Placements24

About the Role

Our client, a globally recognized pharmaceutical company dedicated to improving patient outcomes through innovative therapies, is seeking a highly motivated and experienced Remote Senior Pharmacovigilance Scientist. This critical, fully remote position will be integral to monitoring the safety profile of our client's diverse product portfolio. The successful candidate will play a key role in the collection, assessment, and reporting of adverse event data, ensuring compliance with global regulatory requirements and maintaining the highest standards of patient safety. This is an exceptional opportunity to leverage your expertise in a remote-first environment, contributing to significant global health initiatives without the need for a fixed office location.

You will work collaboratively with cross-functional teams to safeguard public health and uphold the integrity of our client's drug safety processes. The role requires a proactive, detail-oriented individual with a strong scientific background and excellent analytical skills. We are looking for a self-disciplined professional who thrives in an independent work setting and is passionate about drug safety and risk management.

Key Responsibilities

• Perform detailed assessment of adverse event reports, including causality assessment and seriousness determination.
• Contribute to the preparation and submission of regulatory safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Developmental Safety Update Reports (DSURs).
• Participate in signal detection and risk assessment activities, identifying potential safety trends and concerns.
• Collaborate with regulatory affairs, clinical development, and medical affairs teams on safety-related matters.
• Contribute to the development and maintenance of safety databases and associated documentation.
• Provide input into the design of clinical trial protocols and investigator brochures from a safety perspective.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Support regulatory agency inspections and audits related to pharmacovigilance activities.
• Respond to safety inquiries from regulatory authorities and other stakeholders.
• Assist in the development and implementation of risk management plans (RMPs).

Requirements

• Advanced degree (M.S., Ph.D., Pharm.D., M.D.) in a life science, pharmacy, or related healthcare field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety, preferably within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines).
• Experience with safety databases (e.g., Argus, ARISg) and adverse event reporting systems.
• Strong scientific understanding and ability to critically evaluate clinical and safety data.
• Excellent written and verbal communication skills, with the ability to articulate complex scientific information clearly.
• Proven ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office Suite.
• Experience with signal detection methodologies is a plus.

Benefits

• competitive salary
• including health, dental, and vision insurance
• a retirement savings plan with company match
• generous paid time off