Senior Manager, Clinical Safety Surveillance GPV-US - United States
Senior Manager, Clinical Safety Surveillance GPV-US
703 - Pharmacovigilance
No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The Senior Manager, (PV) Clinical Safety Surveillance works closely with the Sr. Director PV Operations and Safety Surveillance, Clinical Operations Teams and GPV-HQ to design and deliver timely ongoing and comprehensive reviews of the safety data as well as to enable accurate assessment of risk to patients and impact on compound development. The Senior Manager, (PV) Clinical Safety Surveillance is responsible for planning and managing processes that ensure timely, efficient collection and reporting of safety data to regulatory agencies and partners. This incumbent interacts cross-functionally within PV as well as with other departments within Lundbeck, which includes but is not limited to Regulatory Affairs, Clinical Operations and Clinical Research Organizations, outside consultants and vendors. The Senior Manager, (PV) Clinical Safety Surveillance assesses data from a medical perspective to identify signals for further study, trains and directs the team responsible for day-to-day evaluation of data and prepares reports and assists with investigator training as required.
The Senior Manager, (PV) Clinical Safety Surveillance ensures that teams are adequately staffed and trained including the availability of facilities, processes and systems. She/he collaborates within the department, with other Lundbeck LLC departments, Global Pharmacovigilance Headquarters (GPV-HQ) and with partners to ensure regulatory compliance and achieve business objectives.
- Designs and develops standard processes and procedures to ensure the comprehensive, timely and efficient review of safety data obtained from Lundbeck compounds under investigation.
- Manages clinical safety case review and other safety review activities in collaboration with functional areas within PV and outside of the department, to enable timely safety data monitoring.
- Manages in-depth serious adverse event (SAE) investigation, SUSAR reporting, quarterly safety review to identify safety signals, management of SAE reconciliation, analysis writing to enable accurate assessment of risk to patients and compounds in development.
- Ensures efficient and timely review and query resolution on safety data in support of R&D timelines.
- Manages timely, accurate and complete clinical study report SAE narratives are available to support clinical study activities.
- Provides operational support and works with PV Medical Directors on management of data safety monitoring committees and adjudication committees, review of safety sections of regulatory documents DSURs, laboratory alerts, and development of project-specific safety plans.
- Works with Clinical Operations to evaluate and select a CRO for outsourcing of PV clinical study activities when needed.
- Ensures project safety plans (CROS) are in place and serves as primary liaison to manage all PV activities in accordance with the safety plans.
- Manages clinical safety surveillance case processing to ensure quality and appropriateness of data collected in the global safety database in collaboration with functional areas within PV and outside of the department to facilitate product safety data and signal monitoring.
- Works collaboratively with GPV-HQ to address consistency in collection and investigation, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regulatory requirements and to drive improvements in global processes to enable accurate assessment of patient risk and regulatory compliance.
- Ensures compliance with all federal regulations regarding postmarketing and clinical regulatory reporting to the FDA and other health authorities and required reporting timelines as defined by the federal code of regulations and Volume 9A.
- Manages staffing for functional area and sets strategies for the recruitment, hiring, and mentoring of staff.
- Ensures the collection, investigation and timely preparation of reports for all adverse events (clinical) according to applicable regulations.
- Ensures review and approval of all triage assessments, coding assessments and determinations of reportability to an authority or partner are completed according to regulations and PV agreements.
- Identifies financial, technological, organizational, and human resource needs that must be met for clinical safety studies to meet functional and regulatory requirements.
- In collaboration with the Quality Management team, designs the training program(s) for functional area(s) and is responsible for ensuring proper employee training and documentation.
- Works with GPV-HQ and GPV-US to address consistency in collection, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in overall global processes.
- Ensures department compliance with Ethics Code of Conduct and all regulatory requirements, including documentation, validation, and if applicable, electronic signature.
- Manages Pharmacovigilance goals and facilitate goal process for Pharmacovigilance management.
- Ensures department goals align with goals of entire organization and GPV-HQ.
- Works with staff to train, motivate and develop them in their jobs and careers.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- An accredited Bachelor’s degree in Health Science, Nursing or related healthcare degree or Pharm D
- 5 + years of experience in a Pharmaceutical or Biotech company
- 3 + years of Safety/Pharmacovigilance experience
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- MBA/Master’s Degree or equivalent
- 2 + years of leadership, project management, program management or management experiences is desired
- Leadership competencies are required as well as management direct exempt/non-exempt staff.
- Experience in safety systems, safety surveillance, project management, personnel management, contracting and negotiations or a minimum of five (5) years of equivalent experience in pharmaceutical industry
- Excellent organization skills and ability to prioritize workloads
- In depth knowledge and comprehension of safety databases (ARISg), including database structures, operations, call center and complex case safety querying
- Knowledge of Pharmacovigilance reporting regulations and ability to interpret multiple requirements into concise clear instructions
- Excellent written and oral communication skills including ability to present to large internal/external groups and in particular demonstrated abilities in effective training and education of others
- Willingness to travel up to 5-10% domestically. International travel may be required.