Associate Director, Drug Safety Operations
2 weeks ago
**Overview**
The Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner companies to achieve department and company goals.
This position is responsible for supporting Iovance study teams and contributing to the pharmacovigilance activities of all Iovance products. This shall include ensuring the establishment of systems to support safety data collection and integrity and to support high-quality risk benefit assessments.
**Essential Functions and Responsibilities**
- Closely collaborates with various internal stakeholders such as Clinical Operations, Clinical Sciences, Regulatory Affairs, Biostatistics, Data Management, and Project Management, as well as external partners to ensure execution of pharmacovigilance activities in accordance with relevant regulatory requirements.
- Leads or contributes to the development and preparation of periodic safety reports (eg, DSUR and PBRER), responses to safety-related queries from health authorities, investigator communications, and other ad hoc reports as necessary.
- Provides safety review and input into safety sections of clinical documents, including but not limited to investigational brochures, study protocols, informed consent forms, briefing documents, clinical study reports, risk management plans, product labeling, and IND/BLA packages.
- Contributes to signal detection activities, including analysis of individual case safety reports and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all products, to ensure proper identification and evaluation of potential safety signals.
- Participates as a member of the Study Management Team and acts as a safety liaison between the Drug Safety department and key stakeholders in other Iovance functional groups.
- Participates in and supports preparation for inspection readiness activities.
- May prepare or review safety data for presentation in abstracts, posters, or other publications for medical/ scientific meeting and/or congresses.
- Liaises with safety physicians, medical monitors, sites, affiliates, vendors, or other organizations to discuss safety data, as needed.
- Participates in Data and Safety Monitoring Board (DSMB) or independent data monitoring committee (IDMC) meetings for clinical studies, as required.
- Helps select, develop, and train Drug Safety department personnel to ensure the efficient operation of the drug safety function.
- Periodically reviews the scientific literature for new and significant safety findings relevant to Iovance medical products.
- May develop drug safety presentations for investigator meeting.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
**Required Education, Skills, and Knowledge**
- Bachelor’s degree with 10 years of relevant drug safety experience or
- Master’s degree with 8 years of relevant experience or
- PhD or professional qualification in a health science field (eg, RN, PA, NP, or PharmD) and 5 years of relevant experience
- Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
- Strong team player in a multifunctional, multicultural, growing organization.
- Ability to operate objectively and independently as a leader and as a member of a team.
- Must be able to interact effectively with staff of multiple disciplines within and outside the company both nationally and internationally
- Able to lead/supervise activities in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget.
- Ability to take initiative and work collaboratively on multiple projects to achieve goals in compliance with PV and regulatory requirements and agreements with business partners.
- Strong organizational, project management, technical and problem-solving skills.
- Ability to mentor, and coach within PV and cross functionally.
- Excellent oral and written communication and interpersonal skills.
- Experience and extensive working knowledge of MedDRA, safety databases (eg, ARISg, ARGUS, etc.), and Microsoft Office (ie, Word, Excel, PowerPoint, Outlook).
- Experience with transitioning from a pre-market to a marketed product/company environment and knowledge of global requirements desirable.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
**Physical Demands and Activities Required**
- Must be able to remain in a stationary position standing or sitting for prolonged
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