Our client is a clinical-stage biopharmaceutical manufacturing company. They have asked us to assist them in their search for a Safety Physician.

Major tasks and responsibilities include:

• Develops proactive patient-centric risk management strategies for the product.
• Is responsible for the benefit-risk and product risk minimization for investigational compounds.
• Plans, manages, analyzes, and monitors Safety/PV activities for study medications.
• Oversees CRO medical monitor or directly monitor study safety related activities.
• Establishes safety analyses in the clinical trial and safety databases for monitoring.
• Is accountable for serious adverse events (SAEs) review and safety report.
• Is responsible for safety issue management, including responding to safety-related questions from regulatory agencies, stakeholders, and other parties as needed.
• Provides clinical support for required regulatory submission.
• Provides interpretation of clinical trial safety data for clinical trial reports, publications, and submission documents.
• Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.
• Provides updates of the drug’s safety profile to Senior Management.
• Leads a monthly safety data review meeting and provides guidance to clinical team as needed.
• Provides updates of the drug’s safety profile to Senior Management.
• Contributes to process optimization as needed.

We seek candidates with the following qualifications:

• A Medical degree with sound clinical or research experience is required.
• Must have at least 10 years of profound experience in Pharmacovigilance and Risk Management in pharmaceutical company or biopharma. Experience at a global/international level is preferred.
• Requires significant experience and knowledge of clinical development and post marketing regulation, interactions with regulatory agencies, regulatory submission experience.
• Must have a sound knowledge of pharmacovigilance and safety for non-clinical and clinical development.
• Requires leadership and project management competencies.
• Related experience working in the Oncology target therapy is preferred.
• Excellent working knowledge of ICH, GCP and FDA/EMA guidelines/regulations is required.
• Must exhibit a “can-do” attitude, “out-of-the-box” thinking and good attention to details.
• Must have excellent managerial, organizational and negotiation skills.
• Excellent verbal and written communication skills are required.
• A proven track record of success in a leadership role is required.
• Must be an energetic individual, eager to manage multiple activities and priorities.
• Requires dedication to quality in all work tasks and deliverables in a timely manner.
• Requires flexibility working with global teams in different time zones and be able to travel per business request.

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 and Forbes' list of Top 200 Best Executive Recruiting Firms.