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Senior Associate, Pharmacovigilance (Remote or Office Based)

Employer
Worldwide Clinical Trials
Location
Morrisville, United States
Salary
Competitive
Start date
16 Oct 2019
Closing date
16 Oct 2019

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Job Details

Worldwide Clinical Trials is seeking a Senior Associate, Pharmacovigilance (SAPV) to join our growing team! This position is based out of our offices in Morrisville, NC; however, we are open to more senior-level team members being home-based/remote.

The associate is responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Standard Operating Procedures (SOPs), and project-specific instructions. The drug safety associate independently serves as the Lead drug safety specialist on large-scale studies and programs that are moderate-to-complex in the scope of work. The SAPV also serves in a mentorship/leadership role as requested. 
 
RESPONSIBILITIES:
Tasks may include but are not limited to:
  • Authors Safety Management Plans for assigned studies
  • Attends and presents at investigator, sponsor and team Meetings
  • Reviews incoming SAE data for completeness and accuracy
  • Performs data entry in the Safety Database and/or completes applicable tracking of incoming safety information
  • Generates queries for missing or unclear information and follows-up with sites for clarification/resolution
  • Performs Quality Control of SAEs processed by other team members
  • Generates regulatory reports and performs safety submissions as needed
  • Prepares and submit periodic safety reports as needed
  • Maintains knowledge and understanding of safety-related regulations and guidelines
  • Maintains a basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
  • May assist with bid defenses or other events/presentations
  • Performs other duties as assigned or required
OTHER SKILLS AND ABILITIES:
  • Excellent understanding of medical and scientific terminology; the principles of clinical assessment of adverse drug events; and international regulations and 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
  • Ability to make sound decisions within the scope of responsibility; Focuses on solutions and problem resolution
REQUIREMENTS:
  • Bachelor's degree in a science-related field, or nursing, or equivalent
  • Minimum of 5 years of pharmacovigilance experience (must include pre-approval clinical trials)
  • Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
  • Excellent written, verbal and presentation communication skills
  • High attention to detail
  • Ability to prioritize workload and work independently as well as in a global/matrixed team environment
  • Ability to travel on a limited basis (US and international)

BENEFITS:
  • Worldwide offers a host of benefits tied to local countries and regions across the globe.
EOE:
  • Worldwide offers a host of benefits to include Competitive Salaries; 401(k); Unlimited PTO for Directors and Above; Holidays; Short- and Long-Term Disability; Medical, Dental and Life Insurance; and so much more!

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Description Key Responsibilities Benefits

Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company 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 over 3,000 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.

 

Company info
Website
Mini-site
Worldwide Clinical Trials
Telephone
+44 115 956 7711
Location
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom

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