Director, Safety Science (Patient Safety & Pharmacovigilance)

Overview of Role:

The Director of Safety Science reviews, leads, strategizes and executes on all day-to-day Safety work and deliverables; including, responses to regulatory inquiries, regulatory-required periodic reporting and assessment of safety risks.

Role and Responsibilities:

1. Perform signal management activities (including signal detection) using various tools and programs (e.g., MS Excel, PowerPoint, Tableau, etc.)
2. Work with Pharmacovigilance vendor to generate safety listings from the Safety Database
3. Interact, communicate and collaborate effectively with cross-functional colleagues and development partners in a professional manner
4. Apply medical knowledge to effectively analyze safety data from various sources (e.g., toxicology, pre-clinical, clinical, post-approval, literature, etc.)
5. Prepare presentations and effectively communicate (verbally and in writing) important safety concerns, and risk management evaluations when necessary to various internal stakeholders at the direction of Safety Science Exec. Director, Sr, Director, or VP
6. Manage literature review for investigational products, and eventually for marketed products when necessary
7. Coordinate, and contribute to authoring, review and submission of periodic safety reports (e.g., DSUR, PADER, PBRER reports) and collaborate with subject matter experts/functions to provide necessary periodic report content
8. Responsible for providing, preparing, authoring, or reviewing safety sections/content of regulatory response documents, investigator brochures (IB), referenced safety information (RSI) and RSI justification documents, clinical trial protocols, informed consent forms (ICFs), and clinical report forms (CRFs)
9. Provide and review safety data for or contribute to the creation of regional product labels (package inserts) and company core data sheet (CCDS)
10. Work with Medical Writers and Biometrics team to plan for Tables, Figures and Listings (TFLs) and content to be included in clinical study reports (CSRs) and submission documents (e.g., summary of safety document module 2.7.4). Author and review sections within these documents when required within established delivery timelines.
11. Coordinate the writing of CSR Safety Narratives with Medical Writing Team or Contractor
12. Responsible for providing, preparing, authoring, or reviewing safety sections/content of risk management plans (RMPs)
13. Work with Qualified Person Responsible for Pharmacovigilance (QPPV) officer and office once established, and support creation of the Pharmacovigilance system master file (PSMF)
14. Schedule, host and prepare slides for scheduled and ad-hoc Drug Safety Committee (DSC) meetings
15. Lead/Assist in developing, implementing, and supporting policies, standard operating procedures (SOPs), tools, etc., pertaining to Safety Science activities when needed; and contribute to cross-functional process development when needed
16. Support Pharmacovigilance (PV) audits and inspections by participating in audit preparedness activities and serving as subject matter expert during regulatory inspections in collaboration with team members
17. Ensures global regulatory compliance for all Serious Adverse Events (SAEs), signal management, risk management, and other PV related activities
18. All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

1. MD, PharmD, PhD or MSN required
2. Strong knowledge and understanding of domestic and international safety reporting and pharmacovigilance requirements and signal detection (e.g., FDA and EU regulations, and guidance documents)
3. 8+ years of drug safety experience
4. Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
5. Knowledge of working with a safety database (i.e., Argus) for retrieval of safety information.
6. Experience in oncology drug development highly desirable
7. Strong computer and database skills
8. Attention to detail, accuracy and confidentiality
9. Clear and concise oral and written communication skills
10. Excellent organizational skills
11. Critical thinking, problem solving, ability to work independently
12. Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
13. Communicate effectively and articulate complex ideas in an easily understandable way
14. Prioritize conflicting demands
15. Work in a fast-paced, demanding and collaborative environment