10 Pharmacovigilance Regulations Jobs

Purpose: The purpose of the Associate/Senior Associate/Associate Consultant, IT Systems Business Quality Assurance (BQA) u2013 Biometrics role is to support the development and implementation of quality systems strategy and activities to support the Data and Analytics and Global statistical science organizations goals and objectives for IT systems. In support of this mission, the purpose of the role of BQA-Biometrics is to act as a quality consultant and leader in integrating the quality requirements into the business processes.u00A0 The BQA-Biometrics will implement the quality plan and ensure consistency between the global requirements and local requirements.u00A0 This includes the impleme...

As a Pharmacovigilance professional at Clarivate, you will be responsible for performing pharmacovigilance services such as biomedical literature monitoring and assessing adverse events reporting. Your role will involve indexing and abstracting using your broad knowledge of scientific terms, medical terminology, drugs, and therapeutic areas, as well as pharmacovigilance regulations. **Key Responsibilities:** - Establish best practices and SOPs for literature screening activities, ensuring compliance with regulatory requirements and industry standards. - Oversee and coordinate all literature screening activities with a focus on quality and accuracy. - Ensure effective communication of finding...

Pharmacovigilance professionals perform pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. About You - Education, Experience, Skills Bachelor's degree or equivalent in Pharmacy, Life Sciences, Nursing, or related field Minimum 7 Years of Relevant Experience Experience with commercial and client-specific biomedical literature databases. Related experience in drug safety/ pharmacovigilance is required Writing skills to support the creation of succinct, accurate, and precise su...

The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. About You - Education, Experience, Skills Master's Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantage. At least 1-2 years of experience reviewing biomedical literature f...

As a Global PV Sr. Scientist at Amgen, you will play a crucial role in collaborating with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Your expertise will be essential in providing scientific and compliance support to Global Patient Safety (GPS) as required. Your key responsibilities will include: - Directing the planning, preparation, writing, and review of portions of aggregate reports - Coordinating liaison activities with affiliates and other internal partners at Amgen regarding products - Providing oversight to staff on safety in clinical trials, reviewing study protocols, statistical analysis plans, clinical study-related do...

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new sk...

Safety Analyst (Intern) **Good communication is must This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Plays an essential role supporting PV Operational Delivery to facilitate and meet client project...

Serves as a Subject Matter Expert (SME) within the PS Technical Solutions Team for reporting systems, ensuring they are capable of delivering high quality expertise and services across the PV systems estate, ensuring prioritized requirements and the strategic goals of stakeholders are understood and supported. Manages applicable tools, documentation and methodologies to ensure the reporting needs of organization are fully addressed and supported. Responsibilities of PV systems inclusive of relevant system processes, ensuring that the: System is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment, in-licensing,...

What you will do The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation proc...

Band : TBD Position Overview: Subject Matter Expert PCI Business We are seeking an experienced Subject Matter Expert (SME) in Pharmacovigilance Research to lead drug safety monitoring, regulatory compliance, and risk assessment initiatives. This role requires deep expertise in pharmacovigilance regulations, adverse event management, and clinical trial safety assessments. The SME will provide strategic guidance, ensure compliance with global regulatory standards, and support process optimization within pharmaceutical and biotech industries. Key Responsibilities Establish and maintain production and quality control protocols for data collection, analysis, and reporting processes Develop and im...