To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education/Experience: The ideal candidate will have:
- Bachelor’s degree in life science or equivalent in a medical related qualification for at least 10+ years
- Master’s degree at least 5+ years
- At least 10+ years of experience in working in pharmacovigilance in a pharmaceutical company or a CRO
- Experience in rare diseases is preferred
Knowledge, Skills and Abilities:
- Knowledge of global pharmacovigilance regulatory requirements and guidelines (EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP), 21 CFR 314, for drug/medicinal/biologic.
- An advanced understanding of the drug development process, along with clinical trial methodology, GCP, and medical terminology
- Breadth and depth of experience managing pre-marketing and post-marketing PV
- Ability to apply technical, line, and business knowledge to contribute to the strategic direction of the Pharmacovigilance post marketing and development programs
- Strong communication skills, ability to write and speak effectively; actively listens to others, and provides direct feedback
- Ability to effectively present information and respond to questions from internal and external stakeholders.
- Detailed knowledge and experience using a global drug safety database, e.g. Argus
- Proven experience in project management skills.
- Scientific writing skills
Teamwork and Collaboration
- Ability to develop and leverage constructive relationships across disciplines and functions with a broad variety of people; establishes and maintains professional and productive working relationships with team members
- High level of interpersonal, active listening, and influencing skills; ability to flex these skills in different situations
- Depth of experience in interacting effectively with cross functional study team members
- Outstanding communication (written and verbal), negotiation and leadership skills.
- Effective decision-making skills that include developing innovative options and/or multiple solutions to resolve complex problems
- Ability to define problems, collects data, establishes facts, and draw valid conclusions.
- Ability to analyze and evaluate safety data and make decisions based on the results
- Recommends potential courses of action to management and/or senior leaders that impact safety of patients, both in development and post marketing
- Ability to work independently using knowledge and work experience in ambiguous situations within a work group/ project team/ function. Self-initiates projects.
- Ability to multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
- Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
- Exercises foresight and judgement utilizing comprehensive breadth of knowledge and prior work experience and becomes a resource for others
- Champions innovation to drive business improvement within pharmacovigilance
Work Environment: This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be up to 10% of work time.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 50lbs, less than 25% of the time.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Notice to Recruiters/Placement Agencies:
To protect the interests of all parties, Aeglea BioTherapeutics, Inc. will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Aeglea, including unsolicited resumes sent to an Aeglea's mailing address, fax machine, our geneal inbox/email address, or directly to employees, will be considered Aeglea property. Aeglea will not pay a fee for any placement resulting from the receipt of an unsolicited resume. Aeglea will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Recruiting agencies must obtain advance written approval from Aeglea’s Human Resources department to submit resumes, and then only in conjunction with a valid fully-executed contract for service and in response to a specific job opening. Aeglea will not pay a fee to any Agency that does not have such agreement in place.