Medical Director, Pharmacovigilance & Risk Management

Medical Director, Pharmacovigilance & Risk Management

Reporting to: Vice President, Pharmacovigilance & Risk Management

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will ...

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of Pharmacovigilance to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Accountabilities and Responsibilities:

The Medical Director, Pharmacovigilance & Risk Management will serve as the medical expert for the pharmacovigilance team in the management of safety signals, risk management activities, and benefit-risk analysis and will contribute to the development of pharmacovigilance strategies for monitoring the safety profile in support of X4 drug products. The qualified candidate will have experience in and will perform multiple activities related to the overall medical oversight of global pharmacovigilance activities including ICSR management, signal detection and management, and aggregate safety report development.

• Perform medical review of Individual Case Safety Reports (ICSRs) from clinical trials and postmarketing spontaneous and solicited reports to determine the event seriousness, expectedness, company causality, for the proper medical assessment and evaluation of cases.

• Provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and postmarketing surveillance, ensuring that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment.

• Develop targeted queries and ensure PV queries are issued as appropriate for SAEs/SUSARs/AESIs and make urgent follow-up medical queries in coordination with Medical Monitors when necessary.
• Lead the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.
• Lead the multidisciplinary Safety Review Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
• Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (IB), national labels).
• Contribute to CSRs and analysis of safety tables, figures, and listings and cases from clinical studies.
• Lead the medical content and review of aggregate safety reports (DSUR, PADER, PBRER) with the third-party pharmacovigilance vendor.
• Analyze, prepare, and present safety data for Drug Monitoring Committees, as applicable.
• Participate in development of safety-related responses to queries from Regulatory Authorities.
• Develop and implement department SOPs and work instructions related to the PV &RM medical processes.
• Act as Subject Matter Expert (SME) supporting internal and external audits and inspections from regulatory agency and business partners as required.
• Other relevant duties as assigned.

Requirements: Proven Experience, Skills, and Education:

• MD from an accredited medical school or equivalent.
• Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry including medical case review, signal evaluation, and development of aggregate safety reports.
• Direct experience in pharmacovigilance including knowledge of regulatory requirements and guidelines in US and, the EU, and globally.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate (verbally and in writing) complex clinical/pharmaceutical information and safety data.
• Knowledge of MedDRA terminology and its applications.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies.
• Must be able to work on multiple projects simultaneously.
• Ability to prioritize work without much support.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Experience working within Safety databases (e.g., ARGUS, ARISg)
• Proficient in Microsoft Office Suite and function and technical understanding of other pharmacovigilance systems and tools

This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

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X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.

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