Under the direction of the Senior Medical Director, DS&P, the Pharmacovigilance Scientist (PVS) is responsible for assisting / supporting the ongoing aggregate review and analysis of product safety data to support the product life cycle for Purdue products, both pre and post-marketing. Some of those responsibilities include preparation of aggregate safety data reviews for Safety Analyses / Benefit Risk Assessment reports, PADERs (Periodic ADE Reports), PSURs (Periodic Safety Update Reports), and Annual Safety Reports. The PV Scientist will assist in signal evaluations, FDA Waiver requests and the management of responses to regulatory agencies. The PV Scientist will also support DSP activities related to Risk Evaluation and Mitigation Strategy (REMS), Pharmacovigilance Plans, development Risk Management Plans (d-RMPs), and Lifecycle Safety Risk Management (LSRM) / Safety Management Team (SMT). PRINCIPAL ACCOUNTABILITIES: The main responsibility of the PVS, with minimal oversight, will be to efficiently perform various pharmacovigilance tasks in support of DSM / department goals including: * Review and analyze individual case safety reports and aggregate safety data * Preparation, writing of aggregate safety data reviews for Safety Analyses, PADERs, PSURs, NDA Annual Reports, and DSURs (Development Safety Update Reports). * Assist with US signal detection activities via Empirica Signal * Assist in the preparation and presentation of safety data at the Signal Evaluation Group (SEG) meetings. * Actively participate in the Safety Management Team (SMT) meetings. * Support proactive safety surveillance of Purdue products through the planning and execution of pharmacovigilance tasks. * Assist in tracking / evaluating specific safety topics for internal and external stakeholders. * Assist in the review of the scientific literature for relevant safety issues related to Purdue products. * Perform quality control activities for deliverables produced by Drug Safety physicians, as needed. * Support FDA readiness / FDA Inspection activities, as needed. * Review safety sections of clinical trial protocols, safety plans and investigator brochures * Provide responses to ad hoc queries * Creating new, enhancing and maintaining current PV templates, standards and communication tools (e.g. Safety Analysis / BRA template). * Contribute to multi-disciplinary DSP project teams to support continuous improvement.
Doctoral (PhD) level degree in a science or healthcare related field (PharmD may be acceptable).
Required Experience & Technical Requirements
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
- 3 - 5 years relevant pharmaceutical experience (e.g. drug safety, medical research, pharmacoepidemiology) required. Drug safety experience preferred.
- Demonstrated knowledge of, and competence in, application of FDA/GCP/ICH regulations and guidelines.
- Knowledge of basic statistics required.
- Extensive medical / scientific writing, editing, and source document review skills
- Excellent written and verbal communication skills
- Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology)
- Versatility, flexibility, and superior communication skills are essential
- Proficiency with basic MS Office applications (e.g. excel, power point)
- Knowledge of common safety database systems (e.g. Argus) preferred.
- Basic knowledge of MedDRA preferred
- Must have the ability to interact collaboratively and effectively in multi-disciplinary team meetings.
- Must demonstrate accountability for delivery of results and have good decision making skills.
- Must have basic project management skills.
- Must be able to manage own work; prioritize, plan and organize work assignments; and, complete tasks independently.Brief Description/Overview:
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P., a privately held pharmaceutical company founded by physicians, is focused on the needs of patients. Together with its...