Associate Director, Patient Safety
Location: United States - Remote
Salary: $155,000 - $165,000+ Bonus
The Associate Director of Patient Safety will assume a leadership role and collaborate within a team to review Individual Case Safety Reports (ICSRs), prepare periodic safety reports, and offer strategic and tactical counsel and guidance in pharmacovigilance for the organization's products. This position will actively engage with the entire Patient Safety team to provide strategic supervision at both the national and international levels, ensuring compliance with periodic safety reporting for global pharmacovigilance (PV) and safety monitoring across the organization. Additionally, this role will collaborate closely with the Technical Complaints team to ensure comprehensive medical support for all investigation aspects.
Duties and Responsibilities:
- Provide supervision and guidance for both global and local pharmacovigilance (PV), in collaboration with Business Partners and external service vendors.
- Collaborate with PV service providers, patient support programs, and customer support teams to ensure compliance with all pharmacovigilance regulations.
- Take responsibility for managing Pharmacovigilance requirements, including the EU Risk Management Plan (EU-RMP), as well as the development and upkeep of Standard Operating Procedures (SOPs) and Work Instructions (WIs). Additionally, create and maintain global and local Risk Management Plans (RMPs) when necessary.
- Engage in a cooperative effort with other PV experts within the firm and Business Partners, contributing insights for team decision-making processes.
- Function as a primary point of contact for all pharmacovigilance-related matters.
- Take charge of supervising the company's global pharmacovigilance outsourcing activities, encompassing tasks such as identifying, selecting, negotiating, managing, and sustaining Good Pharmacovigilance Practices and the necessary pharmacovigilance tasks for designated projects or therapeutic areas.
- Foster collaboration with various departments, including Regulatory, Clinical, Quality Assurance (QA), and Legal, as required. Furnish management with pertinent safety-related information when necessary.
- Exercise oversight over the management of Individual Case Safety Reports (ICSR) and aggregated safety reports for Business Partners and contracted services.
- Engage in a cooperative effort with the outsourced vendor to facilitate the execution of periodic aggregate safety reports (e.g., ASR, PBRER, etc.), assuming responsibility for both oversight and authorship when appropriate.
- Assess the existing signal detection processes and propose enhancements for ongoing improvement.
- Contribute to the continuous assessment and analysis of safety data for commercial products by examining adverse events and signal detection findings. Conduct a rigorous evaluation of signal detection data, review summary metrics, and compliance reports, and disseminate reports within the firm following internal Standard Operating Procedures (SOPs).
- Aid in updating the Company Core Data Sheet (CCDS), Canadian Product Monograph(s), and the US Package Insert for the company's products as necessary. Additionally, provide support for label modifications required in partnership with business partners in specific regions.
- Take the lead in responding to regulatory agencies regarding pharmacovigilance matters in relevant territories related to the firm's products. Provide or coordinate medical opinions in response to Individual Case Safety Report (ICSR) inquiries.
- Assist in the oversight of the development and updates of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) for Market Authorization Holders (MAH) as required to ensure compliance with regulations. Verify adherence to all SDEAs and PVAs.
- Participate in both internal and vendor team meetings.
- Elevate issues and propose mitigation strategies for pharmacovigilance concerns.
- Integrate cutting-edge industry initiatives aimed at enhancing the efficiency of surveillance, signal detection, and risk mitigation activities for both marketed and emerging therapies.
- Take charge of internal and external audit and inspection activities, ensuring audit and inspection readiness. Foster preparedness for regulatory authority inspections and internal audits pertaining to aggregate reporting processes.
- Provide support for local literature searches, searches within the Canada Vigilance database, and monthly reconciliation.
- Assist in fulfilling training requirements for pharmacovigilance within the relevant company territories.
- Undertake any other responsibilities as assigned.
- Proficient at fostering collaborative and effective interactions within a team setting, including collaboration with colleagues from Clinical Development, Regulatory, Quality Assurance, and Legal departments, as well as external partners and vendors.
- Possesses strong leadership capabilities and the ability to coach, educate, and mentor employees effectively.
- Demonstrates expertise in international Good Pharmacovigilance Practices (GVP) and the management of vendor relationships.
- Exhibits well-honed oral and written communication skills.
- Displays strong skills in conflict resolution and problem-solving.
- Capable of working both independently and within cross-functional teams.
- Skillful at managing and prioritizing multiple projects and tasks, showcasing excellent organizational and time management abilities in a fast-paced environment.
- Proficient in computer skills, with a proven track record of working with Microsoft Office suite programs such as Word, Excel, PowerPoint, Project, and Outlook.
- Strong preference for candidates with a PharmD, MD, or DNP degree (Bachelor's in a medical discipline may be considered if accompanied by additional experience in the Pharmacovigilance industry).
- Possess an appropriate advanced medical degree and accumulate 8-12 or more years of experience in the field of pharmacovigilance.
- Must have extensive exposure to tasks such as preparing, authoring, and submitting international periodic aggregate safety reports, conducting ICSR analysis, engaging in signal detection and risk management, and handling literature reporting within a Pharmacovigilance setting.
- Demonstrated and recent hands-on involvement in post-marketing pharmacovigilance, as well as experience in managing vendors for outsourced pharmacovigilance activities.
- Direct familiarity with both national and international pharmacovigilance regulations and requirements.
- Proven ability to work effectively and productively in a dynamic work environment.