Medical Director, Clinical Safety
Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Medical Director, Clinical Safety
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Leads involved monitoring and continued evaluation of safety profile through signal detection.
- Evaluates safety data and literature during all phases of a defined portfolio.
- Directs the clinical development teams in all phases of clinical safety.
Sets up and coordinates specific boards and communicates with KOLs.
- Delivers all safety deliverables in a timely manner in preparation for market applications and other regulatory documents.
- Leads multidisciplinary teams regarding safety relevant topics and heightens all safety relevant matters to the appropriate level with proposals for solutions based on analysis of the available information.
- Provides strategic input to key stake holders in relation to product safety.
- Understands the strategy for the product and knows about the context of the respective product class.
- Acts as the accountable content owner for all safety pertinent content or safety documents during clinical development and post approval.
- Acts as content owner for safety relevant communications.
- Performs inquiry into safety profile of possible new products and ensures that all conditions are incorporated in safety agreements.
- Participates in continuous improvements of quality of processes, methods and communication.
- Interfaces with other departments with regard to safety aspects.
- Acts as expert for safety pertinent discussions with regulatory agencies and other agencies.
- Delivers expert advice to legal counsel and other teams concerning safety issues.
- Educates and guides in clinical safety risk management.
- Analyzes and prepares safety data for manuscript and/or publication submissions.
- Contributes to quality improvement: Reviews, prepares, and/or updates local and global SOPs and working instructions as required.
- Medical Degree or foreign equivalent plus accredited residency is required.
- Requires a minimum of 2 years of experience as a physician in patient care.
- Must have 3 years pharmaceutical/biotechnology industry experience, including 1 year with accountability for medical oversight/evaluation or clinical development.
- Experience and success in addressing and managing complex medical issues is required.
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.