Pharmacovigilance Manager

Requisition Number: 4325

Position Title: Manager, Pharmacovigilance

External Description:

SUMMARY:  Responsible for providing management level oversight to assigned staff and projects, overseeing the delivery of pharmacovigilance services in accordance with applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:
 

• Provide direct supervision of assigned 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 guidance and coaching to direct reports
• Escalate any issues or concerns related to study or staff conduct
• Maintain knowledge and understanding of safety related regulations and guidelines
• Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
• May participate in proposal review and budget process, bid defence meetings, authoring department standard operating procedures
• Organize and provide training sessions
• Participate in staff recruitment and on-boarding
• May represent PV at sponsor audits 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.

REQUIREMENTS:

• Bachelor’s degree in a science-related field, or nursing, or equivalent
• Minimum of 5 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 mentorship 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
• Good understanding of the work performed by other functions and how they interact
• Understanding of and appreciation of the wider issues affecting the efficiency and running of the department
• Proven ability for working independently with minimal supervision
• Proven experience of good 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 supervise less experienced staff
• Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defences and/or provide support for business development efforts
• Fluent in written and verbal English

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
 
 
The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs

City:

State:

Employment Type: Regular

Community / Marketing Title: Pharmacovigilance Manager

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong:

CountryEEOText_Description: