Safety Specialist

Job Description

Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and 
performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ 
reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings. 

Essential  Functions 
 Performs 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. 
 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. 
 Prepares and maintains regulatory safety reports. 
 Assists with 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. Mentors less experienced staff.

Education and Experience: 
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 2+ 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: 

 General understanding of pathophysiology and the disease process 
 Detailed knowledge of relevant therapeutic areas as required for processing AEs 
 Strong critical thinking and problem solving skills
 Good 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 
 Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel) 
 Understanding 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