SUMMARY: Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.
Serves as Lead PV Associate on small to moderate sized studies that are simple to moderate in complexity and scope of work with support from senior staff.
Tasks may include but are not limited to:
With Guidance And Oversight
- Author Safety Management Plan for assigned studies
- Attend internal and client meetings as appropriate
- Attend and present at Investigator Meetings
- Review incoming SAE data for completeness and accuracy
- Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
- Generate queries for missing or unclear information and follow-up with sites for resolution
- Perform QC of SAEs processed by other PV Associates
- Generate regulatory reports and perform safety submissions as needed
- Prepare and submit periodic safety reports as needed
- Maintain knowledge and understanding of safety related regulations and guidelines
- Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
- May assist with bid defenses or other presentations
- May mentor or train new PV staff
- Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other Skills And Abilities
- Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
- Good understanding of computer technology, and management of relational database systems, including extraction of data
- Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
- Excellent organization skills and ability to handle multiple competing priorities within tight timelines
- Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities
- Ability to anticipate needs and follow through on all assigned tasks
- Able to effectively receive and provide constructive feedback without becoming defensive
- Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame
- Handle confidential and sensitive matters with discretion
- Bachelor’s degree in a science-related field, nursing, or equivalent
- Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials)
- Equivalent combination of relevant education and experience
- Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
- Excellent written and verbal communication skills
- Excellent organization skills and attention to detail
- Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.
- Ability to work independently, prioritize work effectively and work successfully in matrix team environment
- Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting)
- Fluent in written and verbal English
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs