Safety Scientist/Senior Safety Scientist

7+ years

Not Disclosed

Massachusetts

10 Feb. 15, 2025

Job Description

Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety Scientist/Senior Safety Scientist
Company: Viridian Therapeutics, Inc.
Location: Waltham, MA, USA (Remote)
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision

Description:
Viridian Therapeutics is dedicated to developing best-in-class medicines for individuals living with autoimmune and rare diseases. Utilizing expertise in antibody discovery and engineering, the company has built a strong pipeline of differentiated investigational therapeutics. Viridian values data-driven decisions, thoughtful risk-taking, and efficient resource use while fostering a culture of open communication, transparency, and career growth.

Reporting to the Vice President of Pharmacovigilance, the Safety Scientist/Senior Safety Scientist will be responsible for ensuring the safety of clinical trial participants and maintaining the integrity of clinical trial data. This role involves monitoring, analyzing, and assessing adverse events, collaborating with cross-functional teams, and supporting safety surveillance and documentation efforts.

This position may be based in Waltham, MA, in a hybrid role requiring three days per week in the office or fully remote with occasional travel to headquarters.

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 timely collection, analysis, and reporting of adverse events per regulatory requirements. Track and monitor all SAEs and SUSARs.
Risk Management: Develop and implement risk management plans to mitigate potential safety risks.
Regulatory Compliance: Ensure adherence to FDA, EMA, and ICH guidelines.
Safety Documentation: Prepare and review safety-related documents, including Safety Management Plans, Study Protocols, Informed Consent Forms, Investigator Brochures, DSUR/PSUR, CTD Module 2.5 & 2.7.4, Risk Management Plans, and Company Core Data Sheets.
Cross-Functional Collaboration: Work with clinical operations, clinical development, regulatory affairs, and PV vendors to ensure patient safety.
Safety Signal Detection: Utilize statistical methods and data analysis tools to detect and evaluate safety signals.
Literature Surveillance: Oversee the PV vendor's literature surveillance plan and operations.
Training and Education: Provide training on safety reporting and regulatory requirements.
Other Duties: Perform additional responsibilities as assigned.

Qualifications:

Bachelor's degree in a scientific discipline (e.g., biology, pharmacy, nursing); advanced degree preferred.
Senior Safety Scientist: 7+ years of clinical safety or pharmacovigilance experience with an advanced degree, 10+ years without.
Safety Scientist: 5+ years of clinical safety or pharmacovigilance experience with an advanced degree, 7+ years without.
Strong knowledge of clinical trial processes, regulatory requirements, and safety reporting guidelines.
Familiarity with EU GVP, FDA, and ICH guidelines, including Good Clinical Practices (GCP).
Experience with MedDRA, WHO Drug Dictionary terminology, and common safety database systems (Argus/ArisG/Veeva Safety).
Ability to develop and review SOPs and Work Instructions.
Strong organizational skills and adaptability in a fast-paced environment.
Excellent verbal and written communication skills for internal and external collaboration.
Attention to detail and high accuracy.
Ability to work independently and within a team.
Strong problem-solving and decision-making skills.

Compensation:
Salary is commensurate with experience.

Benefits:

Competitive pay and stock options for all employees.
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and eligible dependents.
Fertility and mental health programs.
Short- and long-term disability coverage.
Life, Travel, and AD&D insurance.
401(k) Company Match with immediate vesting.
Employee Stock Purchase Plan.
Generous vacation plan and paid company holiday shutdowns.
Various mental, financial, and proactive physical health programs.

Equal Employment Opportunity:
Viridian Therapeutics, Inc. is an equal opportunity employer and prohibits discrimination, harassment, or retaliation based on legally protected characteristics. The company provides reasonable accommodations for individuals with disabilities during the job application or interview process and throughout employment.

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Safety Scientist/Senior Safety Scientist

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