Summarized Purpose
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 not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Optimally collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors.
Key responsibilities:
- Works independently to perform day-to-day PV 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 expert staff. Reviews regulatory/pharmacovigilance publications and information sources t
- 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.
Keys to Success
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).
Knowledge, Skills and Abilities
- Thorough understanding of pathophysiology and the disease process
- Solid understanding of relevant therapeutic areas as the need arises for processing AEs
- Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately
- Proficient at sophisticated 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 exciting circumstances
- Ability to work effectively within a team to attain a shared goal
Physical Conditions/Work Enviornment
Thermo Fisher Scientific 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.)