SPE-Pharmacovigilance

Job SummaryJoin our team as a Voice Specialist in Pharmacovigilance where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on the clinical process you will contribute to the monitoring and evaluation of drug safety data. This hybrid role offers the opportunity to work both remotely and on-site providing flexibility and a dynamic work environment.ResponsibilitiesMonitor and evaluate drug safety data to ensure compliance with regulatory standards and guidelines.Collaborate with cross-functional teams to assess and report adverse drug reactions and safety concerns.Utilize your expertise in the pharma clinical process to enhance the accuracy and efficiency of pharmacovigilance activities.Conduct thorough case processing and documentation to support regulatory submissions and safety assessments.Analyze safety data to identify trends and potential risks contributing to the development of risk management strategies.Provide insights and recommendations to improve pharmacovigilance processes and ensure patient safety.Support the development and implementation of pharmacovigilance systems and tools to streamline operations.Engage in continuous learning and development to stay updated on industry trends and regulatory changes.Work closely with research and development teams to integrate safety data into product development plans.Ensure timely and accurate reporting of safety information to regulatory authorities and stakeholders.Participate in audits and inspections to demonstrate compliance with pharmacovigilance regulations.Contribute to the preparation of safety reports and risk assessment documents for internal and external use.Foster a culture of safety and compliance within the organization promoting best practices in pharmacovigilance.QualificationsPossess a strong background in pharma clinical processes with a minimum of 3 years of experience.Demonstrate expertise in PV case processing and familiarity with research and development activities.Exhibit excellent analytical and problem-solving skills to assess and interpret safety data.Show proficiency in using pharmacovigilance databases and tools for data management and reporting.Display effective communication skills to collaborate with cross-functional teams and stakeholders.Maintain a high level of attention to detail and accuracy in documentation and reporting.Have a proactive approach to identifying and addressing potential safety issues.Certifications RequiredCertified Pharmacovigilance Professional (CPP) or equivalent certification in drug safety.