Worldwide Clinical Trials · 4 days ago

Associate II, Pharmacovigilance

Durham, NC

Full-time

Remote

Mid Level

3+ years exp

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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

May assist with bid defenses or other presentations

May mentor or train new PV staff

Perform other duties as assigned

Qualification

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Pharmacovigilance experienceDegree in scienceMedical terminology knowledgeClinical assessment principlesInternational regulations knowledgeSafety Database managementMS Office proficiencyFluent in EnglishIndependent work abilityHandle prioritiesProblem-solving focus

Required

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 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