CASY-MSCCN Jobs

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Mandatory requirements:

• At least 5 years of PV experience working as safety physician or equivalent.

• Good experience in ICSR assessment, literature review, signal detection and aggregate report for both Pre-authorization and Post marketing products.

• Trained on Argus or ArisG/LSS safety database.

• Served as therapeutic area lead or support for new business development.

• Involved in any process improvement initiative.

• Participated in client audit or regulatory inspections

• Involved in activities that require interaction with client concerns

Summarised purpose:

• Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR), as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP, Signal detection reports and CSR)

• Serves as the group liaison with other PPD groups and clients.

Essential functions:

• Identifies unusual or significant project related concerns encountered for self or a direct report and proposes strategies for preventing or correcting significant problems.

• Participates in strategy calls, proposal development and bid reviews

• Provides global leadership in medical safety and risk mitigation for specific projects/clients. This may include being the primary PPD medical contact for the client.

• Presents PPD standard medical/safety processes to prospective clients at business development meetings, and communication with medical communities to explore and expand PPD business. This includes participation in business development opportunities (e.g. networking) at educational conferences and meetings.

• Contributes to departmental process improvement initiatives. · Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel

• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.

• Provides medical consultation to team members and answer all project/study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.

• Provides safety reporting training on assigned projects/studies, as requested.

• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.

• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.

• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

• Assists in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

• Manages signal detection activities, scientifically reviews periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities.

• Serves as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters. Creates formal networks with key decision makers.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.