Job description
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
Reporting to the Head of GPV, PV Operations Manager will be accountable for the execution of operational tasks and activities overseeing and supporting the Global PV organization and is a key contributor in growing and shaping Pharmacovigilance Operational & Quality Program. This role will be focused on study startup safety activities, regulatory compliance, inspection readiness and vendor management. Practically speaking, in this role, he/she will work independently and as part of a multidisciplinary project team and lead the PV activities on several programs, helping to guide decision making and timely completion of clinical trial tasks. This person assists and contribute building PV presence, aid in the establishment and execution of PV Quality strategy, support inspection readiness activities. The position will support Health Authorities Audits/Inspections (e.g., MHRA, EMA, FDA etc.) and provide oversight of the PV Quality audit program (e.g., Affiliate/ Vendor/Process Audits, etc.) and partner with Quality Lead. This role will support other R&D Quality GxP disciplines (GCP, GLP, and CSV) including proactive quality audits, contributions to Regulatory Intelligence activities and will proactively partner with functions teams (Clin Ops, Medical) to create a PV quality culture within Keros and help reach a sustained state of inspection readiness excellence.
Essential Functions/Responsibilities
- Provide functional expertise and Program level oversight of outsourced PV Activities globally, including set up and conduct of clinical studies from a PV perspective, CRO/vendor training and management
- Strategic input, including providing subject matter expertise for PV services in the planning and setup of contracts, including costing, budgeting, resourcing, workflow and process design and analysis
- Partners with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning
- Responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials
- Oversight of CRO/vendor case processing activities (monitoring data quality, queries, narratives); Responsible for tracking clinical trial SAEs and SUSARs, monitoring timelines for event processing in alignment with CRO/vendor KPIs; Manage and maintain compliance listings for all expedited reports; Track all PV CRO/vendor action items and requests
- Conduct quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions
- Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate
- Development of PV infrastructure documents (SOPs, work instructions, training materials)
- Represent Pharmacovigilance Operations on global Program/study teams
- Performs other duties as assigned
Education and Experience
- Bachelor's degree (preferably in a health-related field) required
- A minimum of 3 years of pharmacovigilance experience in Biotech, Pharma or a CRO
- Knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada
- Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks
- Prior experience in global or local PV operational activities in either pre and/or post marketing environments
- Prior experience supporting optimization and/or strategic transformation projects
- Excellent collaboration and interpersonal skills, an ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations
- Strong analytical skills, an ability to synthesize large amounts of data and/or complex issues into consumable, simple messages and develop tangible recommendations and/or actions
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Covid-19 Vaccination Policy: All Keros employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes two booster doses once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.