Hobson Prior is working closely with a Biopharma company who is seeking a Medical Safety Operations Consultant to lead operational activities ensuring compliance with all relevant regulations and safety of product development. This interim leadership role includes providing direction for the operations department during a time of change and exciting product development.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Lead safety operations with the support of a small team.
• Ensure adherence to all global regulatory requirements.
• Identify changes in regulatory requirements and ensure the team is aware and takes appropriate action.
• Lead process improvements within safety and cross-functionally to improve compliance as needed.
• Oversee and monitor compliance of external service providers.
• Support the development of safety infrastructure including new safety projects, and set up applicable safety systems.
• Serve as internal quality contact and provide support for external and internal audits and inspections.
• Oversee deviation and corrective and preventive action activities.
• Represent the Medical Safety Department in cross-functional meetings or working groups as needed.

Requirements

• Degree in Pharmacy, Nursing, or Life Sciences.
• Experience in various drug safety and pharmacovigilance positions, with increasing seniority and including leadership experience within safety operations.
• Knowledge of safety requirements for US as well as EU / UK. Experience with other agencies globally would be a plus.
• Experience in preparing teams for, and leading teams through inspections and subsequent corrective and preventive actions.
• Experience in leading process improvements within safety departments and cross-functionally.
• Ability to adapt to rapidly changing environment and think strategically.
• Broad knowledge of pharmacovigilance needs within a drug development environment.
• Expert knowledge of general drug development process.
• Excellent team player, able to deliver against a tight deadline and in a demanding environment.
• Excellent writing and communication skills.
• Fluent in English, working knowledge of other international languages beneficial.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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