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About the role
- Vice President, Global Drug Safety at ADC Therapeutics overseeing drug safety operations and risk management activities for therapeutic products. Collaborating on safety strategies and ensuring regulatory compliance with a clinical focus.
Responsibilities
- Accountable for all of the activities and deliverables of the Drug Safety function
- Providing operational and medical oversight of safety activities for all ADCT’s medicinal products administered to humans
- Ensuring regulatory requirements are met
- Key driver of risk management strategies for all drugs in development and post approval
- Ensuring establishment and maintenance of core safety information during each product’s lifecycle
- Supervise and mentor the Drug Safety Department staff
- Effectively collaborate with other department heads within Development and team leaders
- Provide quality oversight to safety service providers
- Oversee safety data exchanges with license partners
- Reports to the Chief Medical Officer
Requirements
- MD required
- 7 years of clinical development experience including 4 years’ direct involvement in drug safety/pharmacovigilance activities
- In-depth knowledge of best drug safety/pharmacovigilance practices
- Expert knowledge in generation of periodic reports and in providing safety input on Clinical Study Protocols, IBs and Study Reports for products in development intended for regulatory approval, DSUR, PADER and PBRER
- Proficient in drug safety regulations domestically and preferably internationally including relevant GVP/GCP/ICH guidelines
- Technical knowledge of commercial drug safety databases, MedDRA and WHO Drug coding
- Experience with vendor oversight and management
- Clinical and analytical knowledge in relevant therapeutic areas
- Demonstrates excellent organizational and management skills
- Effective communicator with strong verbal and written skills
- Seen as a strong, influential leader and manager of employees
- Creates strong morale and spirit on his/her team
- Able to think creatively; develop and execute within a fast-paced environment
Benefits
- Flexible work environment
- 10% domestic travel
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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