Senior Safety Specialist

Job Description

Summarized Purpose: 
Responsible for the overall planning, co-ordination and delivery of pharmacovigilance services for large, complex projects. Oversee and may perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May directly oversee staff and provide input on individual performance.

Essential Functions and Other Job Information: 
Essential Functions:
• Works independently to oversee day-to-day PVG activities. May participate in oncall duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites .
• Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
• Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.

Job Complexity:

Works on complex issues where analysis of situations or data requires an in-depth 
evaluation of variable factors.
Job Knowledge:

Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received:
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Business Relationships:
Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside 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 8+ years).

Knowledge, Skills and Abilities: 
• Excellent understanding of pathophysiology and the disease process
• Expertise in relevant therapeutic areas as required for processing AEs
• Advanced critical thinking and problem solving skills with ability to evaluate and escalate 
appropriately
• Solid project management skills with the ability to manage multiple projects simultaneously
• Ability to motivate, mentor and provide guidance to less experience staff
• Proficient at complex clinical study administration including budget activities and forecasting
• Excellent oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Advanced computer skills with the ability to work within multiple databases
• Advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations
• 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
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

Percent Billable:
80%-100%