PV Coordinator

(Target PR: 35-40/hr)

• Ensure timely and accurate processing of adverse event reports in accordance with company policies and regulatory requirements
• Conduct thorough investigations and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams
• Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders
• Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions
• Develop and maintain strong relationships with external partners, such as regulatory agencies and contract research organizations
• Assist with the development and implementation of pharmacovigilance processes and procedures
• Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance
• Participate in cross-functional meetings and contribute to the development of risk management plans for products
• Support the preparation and submission of regulatory reports and responses to safety-related inquiries
• Collaborate with other departments, such as Clinical Development and Medical Affairs, to ensure the safety of products throughout their lifecycle
• Maintain accurate and up-to-date documentation of all pharmacovigilance activities
• Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
• Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work
• Participates in project teams, and where required provides training and support to team members in respect of safety reporting

• Education – bachelor’s degree or equivalent professional experience
• Previous experience of 2+ years of Pharmacovigilance / Drug Safety in a CRO or Pharma, Biotech environment.
• Preferably, experience of safety report distribution and submission, as well as healthcare administrative
• Training – Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines
• Exceptional attention to detail with a focus on accuracy and meticulous
• Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
• In-depth understanding of global and local pharmacovigilance (PV) regulations
• Understanding of medical terminology and familiarity with coding dictionaries g
• Experience with ArisG or a similar Safety Database a plus.
• Strong project management, interpersonal, verbal and written communication