Director, Pharmacovigilance
Director, Pharmacovigilance
Senior
Undisclosed
Full Time
Undisclosed
Undisclosed
Undisclosed
Undisclosed
Pharmaceutical
Description

Position Summary: The Director, Pharmacovigilance manages and oversees the company’s drug safety and pharmacovigilance processes, collaborating with cross functional team. The Director will coordinate the development and establish Pharmacovigilance policies in the USA, Europe and other regions, manage their implementation, and ensure standards are established and complied with. Ensures the uniform and timely processing of adverse event reports and submissions to the regulatory authorities. Supports Regulatory Affairs in interactions with regulatory authorities. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements. Oversees the development and preparation of reports for company management as well as external regulatory agencies. Manages and conducts ongoing safety surveillance on company products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary. Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Provide leadership and be a point of contact for all PV-related activities at Aeglea
  • Oversee the development of policies, standard operating procedures (SOP), guidelines for PV
  • Ensure compliance with SOPs, regulatory safety, and PV activities in accordance with national and international regulations
  • Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, and risk management plans
  • Manage the case review of serious adverse event (SAE) reports from clinical studies to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data
  • Ensure the uniform and timely processing and submission of adverse event data, both in clinical trials and post marketing
  • Support the medical monitor(s) of ongoing clinical trials by identifying and evaluating potential safety signals of ongoing clinical trials through the assessment of single case safety reports and aggregate trend analyze
  • Responsible for the strategy for periodic reports and the coordination and writing of these reports such as PADERS, EU PSURs/PBRERS, DSURs
  • Analyze and interpret aggregate safety data and communicate these analyses and interpretation to cross-functional teams
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed
  • Represent PV in submission teams, ensuring consistency and adequacy of safety in submission documents
  • Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing
  • Lead development of Risk Management Plans, implementation and evaluation of their effectiveness
  • Work in collaboration and manage relationships with vendors to ensure appropriate reporting of safety information to regulatory agencies and the prescriber community
  • Coordinate the development of quality oversight and performance indicators in collaboration with the QA department and ensure routine analysis, trending and improvement activities.
  • Support and interact with Health Authorities and/or internal audit programs with respect to audits and regulatory inspections
  • Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
  • Ensure management and oversight of all PV vendor activities
Qualifications

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:

Technical Expertise

  • 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.

 

Decision-making

  • 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

 

Autonomy

  • 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

 

Innovation

  • Champions innovation to drive business improvement within pharmacovigilance

 

Work EnvironmentThis 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 DemandsThe 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.

 

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