PV Specialist

Luminary Group is seeking a skilled and detail-oriented PV Specialist to join our team. As a PV Specialist, you will play a critical role in ensuring the safety and compliance of pharmaceutical products. You will be responsible for monitoring and analyzing post-marketing adverse events, assessing product safety profiles, and creating comprehensive reports for regulatory authorities. This is an exciting opportunity to contribute to the safe use of medications and make a meaningful impact on public health.

Responsibilities:

• Monitor and evaluate incoming adverse event reports, ensuring timely and accurate data collection.
• Assess the seriousness and causality of adverse events, conducting detailed investigations and follow-up as required.
• Contribute to the preparation of periodic regulatory reports, including PSURs, PADERs, and DSURs.
• Collaborate with cross-functional teams including Medical Affairs, Regulatory Affairs, Quality Assurance, and Pharmacovigilance to ensure compliance with regulations and guidelines.
• Stay up-to-date with global regulatory requirements and guidelines related to pharmacovigilance, ensuring adherence to best practices.
• Participate in the review and implementation of pharmacovigilance processes and procedures, identifying opportunities for improvement and efficiency.
• Conduct signal detection activities, including data analysis and literature review, to identify potential safety concerns and facilitate risk management initiatives.
• Provide training and guidance to healthcare professionals and internal stakeholders on pharmacovigilance principles and processes.
• Support inspections and audits conducted by regulatory authorities or partners by providing accurate and timely information, documentation, and responses.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of [number] years of experience in pharmacovigilance or drug safety.
• Thorough understanding of relevant regulations and guidelines (e.g., ICH, EMA, FDA).
• Strong knowledge of pharmacovigilance databases and adverse event reporting systems.
• Excellent analytical and problem-solving skills, with the ability to assess and interpret complex data.
• Attention to detail and accuracy in data collection and analysis.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proactive mindset and ability to work independently with minimal supervision.
• Proficiency in pharmacovigilance software applications.
• Fluency in English, both written and spoken, is required.
• Knowledge of additional languages is a plus.