Drug Safety Specialist (FSP) - Day Shift
RemotePhilippines
PhilippinesRemoteFull TimeBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Conduct day-to-day Pharmacovigilance activities including data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting. Review cases for quality, consistency, and accuracy; maintain medical understanding of therapeutic areas and disease states; and prepare regulatory safety reports. Collaborate with project teams, investigators, and vendors while assisting with procedure preparation and attending audits and investigator meetings. Participate in on-call duties for 24-hour case intake coverage. Maintain up-to-date knowledge of regulations and practices through review of relevant publications.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience in PV case processing, triage, and/or peer review is required (minimum of 2 years)
- General understanding of pathophysiology and the disease process
- Detailed knowledge of relevant therapeutic areas as required for processing AEs
- 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 work effectively within a team to attain a shared goal
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Must be able to lift 50 lbs
Desired Qualifications
- Master's degree
- PhD
- Experience in regulatory affairs
- Experience in clinical trials
- Experience in data analysis
- Experience in project management
- Experience in quality assurance
- Experience in risk management
- Experience in pharmacovigilance
- Experience in adverse event reporting
- Experience in case review
- Experience in data entry
- Experience in coding
- Experience in assessment
- Experience in evaluation
- Experience in research
- Experience in tracking
- Experience in regulatory reporting
- Experience in coordination
- Experience in implementation
- Experience in presentations
- Experience in metrics
- Experience in budget considerations
- Experience in mentoring
- Experience in cross-functional teams
- Experience in stakeholder management
- Experience in client relations
- Experience with investigators
- Experience with third-party vendors
- Experience in audit preparation
- Experience in kick-off meetings
- Experience in investigator meetings
- Experience in domestic travel
- Experience in international travel
- Experience in high pressure environments
- Experience in intense concentration
- Experience in challenging circumstances
- Experience in positive and professional demeanor
- Experience in shared goals
- Experience in office environment
- Experience with electrical office equipment
- Experience in 24-hr coverage
- Experience in intake of cases from investigative sites
- Experience in regulatory/pharmacovigilance publications
- Experience in information sources
- Experience in current regulations
- Experience in current practices
- Experience in current procedures
- Experience in current proposals
- Experience in medical understanding
- Experience in applicable therapeutic area
- Experience in disease states
- Experience in quality
- Experience in consistency
- Experience in accuracy
- Experience in peer reports
- Experience in departmental procedures
- Experience in project-specific procedures
- Experience in processes
- Experience in clinical trials
- Experience in Endpoint Assessment Committee
- Experience in Data Safety Monitoring Committee
- Experience in client/investigator meetings
- Experience in review of metrics
- Experience in budget considerations
- Experience in less experienced staff
- Experience in collaboration
- Experience in project team members
- Experience in client contacts
- Experience in adverse event reporters
- Experience in third-party vendors
- Experience in preparation
- Experience in attendance
- Experience in audits
- Experience in kick-off
- Experience in investigator meetings
- Experience in operational excellence
- Experience in patient safety
- Experience in Pharmacovigilance (PV) activities
- Experience in highly regulated environment
- Experience in strict timelines
- Experience in collection
- Experience in monitoring
- Experience in assessment
- Experience in evaluation
- Experience in research
- Experience in tracking
- Experience in safety information
- Experience in coordination
- Experience in data entry
- Experience in coding
- Experience in assessment of adverse events
- Experience in case review
- Experience in follow-up
- Experience in tracking of reports
- Experience in regulatory reporting activities
- Experience in various parties
- Experience in project team members
- Experience in client contacts
- Experience in investigators
- Experience in adverse event reporters
- Experience in third-party vendors
- Experience in preparation
- Experience in departmental and project-specific procedures
- Experience in processes
- Experience in preparation
- Experience in attendance
- Experience in audits
- Experience in kick-off
- Experience in investigator meetings
- Experience in domestic and/or international travel
- Experience in high pressure and intense concentration
- Experience in daily interactions with clients/associates
- Experience in long, varied hours on occasion
- Experience in office environment
- Experience with electrical office equipment
- Experience in passion
- Experience in innovation
- Experience in commitment to scientific excellence
- Experience in collaboration
- Experience in development
- Experience in everyday experience
- Experience in contributions
- Experience in making a difference
- Experience in global team
- Experience in Thermo Fisher Scientific
- Experience in world leader in serving science
- Experience in annual revenue of more than $40 billion
- Experience in Mission to enable our customers to make the world healthier, cleaner and safer
- Experience in accelerating life sciences research
- Experience in solving complex analytical challenges
- Experience in increasing productivity in their laboratories
- Experience in improving patient health through diagnostics
- Experience in the development and manufacture of life-changing therapies
- Experience in innovative technologies
- Experience in purchasing convenience
- Experience in pharmaceutical services
- Experience in industry-leading brands
- Experience in Thermo Scientific
- Experience in Applied Biosystems
- Experience in Invitrogen
- Experience in Fisher Scientific
- Experience in Unity Lab Services
- Experience in Patheon
- Experience in PPD
- Experience in reasonable accommodation
- Experience in job application or interview process
- Experience in perform essential job functions
- Experience in receive other benefits and privileges of employment
- Experience in Equal Opportunity Employer
- Experience in All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status
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