Drug Safety Specialist
Share
Job Location:
Taguig - Philippines
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Drug Safety Specialist Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Drug Safety Specialist youll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Your responsibilities will include the collection monitoring assessment evaluation research and tracking of safety information. You will coordinate and perform PV activities such as data entry coding assessment of adverse events case review follow-up tracking of reports and regulatory reporting activities. You will effectively collaborate with various parties such as project team members client contacts investigators adverse event reporters and third-party vendors. You may assist in the preparation of departmental and project-specific procedures and processes and prepare for and attend audits kick-off and investigator meetings.
What Youll Do:
- 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 Requirements:
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable 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
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment
- Daily exposure to high pressure and intense concentration
- Daily interactions with clients/associates
- Long varied hours on occasion
- Travel required on occasion domestic and/or international
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
IC
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
