106 applicants

Company

Worldwide Clinical Trials · 2 days ago

Senior Associate, Pharmacovigilance

Durham, NC

Full-time

Remote

Mid, Senior Level

5+ years exp

Maximize your interview chances

Health CarePharmaceutical

Actively Hiring

Insider Connection @Worldwide Clinical Trials

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

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/or 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 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 presentations

May mentor or train new PV staff

Perform other duties as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Pharmacovigilance experienceSafety Database managementMedical terminologyDegree in scienceMS Office proficiencyHandle competing prioritiesFluent in English

Required

Bachelor’s degree in a science-related field, or nursing, or equivalent

Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials)

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

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