Clinical Safety Specialist

Brief team/department description:

The Drug Safety team within Medical Affairs plays a critical role in ensuring the safety and well-being of patients by monitoring, evaluating, and reporting adverse events across all stages of a product s lifecycle. This team collaborates closely with cross-functional partners, including Regulatory Affairs, Clinical Development, and Quality, to ensure compliance with global pharmacovigilance regulations and maintain the highest standards of patient safety.

The Clinical Safety Specialist is an integral member of the team. The Drug Safety Clinical Specialist will be responsible for evaluating and managing clinical safety data to ensure the safety and well-being of patients throughout the drug development and post-marketing processes. This position will focus on analyzing adverse events (AEs) and ensuring compliance with regulatory requirements. The role involves collaborating with cross-functional teams to assess the risk-benefit profile of products and contribute to pharmacovigilance activities. This position requires a detailed understanding of clinical trial processes, drug safety regulations, and clinical data management.

Principle Responsibilities:

• Review and assess adverse event (AE) reports from clinical trials, post-market surveillance, and spontaneous/literature reports.
• Ensure timely and accurate reporting of serious adverse events (SAEs) to regulatory authorities, including the FDA, EMA, and other relevant bodies.
• Assist in preparation and review of clinical safety documents, including Safety Management Plans (SMPs), Clinical Safety Reports (CSR) clinical protocols, and other required regulatory clinical safety reports.
• Ensure compliance with national and international pharmacovigilance regulations, including GxP, ICH guidelines, FDA, EMA, and local regulatory bodies.
• Participate in audits and inspections by regulatory authorities or internal audit teams related to drug safety and pharmacovigilance activities.
• Collaborate with clinical research teams to assess clinical trial safety data, identify adverse events of special interest (AESIs), and ensure timely reporting to regulatory authorities.
• Support the preparation of safety-related sections in clinical trial protocols and support business development clinical safety reviews.
• Assist in the design and execution of safety surveillance strategies for clinical trials, including interim safety analyses and risk assessments to ensure that there are no gaps between clinical and safety teams.

Qualifications and Educational Requirements

• Bachelor s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field. Advanced degrees (MS, PhD, PharmD) are a plus
• 3+ years of experience in pharmacovigilance, drug safety, clinical research, or a related field.
• Knowledge of clinical trial processes, regulatory guidelines, and pharmacovigilance practices.
• Experience in adverse event reporting, case processing, and regulatory submissions including 505B2.
• Strong analytical skills with the ability to review, analyze, and interpret clinical safety data.
• Proficiency in pharmacovigilance software systems (e.g., Argus, MedDRA, etc).
• Excellent written and verbal communication skills, with the ability to interact with regulatory authorities, clinical teams, and external stakeholders.
• Ability to work collaboratively in cross-functional teams and communicate effectively with diverse stakeholders.