Managing the pharmacovigilance team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards.
Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices.
Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans.
Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials.
Staying updated on industry regulations and best practices in pharmacovigilance to drive continuous improvement initiatives.
Qualifications
Degree in life sciences, pharmacy, or a related field; advanced degree or relevant certifications are preferred.
Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries.
Strong understanding of regulatory requirements related to drug safety and reporting.
Excellent analytical and problem-solving skills, with a focus on data-driven decision-making.
Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders.