Manager, Clinical Safety
Our client is a biotechnology company. They have asked us to assist them in a search for a Manager, Clinical Safety.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Performs safety reviews of Adverse Event reports for company products.
- Performs ongoing surveillance of safety data from the company’s clinical trials.
- Acts as the primary safety contact for other departments and ensures appropriate and timely handling of safety issues.
- Provides safety review and input to various documents.
- Helps with the development of other documentation such as: Development Safety Update Reports, Investigator’s Brochures, and Subject Informed Consent.
- Establishes and manages external Data monitoring Committees (DMCs) for early phase trials.
- Contributes to the planning and conduct of Safety Committee activities.
- Conducts safety training of employees, CROs, Investigators and other relevant site personnel as necessary.
- Contributes to multidisciplinary project groups for assigned products.
- Contributes to the development and optimization of new tools and processes.
- Interacts with safety and clinical CROs, performs sponsor oversight activities for safety related tasks, processes invoices, and ensures regulatory compliance (including regulatory reporting requirements) for assigned products.
- Oversees Safety Data Exchange Agreements with partners as required.
- Collaborates with external experts and partners.
- Completes ongoing surveillance of new and updated regulations and evaluates the impact of drug safety processes for the company.
- Ensures compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections.
- Participates in audit and inspection activities as required.
- RN or BSN is required.
- A medical degree is preferred.
- Requires a relevant Life Science background.
- Must have a minimum of 3+ years of relevant experience.
- Experience within the field of oncology and/or first human trials is preferred.
- Must have proven experience from supervising multiple trials with safety inputs at the Global level.
- Requires international experience from a similar role with internal and external stakeholders.
- Must have experience with vendor management.
- Excellent communication skills in both written and spoken English is required.
- Must be a strong communicator and must be good at building professional relationships with collaborators and business partners.
- Must be proactive and able to prioritize work in a fast paced and changing environment.
- Must be result-and-goal- oriented and committed to contributing to the overall success of the company.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.