Senior Manager/Associate Director, Pharmacovigilance Aggregate
Proclinical is currently recruiting for a Senior Manager/Associate Director of Pharmacovigilance with a pharmaceutical company located in Boston, MA. Successful candidate will be responsible for the development, implementation and maintenance of robust procedures for the planning, preparation and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements.
- Provides leadership to regional aggregate reporting team including training, mentoring, development and appraisals
- Assists in management of departmental budgets
- Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally
- Interacts and communicates effectively internally and cross-functionally in a highly matrix environment.
- Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate report and other functional deliverables are completed with high quality
- Responsible for global leadership and strategic oversight of aggregate safety reports for investigational and marketed products
- Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc) contributing to aggregate safety reports
- Provides strategic and financial oversight of Vendor and manages both quality and compliance of assignments, including training and mentoring when appropriate
- Oversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics team
- Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findings
- Support continuous improvement/quality system initiatives
- Assist in preparation and support of audits and inspections
- Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports
- Establishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary
Skills and Requirements:
- Bachelors required. Degree in scientific/medical field or advanced degree preferred
- Minimum 8 years pharmaceutical or health care related industry experience required; previous experience working in global environment preferred.
- Minimum 5 years' experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports.
- Minimum 3 years' experience working with CROs, vendors, and relationship management preferred.
- Minimum of 2 years of line management or matrix management required
- Demonstrated experience in people management and well-developed skills in teambuilding, motivating and developing people.
- Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis
- Knowledge of case processing and aggregate reporting requirements.
- Demonstrated proficiency with computer applications and understanding of safety data.
- Knowledge of pharmaceutical business, including drug development and regulatory aspects.
- Knowledge of US, EU and international regulatory/safety regulations and guidelines.
- Fluency in oral and written English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry at (+44) 207 4400 636 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.