Safety Scientist, Specialist III-FSP

Summarized Purpose : Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to medium in complexity or which concern low to medium complexity products.

Additionally supports mentoring of more junior colleagues and development of processes, tools and systems.

Essential Functions and Other Job Information : Essential Functions 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.

Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Job Knowledge A seasoned, experienced professional with a full understanding of area of specialization;

resolves a wide range of issues in creative ways.

This job is the fully qualified, career-oriented, journey-level position. Supervision Received Normally receives little instruction on day-to-day work, general instructions on new assignments.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Business Relationships Represents the department as a prime contact on projects.

Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.

Networks with senior internal and external personnel in own area of expertise. Qualifications : Education and Experience : 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).

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 and Abilities :

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 Management Role : No management responsibility Working Conditions and Environment : Work is performed in an office environment with exposure to electrical office equipment Daily exposure to high pressure and intense concentration Daily interactions with clients / associates Long, varied hours on occasion Travel required on occasion domestic and / or international Physical Requirements : Frequently stationary for 6-8 hours per day Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists Frequent mobility required Occasional crouching, stooping, bending and twisting of upper body and neck Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf Ability to communicate information and ideas so others will understand;

with the ability to listen to and understand information and ideas presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse groups Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals Requires multiple periods of intense concentration Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence Ability to perform under stress and multi-task Regular and consistent attendance