Executive Director, Drug Safety & Pharmacovigilance
AVANIR Pharmaceuticals in Laguna Hills, CA
- Industry: Pharmaceutical/Biotechnology - Medical Affairs
- Type: Full Time
- Compensation: $135,675.00 - 141,430.00 / Year*
The position requires in-depth subject matter expertise, strong operational strategic thinking and leadership skills to effectively manage safety and global pharmacovigilance resulting in regulatory controlled deliverables to both internal and external partners. This includes knowledge of global regulatory requirements for adverse event reporting during clinical development and post-marketing, and relevant experience in medical review, signal detection, risk management, and benefit-risk assessment in the context of aggregate reports (PBRER, DSUR, etc.). Additional areas of expertise: authoring experience for risk management plans, DSURs and PSURs in PBRER format/PADERs; safety input/review of clinical protocols, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA.
Essential Job Functions:
Oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
Perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products
Author or contribute to safety sections of clinical investigator brochures, protocols, inform consent forms, CSRs, integrated summaries of safety, core safety information, labels and regulatory reports with focus on providing overview for the medical analysis and safety sections.
Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
Support quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.
Provide expertise on PV operational processes to clinical, developmental and marketing teams, plus other stakeholders as required.
Participate in inspection readiness activities and preparation as needed
Stay current with international pharmacovigilance requirements and guidelines Drug Safety and Pharmacovigilance Team Lead:
Represent department at applicable Avanir and Otsuka leadership team meetings
Attend required inter-departmental and project team meetings
Ensure timely communication and exchange of information with PVG team
Coordinate with Avanir and Otsuka on inspection readiness and ensure team inspection readiness
Align cross-functionally within Avanir
Ensure all Otsuka and Avanir required trainings are completed, for self and the team, within assigned timelines
Lead quarterly Avanir Safety Advisory Committee meetings and oversee Adverse Event and safety review and coding of the ongoing programs in clinical development.
Coordinate Avanir SAC with Otsuka Safety Surveillance
Contribute to DSMB meetings
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
Medical degree (e.g. MD, MBBS)
Minimum of 10 ? 18 years of experience in a relevant clinical environment
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
Able to work across therapeutic areas and functions
Works collaboratively (establishes shared purpose across boundaries)
Develops people and the organization (invests in long-term development of others)
Proficiency with Microsoft Word, Excel, PowerPoint.
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver?s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies.? The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
Associated topics: climate, clinical, emr, environment, gauge, healthy, hospital, physician, safety, wastewater treatment plant
* Estimated salary
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