Vice President, Drug Safety & Pharmacovigilance
Our client is a biotechnology company. They have asked us to assist them in a search for a Vice President, Drug Safety & Pharmacovigilance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities across the company’s portfolio.
- Supports safety operations to establish and maintain policies and procedures for the Clinical Drug Safety Department.
- Provides oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
- Ensures that data safety signals are identified and communicated appropriately.
- Ensures ongoing evaluation of the overall safety profile for the organization’s investigational products.
- Serves as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
- Supports both Medical Science and Clinical Operations teams with respect to safety related issues as required.
- Provides input and review of responses to regulatory agency questions with regard to safety and pharmacovigilance activities.
- Provide support for safety sections of clinical documents.
- Assesses global PV requirements for resources, equipment and systems to maximize efficiency.
- Supports development and maintenance of product benefit-risk profiles.
- Collaborates with the business development team regarding the direction for business development plans and strategies.
- A Bachelor’s Degree in life sciences or related discipline is required, a medical or relevant advanced degree is strongly preferred.
- Pharmacovigilance experience, including regulatory filing experience within the biotechnology or pharmaceutical or related industry is required.
- Must have 7+ years of relevant industry experience including experience leading multidisciplinary teams.
- Requires demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
- Robust knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding is required.
- Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) is preferred.
- Must have the ability to evaluate and interpret serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
- Must have excellent clinical judgment and the ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes is required.
- Entrepreneurial, small/high-growth company experience is preferred.
- Must have attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Must possesses strong written and verbal communication skills.
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.