TAEs) through impactful scientific discussions. Continuously update and map key TAEs to ensure strategic alignment. Medical Insights & Strategic Planning: Gather clinical insights from TAEs to shape Medical Action Plans, TAE Interaction Plans, and overall medical strategy. Work cross-functionally to integrate medical insights into broader business strategies. Internal Collaboration & Training: Serve as a key field-based resource for scientific and clinical expertise. Support scientific training initiatives for commercial teams to enhance their knowledge. Medical Information & Compliance: Provide evidence-based, scientifically balanced responses to unsolicited medical inquiries from HCPs. Ensure strict adherence to compliance regulations regarding medical information exchange. Clinical Research & Development Support: Assist in company-sponsored and investigator-initiated studies within the therapeutic area. Contribute to clinical research programs, national disease registries, and real-world evidence (RWE) projects. Patient Awareness & Advocacy: Support patient awareness initiatives through both physical and digital platforms. Collaborate with TAEs to enhance patient journey understanding and improve outcomes. Preferred Qualifications & Experience: Therapeutic Focus: Candidates with experience in Diabetes, Cardiology, or Cardio-Metabolic therapy preferred. Experience: 1-2 years in medical affairs, preferably as an MSL, RMA, or Medical Executive. This is an excellent opportunity to play a strategic role in medical affairs with a global pharmaceutical leader.

We are seeking a Regional Medical Advisor for a Global Pharmaceutical MNC to provide scientific expertise, medical insights, and strategic support for cardiology therapies. This role involves KOL engagement, medical affairs strategy, and market access initiatives while ensuring alignment with business objectives and healthcare policies. Key Responsibilities: 1. Scientific & Medical Expertise ? Acquire and update scientific knowledge on cardiology therapies and relevant compounds. ? Provide timely, accurate, and balanced medical information to internal and external stakeholders. ? Support the development of institutional medical plans in alignment with brand strategy. ? Assist in clinical studies, real-world data generation, and global clinical trials , including site identification and patient recruitment. 2. Key External Expert (KEE) & Stakeholder Engagement ? Identify and segment Key External Experts (KEEs) based on scientific interest and affiliations. ? Develop engagement plans with medical associations, societies, and patient support groups. ? Conduct 75% field engagement with priority healthcare professionals and key stakeholders. ? Provide medical training and scientific insights to institutional teams. 3. Government & Institutional Collaboration ? Develop and implement state-specific medical plans for government institutions. ? Represent the company at state health departments and bureaucratic bodies . ? Support policy shaping, evidence generation, and market access activities . ? Co-create value dossiers for approved indications and support their inclusion in clinical practice protocols. 4. Innovation & Market Expansion ? Partner with Innovation teams to identify and execute initiatives for disease management gaps. ? Engage in pre-launch medical activities for new products. ? Prepare and deliver scientific presentations at congresses, symposia, and medical meetings. ? Contribute to scientific literature development , including research publications and medical articles. Why You Basic Qualifications: ? BDS, MBBS, or MD qualification. ? Minimum 6 months experience in Medico-Marketing & KOL Management . ? Strong knowledge of clinical practices, cardiology therapies, and healthcare policies . ? Excellent communication and stakeholder management skills. ? Willingness to travel 30% of the time for field engagements.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: MBBS/MD

Job Overview The Director of Product Engineering will lead the strategy and development of our Patient Safety software. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. Summary Of Responsibilities Lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. Define and prioritize product requirements, features, and functionalities in collaboration with engineering, sales, and customer support teams. Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders. Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success. Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement. Ensure compliance with industry regulations and standards. Manages product like a business owner, owning portfolio forecasts, budget management, and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend. Manage support teams responsible for the Patient Safety incident and problem management processes. Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs. Qualifications (Minimum Required) Bachelor’s degree in computer engineering Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Proficiency in product management tools and methodologies (including DevOps) Exceptional analytical, strategic thinking, and problem-solving skills. Excellent communication and interpersonal skills, capable of working effectively with cross functional teams. Experience (Minimum Required) At least 6+ years of experience in product management within the life sciences or software development industry in Pharmacovigilance. Experience in developing and launching software products Proven track record of managing all aspects of a successful product throughout its lifecycle. Experience with Agile Methodologies. Experience with managing globally diverse matrixed teams. Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.). Knowledge of Gxp and highly regulated environments. Drive innovation and continuous improvement in patient safety solutions with knowledge of industry technology and product trends in the Patient Safety space Focusing on user centered design principles for an intuitive product Understanding of data Preferred Qualifications/Experience Include Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. Prior experience in a startup or a fast-paced environment. Certification in Product Management or Agile methodologies. Strong understanding of Patient Safety processes within the CRO industry. Strong technical background with understanding of software development processes. Demonstrated ability to think creatively and strategically when solving problems and making decisions. Learn more about our EEO & Accommodations request here. Show more Show less

