Senior/Principal Drug Safety Specialist

Job Description

Join Us as a Senior/Principal Safety Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Senior Safety Specialist, you'll perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will effectively collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

What You’ll Do

Works independently to perform day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff.

Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.

Reviews cases entered for quality, consistency and accuracy, including review of peer reports.

Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations

Education and Experience Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

Thorough understanding of pathophysiology and the disease process

Strong knowledge of relevant therapeutic areas as required for processing AEs

Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately

Proficient at complex clinical study administration including budget activities and forecasting

Excellent oral and written communication skills including paraphrasing skills

Good command of English and ability to translate information into local language where required

Computer literate with the ability to work within multiple databases

Proficient in Microsoft Office products (including Outlook, Word, and Excel)

Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal