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Company

Viridian Therapeutics, Inc. · 6 hours ago

Sr/Safety Scientist, Drug Safety & Pharmacovigilance

United States

Full-time

Remote

Senior Level

7+ years exp

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BiotechnologyGenetics

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Responsibilities

Safety Data Monitoring: Continuously monitor safety data from clinical trials to identify potential safety signals

Safety Management Team: Organize meetings, summarize and analyze safety data and prepare meeting minutes

Adverse Event Reporting: Ensure the timely collection, analysis, and reporting of adverse events in accordance with regulatory requirements and company policies. Track and monitor all SAEs and SUSARs

Risk Management: Develop and implement risk management plans to mitigate potential safety risks

Regulatory Compliance: Ensure compliance with all relevant regulatory guidelines, including FDA, EMA, and ICH guidelines

Safety Documentation: Prepare and review safety-related documents, including Safety Management Plan, Study Protocols and Amendments, Informed Consent Forms, Investigator Brochure, DSUR/PSUR, CTD Module 2.5 & 2.7.4, Risk Management Plan and Company Core Data Sheet

Cross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participants

Safety Signal Detection: Oversee the use of statistical methods and data analysis tools to detect and evaluate safety signals

Literature Surveillance: Oversee the PV vendor literature surveillance plan and operations

Training and Education: Provide training and support to clinical trial staff on safety reporting and regulatory requirements

Perform other duties as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical safetyPharmacovigilanceRegulatory complianceSafety signal detectionRisk managementSafety documentationStatistical methodsMedDRA terminologyCommon safety databases

Required

Requires a Bachelor's degree in a scientific discipline (e.g., biology, pharmacy, nursing)

5+ years (7+ years for Sr. Safety Scientist) of clinical safety or pharmacovigilance

Strong understanding of clinical trial processes, regulatory requirements, and safety reporting guidelines

Thorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelines

Knowledge of MedDRA and WHO Drug Dictionary terminology and its application

Development and review of SOPs and Work Instructions

Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities

Excellent verbal and written communication skills including the ability to present to both internal and external partners

Attention to detail and high level of accuracy

Ability to work both independently and as part of a team

Strong problem-solving skills and sound decision-making under pressure

Preferred

Advanced degree (e.g., Master's, PhD) preferred

Experience with common safety database systems (Argus/ArisG/Veeva Safety)

Benefits

Competitive pay and stock options for all employees

Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents

Fertility and mental health programs

Short- and long-term disability coverage

Life, Travel and AD&D

401(k) Company Match with immediate company vest

Employee Stock Purchase plan

Generous vacation plan and paid company holiday shutdowns

Various mental, financial, and proactive physical health programs covered by Viridian

Company

Viridian Therapeutics, Inc.

Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases.

Founded in 2007

Waltham, Massachusetts, USA

51-200 employees