Summary Of Responsibilities Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up. Perform and support different activities as assigned – tracking several types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Create and revise training materials based on procedural, system, and regulation updates. Responsible in conducting trainings and checks the effectiveness of the trainings as required. Assume responsibility for quality of data processed. Any other duties as assigned by management. And all other duties as needed or assigned. Qualifications (Minimum Required) Bachelor’s or Masters in Pharmacy or Life Science or Medical Science or related area + 2 to 3 years of safety experience. BS/BA + 2 to 3 years of safety experience. MA/MS/PharmD + 1 to 2 years of safety experience. Associate degree + 4-5 years relevant experience** (or 2+ years safety experience) * Non degree + 5-6 years relevant experience** (or 2+ years safety experience) * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. Fluent in English, both written and verbal. Experience (Minimum Required) Experience in call center operations is preferred Preferred Qualifications Include Degree preferred (but not necessarily) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. Good written and verbal communication skills. Ability to receive and manage in-bound and out-bound calls. Ability to analyze and synthesize medical information. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines. Technical proficiency with Microsoft Office suite applications. High degree of accuracy with attention to detail. Functions as a team player. Ability to work independently with moderate supervision. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview The Director of Product Engineering will lead the strategy and development of our Patient Safety software. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. Summary Of Responsibilities Lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. Define and prioritize product requirements, features, and functionalities in collaboration with engineering, sales, and customer support teams. Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders. Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success. Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement. Ensure compliance with industry regulations and standards. Manages product like a business owner, owning portfolio forecasts, budget management, and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend. Manage support teams responsible for the Patient Safety incident and problem management processes. Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs. Qualifications (Minimum Required) Bachelor’s degree in computer engineering Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Proficiency in product management tools and methodologies (including DevOps) Exceptional analytical, strategic thinking, and problem-solving skills. Excellent communication and interpersonal skills, capable of working effectively with cross functional teams. Experience (Minimum Required) At least 6+ years of experience in product management within the life sciences or software development industry in Pharmacovigilance. Experience in developing and launching software products Proven track record of managing all aspects of a successful product throughout its lifecycle. Experience with Agile Methodologies. Experience with managing globally diverse matrixed teams. Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.). Knowledge of Gxp and highly regulated environments. Drive innovation and continuous improvement in patient safety solutions with knowledge of industry technology and product trends in the Patient Safety space Focusing on user centered design principles for an intuitive product Understanding of data Preferred Qualifications/Experience Include Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. Prior experience in a startup or a fast-paced environment. Certification in Product Management or Agile methodologies. Strong understanding of Patient Safety processes within the CRO industry. Strong technical background with understanding of software development processes. Demonstrated ability to think creatively and strategically when solving problems and making decisions. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years’ experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment Office Environment . Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years’ experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment Office Environment . Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective communication with country-specific pharmacovigilance contacts to support global reporting obligations. Support internal and external audits by providing accurate and timely safety documentation and regulatory compliance records. Interested Candidates please send me resumes to sravana.a@hetero.com

Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelors degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts.

- Serve as the Lead Programmer and Manager of the statistical programming efforts. - Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. - Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. - Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. - Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. - Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. - Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. - Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. - Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. - Act as the primary department contact to ensure that department standards are implemented in all studies. - Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. - Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience - 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. - 4+ years project management experience in the CRO or Pharmaceutical Industry. - Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. - Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. - Strong verbal and written communication skills - ability to clearly and effectively present information. - An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. - Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. - Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. - Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. - Advanced experience with: - Constructing technical programming specifications. - Relational Databases. - Good Clinical Practices. - Good Programming Practices. - 21CFR Part 11 Standards. - Integrated Summary Safety/Efficacy Analyses. - Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience - BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. - Competencies: - Accountability - Collaboration - Decision Quality - Drive for Results - Perseverance - Problem Solving - Informing - Peer Relationships - Time Management - Building Effective Teams - Managing Through Systems

Essential Skills/Experience: Medical degree (eg MD, MBBS) At least 2 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals Minimum 3 years of Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery) Desirable Skills/Experience: Able to work across TAs and Functions Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data Skills and Capabilities: Commitment to Customers and Integrity Strategic Leadership Acts Decisively Drives Accountability Works Collaboratively Develops People and Organisation May train or mentor junior level staff within given role Technical: Drug Development Experience and Application of Disease and TA knowledge Integrative thinking Excellence in pharmacovigilance Patient Benefit risk assessment Core: Conceptual thinking Influencing Initiative Innovation Business relationship management

Essential Skills/Experience: Medical degree (eg MD, MBBS) At least 2 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals Minimum 3 years of Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery) Total of 6 to 11 years of experience Desirable Skills/Experience: Able to work across TAs and Functions Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data Skills and Capabilities: Commitment to Customers and Integrity Strategic Leadership Acts Decisively Drives Accountability Works Collaboratively Develops People and Organisation May train or mentor junior level staff within given role Technical: Drug Development Experience and Application of Disease and TA knowledge Integrative thinking Excellence in pharmacovigilance Patient Benefit risk assessment Core: Conceptual thinking Influencing Initiative Innovation Business relationship management

