Pharmacovigilance Associate II

Who we are 

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.  

What Global Pharmacovigilance does at Worldwide Clinical Trials

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.

What a Pharmacovigilance Associate II does at Worldwide

The Associate II is responsible for collecting, processing, evaluating, and reporting incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs), and project-specific instructions.
 
Serves as Lead PV Associate on moderate to large-sized studies that are moderate to complex in the scope of work with moderate support from senior staff.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:
 
With moderate guidance and oversight:

• Author Safety Management Plan for assigned studies
• Attend internal and client meetings as appropriate
• Attend and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and complete applicable tracking of incoming safety information
• Generate queries for missing or unclear information and follow up with sites for resolution
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and perform safety submissions as needed
• Prepare and submit periodic safety reports as needed
• Maintain knowledge and understanding of safety-related regulations and guidelines
• Maintain a basic understanding of the budget and scope of work for assigned projects
• Maintain a basic understanding of the 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 presentations
• May mentor or train new PV staff
• Perform other duties as assigned

 
 
OTHER SKILLS AND ABILITIES:

• Strong understanding of medical and scientific terminology, the principles of clinical assessment of adverse drug events, international regulations, and reporting requirements
• Strong knowledge 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 versus complaining or placing blame

 
REQUIREMENTS:

• Minimum of 3 years of pharmacovigilance experience (pre-approval clinical trials)
• Bachelor’s degree in science-related field, nursing, or 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 a matrix team environment
• Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting, and/or bid defense meeting)
• Fluent in written and verbal English

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