Drug Safety Operations Senior - FSP
Drug Safety Operations Senior - FSP
Posted on :
14-04-2025
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1 Vacancy
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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 lifechanging 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. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Location/Division Specific Information
Sydney Australia
Join and be a vital part of our team as a Drug Safety Operations Senior (FSP)and be part of an exceptionally hardworking group dedicated to making a worldclass impact in pharmacovigilance!
Responsibilities
- Support the Pharmacovigilance Country Lead and/or Cluster/Area Lead in maintaining and strictly adhering to the pharmacovigilance system.
- Ensure compliance with all applicable Global pharmacovigilance processes including commercial team engagements PSP MR supplier agreements and issue resolution.
- Assist in the preparation planning and implementation of PV training materials for sales representatives customer service investigators and others.
- Collaborate with the Pharmacovigilance Country Lead and/or Cluster/Area Lead to coordinate vendors ensuring PV activities are completed on time and to the highest quality standards.
- Contribute to the preparation and submission of safety documents.
- Implement global regional and local pharmacovigilance strategies at the LOC.
- Support internal and external pharmacovigilance audits or inspections.
- Establish and maintain oversight of local pharmacovigilance suppliers ensuring effective and seamless communication.
- Maintain and update contact information for local operating company pharmacovigilance personnel for global communications.
Education
- Bachelors degree or equivalent experience in life sciences pharmacy nursing or medical field; advanced degree preferred.
Experience
- At least 2 years of pharmacovigilance working experience in the pharmaceutical or CRO industry with a deep understanding of pharmacovigilance and local regulatory requirements required.
Knowledge Skills Abilities
- Strong understanding of medical/scientific terminology.
- Excellent written and oral communication skills
- Demonstrated ability to work collaboratively with internal and external collaborators.
- Outstanding accuracy attention to detail and the ability to prioritize under pressure.
- Welldeveloped organizational skills and a high standard of computer literacy.
Benefits
Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
- Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits wellness programs and an Employee Assistance Program providing confidential support for personal and workrelated issues.
- Flexibility: Balance your work and personal life with flexible arrangements.
- Extra Leave: Benefit from generous leave policies including the option to purchase additional leave paid birthday leave and company paid parental leave.
- Charitable Giving & Volunteering: Make an impact with paid volunteer time to support nonprofit organizations that matter to you.
- Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning workshops and mentorship programs for continuous learning and skill development.
Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
Join us and contribute to making the world healthier cleaner and safer!
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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