Safety Specialist (Client-dedicated)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As a Safety Specialist you will be responsible for performing day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines: collection, monitoring, assessment, evaluation, research and tracking of safety information, data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborating with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. Assisting in the preparation of departmental and project-specific procedures and processes, preparing for and attending audits, kick-off and investigator meetings.

A day in the Life:

• 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.

Education

• 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, 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

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.