job title: Safety specialist(thermofisher)

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

Knowledge, Skills and Abilities:

• Min 4+ Years of expereince in PV case processing

• Should have worked in Clinical Trial and PMS cases

• Should have working expereince in Argus Database

• 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