Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Medical Director, Safety.
Major tasks and responsibilities will include :
Leads multidisciplinary teams regarding safety relevant topics.
Reviews safety data and literature through all phases of the life-cycle of medicinal products.
Serves as subject matter expert for safety relevant discussions with regulatory agencies and internal / external stakeholders.
Monitors and assesses the safety profile through systematic signal detection.
Provides expert advice and serves as expert witness to legal counsel regarding safety issues, as required.
Provides guidance to the clinical development teams regarding all aspects of clinical safety.
Serves as liaison with KOLs and license partners.
Responsible for coordinating Advisory Boards and Drug Safety Monitoring Boards.
Ensures timely delivery of all safety deliverables towards Clinical Study Reports.
Ensures timely preparations for market applications and all other regulatory documents.
Prepares and analyzes safety data for manuscript / publication submissions.
Analyzes safety relevant matters, escalates safety issues to the appropriate decision-making level and proposes solutions.
Provides strategic input to key stake holders in relation to product safety.
Investigates the safety profile of potential product acquisitions.
Ensures that all necessary requirements are included in pharmacovigilance agreements.
Actively participates in the continuous improvement of quality of processes, methods, and communications.
Reviews, prepares and / or contributes to safety relevant SOPs.
Contributes to the clinical safety risk management training and mentoring.
We seek candidates with the following qualifications :
Advanced degree (MD or equivalent) required.
Must have a minimum of 2 years of pharmaceutical industry experience within pharmacovigilance and / or clinical research / clinical safety.
Requires a minimum of 2 years of medical practice experience.
Solid understanding of clinical research methodology, clinical epidemiology / biostatistics, relevant regulatory framework, and pharmacovigilance tools and processes highly preferred.
Must have sound clinical acumen and a wide range of therapeutics expertise.
Requires the ability to synthesize and analyze safety data from various sources.
Expertise in international regulations governing drug safety highly preferred.
If interested, please email your resume as a Word attachment to us, reference 3839. No calls or faxes, 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.