Safety Specialist - FSP Poland
Safety Specialist - FSP Poland
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services as well as postapproval support. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Discover Impactful Work
PPD has been providing comprehensive pharmacovigilance PV) services to the industry for more than 25 years and currently employs over 1300 PV professionals globally. Whilst most of our work to date has been delivered from our multiple hub locations throughout the world we are now
looking to increase the number of smaller spoke locations to help us deliver local (incountry PV services. As a Safety Specialist you will be responsible for performing daytoday PV activities within a highly regulated environment and driven by strict timelines which may include but not be limited to monitoring for collecting translating disseminating and tracking of safety information and serving as a regulatory authority contact point. Your role may also include:
Supporting our global PV operations with activities such as data entry coding and assessment of adverse events followup tracking of reports and regulatory reporting activities.
Effectively collaborating with various parties across the world such as project team members client contacts reporters andthirdpartyvendors.
isting in the preparation of departmental and projectspecific procedures and processes;
preparing for and attending meetings audits and regulatory authority inspections.
This is an excellent opportunity for anyone looking to advance their affiliate PV career whilst gaining exposure to more headquarters PV activities in both the postapproval and clinical trial settings.
A day in the Life
Performs daytoday PV activities as described above. May participate in oncall duties for specific projects to ensure 24hr 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.
ists with routine project implementation and coordination including presentations at client meetings and review of metrics and project budgets.
Mentors less experienced staff
Education
Bachelors 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 somecasesan 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
Strong critical thinking andproblemsolvingskills
Good oral and written communication skills including paraphrasing skills
Good command of English and ability to translate information from/to local language where required; fluency in Polish
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
Due to high volume of applications please note only shortlisted candidates will be contacted.
Thermo Fisher Scientific Inc. values diversity and inclusivity in the workplace. We recognize that diverse perspectives foster innovation and are focused on attracting and retaining individuals who demonstrate strong work behaviors. We are also committed to providing reasonable accommodations for candidates with disabilities. If you require any accommodations during the application process please contact us at.
Join our team at Thermo Fisher Scientific and be part of a company that values integrity intensity innovation and involvement. Apply today and #StartYourStory with us! Visit our website at .
Required Experience:
Unclear Seniority
Employment Type
Full-Time
