Senior Manager of Global PV Operations
A global biopharmaceutical company is currently seeking a proactive, responsible, Senior Manager (contractor) to report to the Head of Global PV Operations in Palo Alto, CA. You will have the chance to support all safety management aspects and oversee PV vendor projects. Additionally, you will use your expertise to advise case processing activities. Are you detail-oriented, hold strong accountability, and are passionate about using technology for continued innovation? If so, please reach out to learn more. The Senior Manager Global PV Operations will be responsible for: Participating actively in Study Management Teams (SMTs) as a representative of the PV Operations team Monitoring PV vendors to account for ICSRs, SOPs, and various safety reports Oversee creation of programs and SP vendors to ensure rollout of MAPs and other action plans The Senior Manager Global PV Operations should have the following qualifications: Bachelor's in health care field with experience in drug safety At least 3 years of experience in Pharmacovigilance Mastery in FDA regulations, ICH guidelines, and other regulatory documents Can travel up to 20% for the job domestically and internationally Benefits Medical and dental insurance 401K If you are interested in the Senior Manager Global PV Operations role, apply today!
US$80 - US$90 per hour
Associate Director of Patient Safety
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. Qualifications: 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.
United States of America
Pharmacovigilance Medical Director
Medical Director, Pharmacovigilance Location: Massachusetts - Remote Salary: $215,000-$250,000 + Bonus A commercial stage biopharmaceutical company is seeking a Medical Director of Pharmacovigilance. It operates globally, focusing on unaddressed skeletal health needs. The firm collaborates resolutely to enhance patient and family lives. Its assets include commercial and clinical development, spanning mid to late-stage drug candidates. This person will person will be in charge of global pharmacovigilance for the company's clinical and post marketed products including review and analysis of data from clinical trials, advising on project teams using their medical expertise, identify safety signals and manage the risk benefit section and review aggregate reports. Duties and Responsibilities: Maintains an advanced understanding of safety matters, encompassing emerging concerns and the risk-to-benefit profile for relevant compounds. Also, upholds familiarity with regulatory directives in connection to drug safety and pharmacovigilance. Oversees the assessment of Individual Case Safety Reports (ICSR), ensuring the precision and completeness of safety information. This involves evaluating factors such as severity, predictability, and causal relationships, as well as coding, narrative summary review, and provision of case insights. Offers medical responses for further inquiry. Engages in collaborative efforts with individual project teams, delivering medical insights and expertise. Leads safety signal identification initiatives for designated products, and as required, discusses these signals within the context of the Safety Review Team (SRT). Plays an integral role in the creation and assessment of comprehensive reports (DSUR, PSUR, RMP, ad-hoc safety reports), including furnishing authoritative medical evaluations. Responsible for composing pertinent safety sections and weighing risk-benefit elements within aggregate safety reports. Supplies medical perspectives and safety-related inputs for inquiries from regulatory entities, IRBs, ethics committees, etc. Presides over the Safety Review Team (SRT) dedicated to the applicable products, coordinating effectively with varied internal and external stakeholders. This involves the management of newly surfaced safety signals from both post-marketing and clinical trial domains. Cultivates robust communication channels and fosters relationships with diverse stakeholders, including PV Vendors and Radius Partners, with a focus on pharmacovigilance matters. Sustains the updating and refinement of the benefit-risk assessment for assigned products across their lifecycle. Contributes to and assesses safety sections within study reports, protocols, consent forms, company core data sheets, investigator brochures, NDA/MAA clinical summaries, and product labeling. Participates in cross-functional and project-specific team gatherings, offering medical expertise when required. Achieves departmental goals by overseeing and guiding team members. Plans, arranges, and supervises departmental functions to ensure the attainment of objectives. Nurtures team members by strategically recruiting, selecting, orienting, and training personnel. Works collaboratively with team members to identify internal growth prospects. Sustains a continuous evaluation of team performance and provides guidance to enhance competencies and knowledge. Ensures adherence to all regulatory mandates and consults with human resources regarding matters of employee relations. Note: Some travel may be necessary for this role. Qualifications: MD or DO required 5 - 10 years of experience in the Pharmaceutical Industry within Drug Safety Direct experience with clinical practice preferred Experience in Global Drug Safety required Proficiency in ICH/FDA guidelines for GCP as well as for clinical and post marketing safety reporting Capacity for comprehending, examining, and interpreting scientific and technical literature Competence in evaluating and reviewing post-market and investigational events, along with the capacity to manage documentation and assessments for aggregate reports. Proficiency in drafting/overseeing Annual Reports, PSURs, and Type II Variations is essential. Familiarity with MedDRA coding and methods for retrieving case series data Adeptness in thriving within a dynamic work environment, showcasing the ability to manage numerous concurrent tasks and priorities Ability to collaborate with international partners and Contract Research Organizations (CROs) Possession of exceptional English writing skills and adept verbal communication, both in conversation and presentation Proven capabilities in decision-making and troubleshooting, coupled with a proactive mindset
United States of America