For one of our key clients in the pharmaceutical industry, we are looking for two experienced professionals to join the Corporate Patient Safety function and support strategic pharmacovigilance activities across clinical development and marketed products.
Key Responsibilities
- Define and execute safety strategies for investigational medicinal products.
- Perform medical assessment of SUSARs, safety signals, and benefit-risk evaluations.
- Support clinical development activities, including protocol reviews, Investigator's Brochures, and safety monitoring plans.
- Manage clinical trial safety activities including SAE management, reconciliation, and unblinding processes.
- Lead and contribute to DSURs, Risk Management Plans (RMPs), PASS activities, and other regulatory safety reports.
- Participate in safety governance committees, project teams, and safety monitoring meetings.
- Support regulatory submissions and provide safety input to development programs.
- Act as a key safety contact for internal stakeholders, CROs, and partners.
- Medical Degree (MD).
- Minimum 3 years of experience in Clinical Development, Pharmacovigilance, or Drug Safety.
- Strong experience in safety monitoring, signal detection, and benefit-risk assessment.
- Experience with clinical trial safety activities and regulatory safety reporting.
- Knowledge of Risk Management Plans (RMPs), DSURs, and PASS studies.
- Experience working with safety databases, MedDRA, and EudraVigilance.
- Fluent English and Spanish.
- Experience supporting regulatory submissions and health authority interactions.
- Previous experience acting as safety lead for investigational products.
- Experience collaborating with CROs and external partners.
- Knowledge of Pharmacovigilance Quality Management Systems.
Start Date: ASAP
Location: 100% Remote
Duration: 1 Year
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