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Associate Director Clinical Safety
System One • Remote • Posted 15 days ago
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Remote • Full-time • $100.00/hr • Contract • Mid Level Manager
Job Highlights
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The Associate Director, Clinical Safety at System One will support safety monitoring and risk management activities for products in development, working closely with a senior physician and other cross-functional teams. This role involves signal identification and evaluation, risk mitigation and communication, responding to Health Authority inquiries, and providing integrated safety input into regulatory documents. The position requires 1-3 years of Pharmacovigilance/clinical safety experience and is open to international MDs. This is a 12-month contract position offering up to $100/hr based on experience.
Responsibilities
- Carries out routine signal identification and evaluation activities for assigned products in development phase
- 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
- Presents 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 required during active development, and submission phase
- Defines the risk component of the B/R assessment
Qualifications
Required
- MD/DO Degree Required (international MD degree is acceptable)
- 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs
- Demonstrated ability to implement strategy and processes and collaborate with others
Preferred
- Safety experience in clinical development
- Experience in rare disease
Full Job Description
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:
+ 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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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