Director, Pharmacovigilance - United States
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- Lead cross-departmental activities in support of clinical and postmarketing pharmacovigilance operations activities
- Oversee and manage US and EU clinical and postmarketing pharmacovigilance activities, pharmacovigilance staff, and global pharmacovigilance service provider(s) contracted for supporting clinical and postmarketing pharmacovigilance activities
- Support compliance with US, EU and Rest of World safety reporting requirements
- Interact with company departments including, Commercial Operations, Legal, Medical Affairs, Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, and Project Management
- Represent the Pharmacovigilance Operations department at internal and external meetings
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Key responsibilities include the following:
- Oversee the management of worldwide clinical and postmarketing pharmacovigilance operations activities.
- Oversee pharmacovigilance compliance with regulatory reporting requirements, corporate SOPs, and work instructions including international PV requirements and guidelines
- Oversee generation and quality of safety reports generated from the Argus safety database in support of safety surveillance activities and aggregate safety reports.
- Oversee and/or manage pharmacovigilance operations activities in the preparation of key safety documents for regulatory authorities (e.g. EU RMP, PADER, PSUR, PBRER, periodic listings and safety update reports).
- Acts as a liaison and manages external global pharmacovigilance operations service provider(s) providing pharmacovigilance services
- Develop and/or maintain, review or approve pharmacovigilance related documents including Safety Management Plans, SOPs, Guidelines or work instructions, EU Pharmacovigilance System Master File, signal management plans, training, audit and inspection plans.
- Supports the EU QPPV and collaborates with Affiliates and Rest of World Counterparts as required by pharmacovigilance operations business needs
- Provides pharmacovigilance representation and contributes to safety review committees or other internal committees
- Participates and contributes to activities associated with risk minimization measures (Updates to SmPC, package insert, leaflets, targeted questionnaires etc.)
- Support the development and execution of Pharmacovigilance Agreements and Safety Data Exchange Agreements with vendors, Business Partners and other relevant parties.
- Other duties as assigned
- RN, BSc or higher degree, e.g. MPH, Pharm D., is preferred.
- 10+ years of experience in drug safety/pharmacovigilance
- 3+ years of line management experience
- 5+ years in a pharmaceutical sponsor company is preferred
- Previous experience in Gastroenterology, hepatology or related field, preferred.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of and working experience with FDA postmarketing guidelines and regulations, EU GVP Modules, ICH guidelines, and EMA/CHMP regulations and guidelines, and other international regulatory requirements
- Strong PV operational knowledge including experience with Individual Case safety report handling
- Extensive knowledge and experience with Argus safety database
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Experience with managing pharmacovigilance personnel
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Highly proficient in standard computer software (Word, Excel and Power Point).
- Some travel (<5%/year), in some cases internationally, may be required.