Associate Director, Pharmacovigilance (Nottingham, UK)
Responsible for providing management level oversight to assigned staff and projects, overseeing the delivery of pharmacovigilance (PV) services in accordance with applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.
Serves in a global leadership capacity within the department, collaborating with department leadership on the ongoing development and implementation of efficient processes, staff development and technology advances. Key contributor to the strategic development of the PV department. May serve as a PV leadership representative on key committees and initiatives at a corporate level.
Tasks may include but are not limited to:
- Provide management of staff and projects including ensuring:
- All pharmacovigilance activities are performed according to applicable regulations and processes
- Work is performed according to the budgeted scope of work
- Work is performed within applicable timelines and according to applicable quality standards
- Provide staff and project oversight at a regional level, even if not directly involved in project or line management of specific staff
• Provide guidance and coaching on complex safety reporting scenarios
• Point of escalation to support staff with complex sponsor requests
• Escalate any issues or concerns related to study or staff conduct
• Maintain knowledge and understanding of safety related regulations and guidelines
- Maintain full understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
- Participate in proposal review and budget process, bid defense meetings, authoring department standard operating procedures
• Organize and provide training sessions
• Participate in staff recruitment and on-boarding
- Participate in business development activities such as presenting at conferences, participating in marketing efforts, authoring white papers, etc.
• Represent PV at sponsor audits as needed
- Provide consultation to clients or potential clients and staff on complex global safety requirements and best pharmacovigilance practices
• Advise and assist PV staff as needed
• Participate in department and company-wide initiatives as needed
• May serve as back-up to senior PV leadership as needed
• Perform other duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
- Excellent understanding of computer technology, and management of relational database systems, including extraction of data.
- Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
- Excellent organization skills and ability to handle multiple competing priorities within tight timelines
- Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities.
- Ability to anticipate needs and follow through on all assigned tasks
- Able to effectively receive and provide constructive feedback without becoming defensive.
- Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame.
- Bachelor’s degree in a science-related field, or nursing, or equivalent
- Minimum of 8 years of global pharmacovigilance experience (pre-approval clinical trials) across a variety of phases and therapeutic areas
- Demonstrated history of strong leadership skills including a minimum of 2 years in a leadership capacity
- Equivalent combination of relevant education and experience
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
- Excellent written and verbal communication skills
- Excellent organization skills and attention to detail
- Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines
- Ability to work independently, prioritize work effectively and work successfully in matrix team environment
- Proven experience in clinical trials with a strong knowledge of SOPs, regulatory reporting requirements and accepted practices
- Strong understanding of the work performed by other functions and how they interact
- Strong understanding of and appreciation of the wider issues affecting the efficiency and running of the department
- Proven ability for working independently with minimal supervision
- Strong interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations
- Confidence in dealing with external and internal clients and providers
- Ability to motivate other team members to achieve project and personal targets
- Proven ability to guide and manage less experienced staff
- Ability and willingness to travel domestically and internationally if needed
- Fluent in written and verbal English