AddressJob Description
Job Description
At Thermo Fisher Scientific, you’ll 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 post-approval 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 (in-country) PV services. As a Safety Specialist you will be responsible for performing day-to-day 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, 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.
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 post-approval and clinical trial settings.
A day in the Life:
- 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
Education
- 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.
Knowledge, Skills, Abilities
- 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
