2 Senior Pharmacovigilance Scientist Drug Safety jobs in whatjobs
Senior Pharmacovigilance Scientist, Drug Safety
Posted 20 days ago
Job Viewed
Job Description
Our client is actively seeking a highly experienced Senior Pharmacovigilance Scientist to join their fully remote drug safety team. In this crucial role, you will be responsible for the comprehensive safety surveillance of assigned pharmaceutical products throughout their lifecycle. Your primary duties will include performing signal detection and assessment, managing regulatory submissions related to safety information, and contributing to the development of risk management plans. You will conduct in-depth analysis of adverse event data, identify potential safety trends, and provide expert recommendations to cross-functional teams, including regulatory affairs, clinical development, and medical affairs. A significant part of your role will involve authoring and reviewing periodic safety update reports (PSURs), development safety update reports (DSURs), and other safety-related regulatory documents. You will also play a key role in the preparation for and response to regulatory authority inspections. The ideal candidate possesses a strong understanding of global pharmacovigilance regulations (e.g., FDA, EMA), signal detection methodologies, and benefit-risk assessment principles. Experience with safety databases and case processing systems is essential. You will collaborate with internal and external stakeholders, including healthcare professionals and investigators, to ensure the accurate and timely collection and reporting of safety data. This is an exceptional opportunity to contribute to patient safety and drug development from the convenience of your remote workspace, impacting the safe use of medicines worldwide. We are committed to fostering a robust and compliant drug safety program and require a dedicated professional to uphold these standards. Your analytical skills and meticulous attention to detail will be paramount in this role. We provide a supportive remote work environment with the necessary tools and resources to facilitate your success in safeguarding public health.
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Senior Pharmacovigilance Scientist - Drug Safety
Posted 10 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking a highly qualified Senior Pharmacovigilance Scientist to enhance their drug safety surveillance and risk management activities. This critical role involves the comprehensive assessment of adverse event data, development of safety profiles for investigational and marketed products, and contribution to regulatory submissions. You will work closely with clinical development, regulatory affairs, and medical teams to ensure patient safety and compliance. This position is fully remote, offering a flexible work arrangement.
Responsibilities:
Responsibilities:
- Monitor and assess safety data for assigned investigational and marketed pharmaceutical products.
- Perform signal detection and evaluation, identifying potential new safety concerns.
- Author and contribute to the development of safety documents, including Investigator's Brochures (IBs), Clinical Study Reports (CSRs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs).
- Collaborate with clinical operations and medical monitors to ensure timely reporting and appropriate management of adverse events.
- Liaise with regulatory authorities on safety matters and respond to regulatory inquiries.
- Participate in cross-functional safety team meetings and contribute to safety decision-making.
- Develop and implement pharmacovigilance processes and standard operating procedures (SOPs).
- Train and mentor junior pharmacovigilance staff.
- Stay updated on global regulatory requirements and guidelines related to drug safety and pharmacovigilance.
- Contribute to the design of clinical trial safety protocols.
- Review and provide input on safety sections of regulatory submission documents (e.g., INDs, NDAs).
- Manage vendor activities related to pharmacovigilance, as applicable.
- Ensure compliance with Good Pharmacovigilance Practices (GVP) and other relevant regulations.
- Advanced degree (Pharm.D., M.D., Ph.D., M.S.) in a life science, medical, or related field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.
- Thorough understanding of pharmacovigilance principles, methodologies, and global regulatory requirements (e.g., FDA, EMA).
- Experience in signal detection and evaluation, risk assessment, and benefit-risk evaluation.
- Proficiency in authoring key safety documents (IBs, RMPs, PSURs).
- Knowledge of clinical trial processes and medical terminology.
- Strong analytical, critical thinking, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.
- Experience with safety databases (e.g., Argus, Aris) is desirable.
- Familiarity with ICH guidelines and other relevant regulatory standards.
This advertiser has chosen not to accept applicants from your region.
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