Sr Safety Spec

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you!  We know that meaningful results not only require the right approach, but also the right people.  We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.  Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.As a Senior Safety Specialist you will be responsible for completing and overseeing daily Pharmacovigilance (PVG) activities.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  Summarized Purpose: Performs and may oversee day-to-day Pharmacovigilance (PVG) activities performed 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. Essential Functions:  

• Works independently to perform day-to-day PVG activities. May participate in on-call 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. 
• Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events (AOSE) for both developmental and market-authorized products.  
• Serves as the primary point of contact for low, medium and high complexity literature projects(e.g. high complexity projects with more than 5 products, projects involving review for ICSRs, signal-relevant, aggregate safety report-relevant safety information and/or AOSE, and projects with high volume of citations).
• Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
• Participates in departmental initiatives.
• May prepare for and attend audits, inspections and bid defenses.

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: Comprehensive knowledge and experience of global pharmacovigilance requirements relating to literature surveillance

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 Working Environment:   PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:  Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.  Able to work upright and stationary for typical working hours.   Ability to use and learn standard office equipment and technology with proficiency.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.   May require travel.  (Recruiter will provide more details.)PPD Defining Principles:  - We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -  If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you