Head of Pharmacovigilance and Drug Safety (MD, DO)

Company Name

Savara Inc.

Role Overview

Reporting to the CMO, Savara is seeking a MD/DO Head of Global Pharmacovigilance (PV) and Drug Safety to join a team of enthusiastic, creative, and driven individuals to head the global drug safety and pharmacovigilance function. The individual should have at 10-15+ years of experience in the evaluation of adverse events in clinical trials, post marketing surveillance and global pharmacovigilance reporting. Experience working with 3rd party PV vendors to ensure accurate and timely reporting to regulatory authorities is a requirement.

Core Responsibilities

• Develop therapeutic Area (TA) and product expertise.
• Provide close oversight of PV vendor for named patient/expanded access program.
• Work with PV vendor to develop a system for post-marketing surveillance (US, EU, UK and ROW).
• Oversee and ensure seamless transition of clinical trials database(s) to the chosen external vendor for post-marketing safety surveillance.
• Lead the Savara Development Safety Team, to ensure the oversight of company medicinal products.
• Lead the PV governance and compliance strategy.
• Be accountable for execution of all safety related processes.
• Provide oversight of all PV-related systems.
• Be accountable for compliance with global regulatory requirements.
• Provide oversight of PV personnel and vendors.
• Work with Quality Team to evaluate and revise processes related to PV reporting.
• Interface with regulatory authorities and PVQP to ensure timely submissions of required events and support quality audits.
• Be accountable for audit findings and CAPAs where required.
• Participate in safety oversight of clinical trials, including collaboration with the medical monitor regarding clinical trial safety listings and attending medical monitoring meetings for ongoing clinical trials.
• Build relationships with internal stakeholders in Medical Affairs, Quality, Clinical Development and Clinical operations to ensure accurate and timely reporting of safety issues and escalation, as appropriate.
• Review clinical safety data and summaries for regulatory filings.
• Review and establish SOPs in preparation for regulatory authority inspections.
• Represent Savara externally as a key medical expert on safety of Savara products.
• Contribute to company success through both internal (e.g., Medical, Sales and Marketing, Market Access, and Public Affairs) and external medical education and medical/scientific information exchange and support, as well as use their medical/scientific expertise to ensure safety information is communicated internally and externally.
• Operate in a confident and compliant manner within a highly regulated environment.
• Stay up to date with therapy advances, current research, medical scientific knowledge, and detailed knowledge of Savara’s products’ relevant disease areas.

Supervisory Responsibilities

• Interview, hire, and onboard direct reports.
• Develop talent and align on goals and development opportunities.
• Provide constructive and timely ongoing feedback.
• Motivate and direct work.
• Lead cross-functional teams, and manage, coach and grow direct reports.

Key Qualifications

• Doctorate degree (MD, DO) with at least 10 years of global Pharmaceutical/Biotechnology drug safety/ Pharmacovigilance experience.
• Ability to understand and effectively communicate scientific and medical information to both internal and external customers.
• Excellent written and oral communication skills are imperative. Ability to anticipate and adapt to change; strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
• Excellent analytical, problem-solving and strategic planning skills.
• Ability to work independently yet engage in collaborative decision making to complete tasks in a timely fashion, and function in a rapid-paced environment.
• Ability to communicate well with HCPs.

Work Schedule and Location

This role will be remote within the United States. Occasional travel to the corporate office outside of Philadelphia, PA and as needed- travel to vendor locations domestically and internationally will be required. The employee must be able to work a US eastern time schedule.

Benefits

Savara provides Comprehensive Benefits including:

• Medical, dental, and vision coverage.
• Flexible Spending Accounts for health care and dependent care expenses.
• Paid time off and paid holidays, including Dec 24-Jan 1.
• Paid parental leave.
• 401k with highly competitive match.
• Life, AD&D, STD and LTD insurance coverage.

Compensation

Savara’s compensation can include a base salary, bonus, and equity. This role will be filled either at an Executive Director or Vice President level and the base salary range is $340,000 to $390,000.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.