myGwork - LGBTQ+ Business Community · 1 day ago

Safety Scientist, Specialist III-FSP

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

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Responsibilities

Serves as a creator/contributor for signal detection and product safety scientist tasks which are low to medium in complexity or which concern low to medium complexity products.

Serves as a creator/contributor for signal detection and product safety scientist tasks which are high in complexity or which concern high complexity products, under supervision by a more experienced team member.

Conducts quality review for signal detection and product safety scientist tasks which are low to medium in complexity or which concern low to medium complexity products.

Supports training and mentoring of junior colleagues.

Contributes to development of processes, tools and systems.

Participates in bid defense activities.

Works within multiple company and client systems.

Interacts with project team members and clients.

Enables that tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.

Participates in departmental initiatives.

Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.

Qualification

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Pharmacovigilance requirementsData interpretationMedical-scientific writingProject managementMentoringMicrosoft Office

Required

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 5+ years)

Strong knowledge and experience of EU and US pharmacovigilance requirements relating to marketed products

Excellent attention to detail; strong data interpretation and medical-scientific writing skills

Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Good project management skills including knowledge of project administration such as budget activities and forecasting for smaller projects

Ability to mentor less experienced staff and to routinely display best practices; strong advocate of quality and timeliness

Excellent oral and written English language communication skills, including paraphrasing skills

Strong computer skills with the ability to work within multiple systems; proficient in use of Microsoft Office products (including Outlook, Word, and Excel)

Ability to maintain a positive and professional demeanor in challenging circumstances and to address potential friction points or hurdles proactively

Ability to work effectively within a team to attain a shared goal