Associate Director Clinical Safety
Basking Ridge, New Jersey
Employer: System One Holdings, LLC
Industry:
Salary: $100 per hour
Job type: Full-Time
Associate Director, Clinical Safety MD
Pharma In New Jersey - Remote (no west coast, only EST or CST)
12 month contract | Up to $100/hr dependent on experience.
Notes from Hiring manager:
Education: Education: MD/DO Degree Required (international MD degree is acceptable)
Client's JD:
Position supports safety monitoring and risk management activities for products in development. This position will work closely with a senior physician. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members.
Responsibilities
Skills:
Needed for submittal: - highest education & graduation MONTH & YEAR, - birth month & date, - last 4 digits of SS, - email & phone number
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Pharma In New Jersey - Remote (no west coast, only EST or CST)
12 month contract | Up to $100/hr dependent on experience.
Notes from Hiring manager:
- Rare disease is a plus
- international MD is okay
- 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work.
- Demonstrated ability to implement strategy and processes and collaborate with others
- Safety experience in clinical development preferred
Education: Education: MD/DO Degree Required (international MD degree is acceptable)
Client's JD:
Position supports safety monitoring and risk management activities for products in development. This position will work closely with a senior physician. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members.
Responsibilities
- Signal Identification and evaluation: Carries out routine signal identification and evaluation activities for assigned products in development phase
- Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.
- Responsible for responses to Health Authority inquiries on safety issues and prepares safety data for safety review boards.
- Present safety data in SMTs as a product safety expert
- Prepares, summarizes, and reviews aggregate safety analyses.
- Performs safety assessments and determines the safety profiles of assigned products.
- Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, CSR, Clinical Overview and Integrate safety summary) required during active development, and submission phase.
- Defines the risk component of the B/R assessment.
Skills:
- 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work.
- Demonstrated ability to implement strategy and processes and collaborate with others.
- Safety experience in clinical development preferred.
- Experience in rare disease is a plus.
Needed for submittal: - highest education & graduation MONTH & YEAR, - birth month & date, - last 4 digits of SS, - email & phone number
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Created: 2024-09-06
Reference: 325230
Country: United States
State: New Jersey
City: Basking Ridge
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