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Clinical Operations Manager POSITION PURPOSE The COM 2 is a regional role that provides expertise across all aspects of clinical site management and/ or study management for assigned Phase I – IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer’s standard operating procedures. The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities. A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer’s standard operating procedures, including any requirements for independent review and oversight. ROLE AND RESPONSIBILITIES STUDY MANAGEMENT Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out. Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct. Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File. Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up. CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement. Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities. Cross functional collaboration to ensure alignment of priorities and deliver the portfolio. Influence and challenge internal and external factors to improve clinical research delivery. STUDY START-UP Lead study start-up activities in collaboration with local team. Provide input on site activation strategy. Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. Compile and submit submission dossier (country dependent). Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures). Prepare and distribute site start up documentation including Investigator Site File. Ensure timely filing of study documents at country and site level in Trial Master File (TMF). Ensure awareness of related local regulations and support maintenance of country intelligence. Provide study status monitoring and systems support (e.g. act as technical expert) Coordinate site and vendor payments. QUALITY Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data. Maintain corrective action and preventative action plans (CAPAs) at country level. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome. Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs. OTHER Participate in expert working groups, project standard teams, and similar initatives. Contribute to global process improvement efforts. Share knowledge and experience with a coaching mindset Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel. KEY WORKING RELATIONS: Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal and other functions. Globally with study team members, QA & Inspection management. External: With site personnel, third party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders and/or other committees. WHO YOU ARE: Healthcare related Bachelor’s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Other qualifications: Fundamental project management skills Awareness & understanding of cultural and regional differences Communication, oral presentation & interpersonal skills Decision making Issue resolution Planning and organization, time management, prioritization Thrives in ambiguous and collaborative environments and embraces change Effective written and verbal English communication skills Willingness to travel to sites, study meetings, local and international level 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/en/strategy/strategy 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”. 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 : Karnataka : Bangalore || India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 848115 Contact Us + 022-25311234

Training Programme Development Design, develop, and implement training programmes tailored to GBS and client goals and employee needs Create engaging training materials, specifically for GBS induction, including manuals, e-learning modules, and workshops Continuously evaluate the GBS training effectiveness and make improvements based on feedback Employee Development & Skills Enhancement Identify skills gaps and develop strategies to enhance employee competencies Work with Regional and local MC L&D resource to ensure GBS employees maintain relevant competencies to support our client s needs Organise onboarding programmes for new hires to ensure a smooth transition into the company Training Delivery & Coordination Coordinate GBS employees relevant, and ongoing training content and sessions in collaboration with client L&D trainers Conduct training sessions in-person, online or through a blended learning approach Work with subject matter experts to ensure accuracy and relevance of existing and future training content Performance Evaluation & Compliance Assess training impact through feedback, assessments, and key performance indicators (KPIs) Ensure all training programmes follow industry regulations and company policies Keep up to date with standard methodologies in corporate training and learning technologies Ensure all GBS Patient Safety colleagues complete all mandatory training on time and to required standard Sustainability and Training Quality Assurance Audit and review training materials for accuracy, relevance, and compliance with industry and the client s standards Maintain training content integrity and ensure long-term learning effectiveness Maintain accurate records of training and training completion for quality management and audit purposes Lead the GBS Patient Safety Training Centre of Excellence (CoE) through sharing best practice and proactively promoting learning and development opportunities Support the GBS Leadership Team in projects and initiatives to help the Business achieve goals and objectives Essential Skills/Experience Bachelors degree in human resources, Business Administration, education or a related field 3+ years of experience in training, learning and development, or human resources Strong presentation skills and effective delivery of L&D practices Cross functional collaborative approach Effective and analytical thinking with the ability to measure and assess the effectiveness of training initiatives Problem solving Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience Experience in corporate training, instructional design, or leadership development Experience in Pharmacovigilance, Patient Safety or similar industry Influencing, and Conflict Resolution skills. Successful participation in above-market projects Familiarity with Learning Management Systems and e-learning tools

Your key responsibilities will include leading and managing a local case intake team, overseeing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs), and ensuring timely and accurate processing of patient safety cases. Youll monitor local case intake metrics, prepare reports on key performance indicators, and identify areas for improvement. Staying updated on pharmacovigilance regulations, participating in audits, conducting quality checks, and serving as a liaison between local and global levels are also part of your role. Additionally, youll participate in ad-hoc projects related to case handling. Essential Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Degree Qualified - Pharmacy/ Medical/ Science Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry Thorough knowledge of the current pharmacovigilance and regulatory developments Experience in working cross-functionally Ability to set and manage priorities, resource goals and project initiatives Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less