Director of Pharmacovigilance - United States
Want to know company name or location? Company managed [?]
Director of Pharmacovigilance
Avadel, a publicly traded specialty global pharmaceutical company with commercial offices located in Chesterfield, MO is seeking a Director of Pharmacovigilance. The Director of Pharmacovigilance will be responsible for the further development of our pharmacovigilance (PV) system to ensure patient safety, full regulatory compliance, and timely flow of drug safety information to clinical teams and senior management.
The Director of Pharmacovigilance will report to the Senior Vice President of Quality and Regulatory Affairs and will be based in the Chesterfield, MO office. This position will work with many internal departments including Regulatory, Quality, Supply Chain and Sales/Marketing. The external relationships include the company’s pharmacovigilance partner, third party logistics vendor and professional associations.
- Manages pharmacovigilance activities in partnership with external PV partner. Recognizes and escalates significant issues relating to compliance, budgets, timelines or other issues that jeopardize business objectives
- Completes ongoing centralization and standardization of PV activities. Develops standardized methods and processes for evaluating safety data.
- Collaborates with team members on the development and implementation of PV procedures and training documents (including SOPs, CAPAs, and third party agreements). Partners with clinical operations, regulatory affairs, clinical research organization (CRO) and data management groups regarding safety data collection and data reconciliation.
- Recommends upgrades to program and project content, process, and timelines. Demonstrates technological expertise and understanding of business needs. Evaluates probability and impact of risk, and develop plans to minimize impact on program objectives.
- Works closely with external partners to provide timely and accurate medical information services.
- Reviews all reports of adverse drug events and requests for medical information and works closely with external PV partner to determine reporting requirements and necessary actions.
- Ensures compliance with health authority regulations in all aspects of PV case processing and reporting; tracks compliance of expedited safety reports in relation with pharmacovigilance vendors.
- Contributes to regulatory responses, Investigator’s Brochure (IBs), Informed Consent forms (ICFs), study protocols, and other documents as required.
- Monitors and reviews signal detection activities performed by external partners, and provides written reports, as appropriate, to Senior Management.
- Develops and implements risk management plans in accordance with regulatory requirements.
- Reviews submissions to ensure procedural compliance and to assess the medical safety content for accuracy.
- Provides strategic or operational input on project teams and interacts with senior management to report project updates.
- Remains informed of all appropriate current health authority regulations and guidance globally.
- Initiates and maintains Safety Data Exchange Agreements with business partners.
- Leads the establishment and implementation of best practices to create efficiencies for the function.
- Advanced healthcare degree, PharmD Degree preferred.
- 7+ years Global pharmacovigilance and safety surveillance experience, or equivalent
- Full knowledge of US regulations and current guidances dealing with medical information practices; experience developing medical information SOPs.
- Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data and to articulate summary information in verbal and written form.
We look forward to talking with you!