Purpose of the role : This position partners with cross-functional stakeholders in support of the planning,
preparation, authorship, review, and distribution of timely and quality safety deliverables.
- Demonstrates advanced project management skills to drive strategy, development, authorship,review, and distribution of safety deliverables (e.g., aggregate safety reports, assessment reports,medical safety assessments) in accordance with regulatory requirements and procedures in collaboration with cross-functional stakeholders.
- Identifies and manages emerging risks and issues that arise during preparation of safety deliverables (e.g., risk to timeline, new regulatory request impacting the deliverable) and ensures they are mitigated and escalated as appropriate.
- Evaluates, interprets, and synthesizes scientific data and translates it into high quality, accurate safety summaries for inclusion in safety deliverables.
- Drives document quality through execution of quality control measures (i.e., safety deliverable QC,
- Oversight of stakeholder review, and archival of supporting documents).
- Leverages applicable systems, regulations and processes to enable successful, on-time completion of safety deliverables.
- Works and collaborates effectively to build and leverage relationships across functions and organizations to create high quality safety deliverables within specified timeframes.
- Proactively seeks out opportunities to improve overall safety deliverable operational and quality excellence and participates in or leads related process-improvement projects.
- Ensures challenges related to safety deliverable quality, including internal and external feedback, are captured, assessed, and reviewed for improvement.
- Participates in audit and inspection preparation and execution activities.
- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing, Dentistry, Medicine, otherClinical Science)
- Bachelor’s Degree plus 2 years clinical/pharmacovigilance process or safety work experience (required)
- Masters or doctorate, 1-2 years clinical/ pharmacovigilance process or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science) (preferred)
- Excellent written and spoken English
- Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support
- Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable, not required
- Ability to evaluate, interpret and synthesize scientific data and convert it into a quality written summary
- Familiarity with working in a multidisciplinary, matrix team situation while also carrying out responsibilities with minimal direction
- Extremely detail oriented with excellent project management skills
- Effectively manage stressful situations, multiple projects simultaneously and tight project milestone deadlines
Job Type: Experienced