Job Description

Position Overview:

The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse event (AE) reporting, and maintaining the integrity of safety data across clinical and post-marketing programs. This role oversees the timely and accurate submission of safety reports to health authorities, manages signal detection and risk assessment processes, and provides strategic input into safety management plans. The Director also leads cross-functional safety data reviews, collaborates with regulatory and clinical teams, and ensures continuous improvement of PV (pharmacovigilance) systems and procedures to uphold patient safety and regulatory standards. This role supports the development, implementation, and delivery of PV strategy for assigned projects, ensuring alignment with timelines, budgets, and quality standards. In the area of PV, the physician is expected to contribute to the overall strategy and approach within Medical Safety by assisting the department head. Note this position requires a Doctor of Medicine (MD).

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to Senior Director, Medical Monitoring and Pharmacovigilance.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• The successful candidate will provide PV technical support to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans.
• Major areas of responsibility include contributions to PV clinical data safety analysis and regulatory submissions.
• Reviews of clinical safety trial-related documents, such as CRF, PD, and MM Plan.
• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Vistagen standards.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed.
• Assist with development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author analysis of similar events (AOSE) and individual case comments for ICSRs.
• Maintain knowledge of global regulatory authority regulations including FDA.
• Represent and advise on Clinical Safety in team meetings.
• Establish good working relationships with investigators.
• Serve as a point of contact for trial sites for medical issues in clinical trials.
• Review and respond to questions from the trial sites regarding any safety queries, such as eligibility, laboratory findings, ECG, and concomitant medications; and maintain a medical decision log.
• Represent safety during Site Initiation Visits, Investigator Meetings, CROs, and other collaborators as requested.
• Collaborate in data cleaning activities, and development of Tables, Listings and Figures (TLFs) before database lock.
• Develop the proposed clinical milestones with the Clinical Sub-team.
• Develop strategies, working with the Head of Safety, to achieve PV Medical Safety goals.
• Along with the Head of Safety, represent PV in communications with health authorities such as the FDA.
• Assess safety signals and trends and proactively manage any potential safety issues.
• Organize Safety Management meetings (SMM) to maintain a periodic analysis of study-related safety data in Vistagen-sponsored clinical trials, assessing safety concerns, anomalies, trends, and discrepancies.
• Formulate response strategies and author responses for PV-related health authority requests.
• Assist with Medical Monitoring as needed on clinical trials.
• Assist with oversight of the vendor performing medical review of ICSRs and aggregate report on behalf of Vistagen.
• Perform medical review of serious adverse events from Vistagen clinical trials and lead the development of SAE narratives in collaboration with the CRO and Vistagen Clinical.
• Accountable for medical evaluation/interpretation of aggregate safety data of assignment product(s) including signal detection and evaluation, and ad hoc safety assessments.
• Provide oversight for the safety aspects for clinical studies, and development and maintenance of the company's core safety information.

Qualifications:

• MD required, neurology, psychiatry, or CND-related disease experience is a plus.
• Minimum 5 years of relevant drug safety experience in the pharmaceutical industry, or equivalent.
• Highly developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
• Working knowledge of validated drug safety databases, MedDRA and WHO.
• Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
• Extensive experience in authoring all types of aggregate safety reports including setting a strategy to address potential safety issues.
• In-depth understanding of the drug development process.
• Exceptional written and verbal communication skills.
• Ability to build and sustain trusted relationships both internally and externally.
• Proficient computer skills, including Microsoft Word, PowerPoint, and Excel.

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid holidays
• Mental health days
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $260,000-$290,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at .

Job Tags

Full time, Casual work, Remote work, Flexible hours, Weekend work, Afternoon shift,

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