Pharmacovigilance Manager (US/Remote)

Location: North Carolina, United States

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Requisition Number: 3768

Position Title: Manager, Pharmacovigilance

External Description:

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team is made up of a dynamic group of individuals with extensive experience within the Drug Safety world. From watching drugs progress from First in Human administration to global regulatory approval, we are able to be a part of the full lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze and submit to Investigators, Ethics Committees/IRBs and Regulatory Agencies furthering clinical drug development!

The Pharmacovigilance group is the perfect place to launch or further your career. Here you can utilize your medical background, delve into and maximize those investigative skills and learn new skills with opportunities in Project Management as a Safety Lead with oversight of small to large complex programs.

As a Manager, Pharmacovigilance you are 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
  • 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 defense meetings, authoring department standard operating procedures
  • 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.

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 defenses and/or provide support for business development efforts
  • Fluent in written and verbal English

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Pharmacovigilance Manager (US/Remote)

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: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

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© Worldwide Clinical Trials 2021

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.