Senior Director Of Pharmacovigilance

Reports to: Chief Medical Officer
Location: Remote/ Hybrid
Company Overview:
Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.
At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.
Position Summary:
This position is responsible for leading the Pharmacovigilance & Drug Safety programs at our organization. This position partners and collaborates with Braeburn's development partner.
This role will be held by a pragmatic and collaborative leader with a deep understanding of the drug safety landscape and will provide medical oversight for pharmacovigilance, drug safety, case management and risk management for investigational and marketed products, while ensuring compliance with regulations, compliance with company policies and procedures, and overseeing the assessment of the safety profile of all products, signal detection and the mitigation of potential safety risks.
Specific Duties:

• Directs the development and preparation, while ensuring the timely submission, of regulatory safety reports, investigator communications, product labelling/ package inserts, and other reports including reports for company management.
• Represents the department as the medical safety lead on cross-functional study and program teams for assigned products and studies, while providing expert guidance regarding safety matters and issues.
• Oversees Pharmacovigilance Contractual Service Provider (CSP) to ensure delivery of high-quality individual case safety reports, regulatory submissions, literature review, aggregate reports, signal detection, and any other services contracted to such providers.
• Regularly evaluates the performance of CSP(s) to ensure high quality service provision, including regular monitoring of KPIs and review of ICSRs and contracted reports.
• Participates in clinical trial protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
• Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
• Contributes to preparation and review of periodic reports (PADER, IND, Annual Safety, DSUR, PSURs, CSR).
• Reviews and provides medical content, as needed, for key study-related documents, e.g., IB, ICF, IDMC Charter.
• Serves as a member of the Labeling Review Committee and the Investigator Initiated Trial grant review team.
• Represents the drug safety function in clinical development of the assigned product(s) including clinical development plans, clinical trial protocol development (inclusion/exclusion criteria, collection, and monitoring of safety data), statistical analysis and reporting of study data.
• Reviews Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required).
• Provides guidance to staff and/or vendors regarding optimal practice regarding collection, evaluation, and processing of adverse experience reports, from a medical perspective.
• Leads the Safety Review Team which is responsible for the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
• Interfaces externally with vendors (CROs, Medical Information, etc.), external Key Opinion Leaders (KOLs), investigators and study teams, independent researchers, consultants, scientific advisors and other key partners.
• Oversees the development or revision of Standard Operating Procedures (SOPs) and Work Instructions.
• Establishes and implements training protocols for overall pharmacovigilance and regulatory reporting.
• Works closely with the Quality organization to ensure a robust and high-quality Pharmacovigilance Quality System and to address any deviations, investigations, change controls, or CAPAs required to continuously improve that system.
• Serves on the Chief Medical Officer's Leadership Team (CMOLT), providing strategic leadership within the CMO's organization that prioritizes patient safety and places it at the center of everything we do.

Skills:

• Excellent critical data analysis skills
• In-depth knowledge of Pharmacovigilance regulations including FDA/EMA requirements
• In-depth understanding of Pharmacovigilance processes, regulatory compliance, and standardization
• In-depth knowledge of risk evaluation and mitigation strategies (REMS) and risk management program (RMP) systems
• Expertise in clinical safety assessments, safety signal detection, aggregate reporting, and risk management, including interactions with regulatory authorities
• Ability to interpret, synthesize, and communicate complex clinical and pharmaceutical information and safety data
• Demonstrated excellent organizational and planning capabilities
• Demonstrated clear and effective verbal and written communication skills
• Experience working with an electronic Quality management system, including implementation of change controls and CAPAs

Education/Experience:

• MD/DO degree with a minimum of 12-15 years of pharmaceutical industry experience.
• Minimum of 5 years of running a Pharmacovigilance Department or 7-10 years of supervising a team of Drug Safety professionals.
• Experience in direct interaction with key regulatory agencies (US and non-US).
• Ability to work in a hybrid work environment.

Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented classes to apply for any open job positions with the company.
Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA) ; Know Your Rights Poster ; and Employee Polygraph Protection Act (EPPA).