Safety Specialist - FSP
Thermo Fisher Scientific
- Toronto, ON
- Permanent
- Full-time
- Supporting our global PV operations with activities such as data entry, coding and assessment of adverse events, follow-up, tracking of reports, and regulatory reporting activities.
- Effectively collaborating with various parties across the world such as project team members, client contacts, reporters, and third-party vendors.
- Assisting in the preparation of departmental and project-specific procedures and processes; preparing for and attending meetings, audits and regulatory authority inspections.
- Performs day-to-day PV activities as described above. May participate in on-call duties for specific projects to ensure 24-hr coverage for calls from regulatory authorities.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
- Reviews cases for quality, consistency, and accuracy, including review of peer reports.
- Prepares and maintains regulatory safety reports.
- Assists with routine project implementation and coordination, including presentations at client meetings, and review of metrics and project budgets.
- Mentors less experienced staff
- 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.
- 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 from/to local language where required
- Computer literate with the ability to work within multiple databases
- Previous exposure to Microsoft Office packages (including Outlook, Teams, Word, Excel and Powerpoint)
- 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