Senior/ Principal Safety Specialist, Bulgaria

Job Description

Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are notlimited 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. 

• Works independently to perform day-to-day PV activities. May participate in oncall duties for specific projects to ensure 24-hr coverage for intake of cases from  investigative sites. 
• Operates in a lead capacity. Provides assistance in the development of program  and departmental procedural documents. May prepare for and attend audits. 
• 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. 
• Reviews cases entered for quality, consistency and accuracy, including review of peer reports. 
• 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. 
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• 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.
• 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.
• 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: 

• Thorough understanding of pathophysiology and the disease process 
• Strong knowledge of relevant therapeutic areas as required for processing AEs 
• Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately 
• 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 
• Computer literate with the ability to work within multiple databases 
• Proficient 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 
• 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 

Management Role: Lead: Provide guidance / mentoring to a small unit or group performing the same or similar tasks where the majority of the time is spent performing the same or directly related individual tasks. Responsible for assigning, reviewing or checking work. May be required to complete tasks of unit members when the need arises. No authority for personnel actions (e.g. salary reviews, promotions, performance reviews, disciplinary actions). 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