Drug Safety Lead
Proclinical is currently recruiting for a Drug Safety Lead with a pharmaceutical company located in Cambridge, MA.
- Interact and communicate 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 strategic oversight of aggregate safety reports for investigational and marketed products
- Collaborate with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reports
- Manage distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team
- Manage resource planning and ensures adequate support from internal team and vendor team to deliver all scheduled safety reports.
- Manage commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies.
- Provide strategic 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
- Liaise with Regulatory Affairs to coordinate synchronization of aggregate reports
- Establish and chair 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 of experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports.
- Minimum 3 years of experience working with CROs, vendors, and relationship management preferred.
- Excellent organization skills and ability to prioritize individual and teamwork loads
- Expert knowledge of Global regulatory requirements
- Experience in vendor management for outsourced activities
- Ability to work in a dynamic environment and manage competing priorities
- Understand safety data capture in clinical trials and post marketing settings
- Good written and verbal communication skills
- Ability to work under strict deadlines and changing priorities with minimal supervision
- Excellent negotiation, conflict resolution, decision making, problem solving and critical thinking skills
- Experience with and demonstrated success in working on cross-functional diverse teams required
- Ability to interpret, analyze and clearly present scientific and technical data
- Scientific / medical writing (including word processing and data presentation packages (i.e. Word, Excel)
- Ability to thrive in a global matrix environment
- Experience with aggregate analysis and writing PSUR's, PADER's and DSUR.
- 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 contact Nikki Ranieri at 215-531-5288 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.