Director, DSPV Compliance and Systems

Strategic leader responsible for the development and execution of Drug Safety and Pharmacovigilance (DSPV) processes, systems, trainings and compliance programs for in-development and marketed products. This is a highly cross functional role. Typically works in close collaboration with all sub functions within DSPV, QA, Clinical, legal, commercial and other R&D areas.

Core Responsibilities:

• Ensure business operations excellence through robust oversight of DSPV Quality Management System (QMS)
• Ensure DSPV procedures and processes are established in accordance with the world-wide regulatory requirements.
• Implement PV specific training program for personnel and role-based curriculum.
• Develop and maintain of vendor specific processes and training plans.
• Compliance oversight of ICSRs and aggregate reports to world-wide regulatory bodies.
• Implement and maintain of new systems and associated processes.
• Ensure quality of safety outputs required for ongoing surveillance activities.
• Perform gap assessment of the DSPV QMS on a regular basis. Present feedback and facilitate implementation by collaborating with cross functional teams as applicable.
• Drive DSPV inspection readiness activities and CAPA programs.
• Establish KPIs and KQIs used to determine the effectiveness of the overall PV systems.
• Determine changes to PV regulatory requirements in a timely manner and lead the roll out of such changes to applicable teams.
• Facilitate launch readiness activities across all DSPV functions.

Required Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs.
• Strong knowledge of Argus (similar applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
• Excellent communication and collaboration skills.
• Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet be self-motivated and timeline driven.

Education and Experience:

• Bachelor's degree in healthcare or life sciences- An advanced degree such as RN or BSN, PharmD is preferred.
• Minimum of 10 years Patient Safety/PV of experience with 5+ years of direct experience in pharmacovigilance compliance, standards and systems is required.
• Strong experience in both safety operations and safety sciences is preferred
• Deep knowledge in FDA, EU and ICH guidelines is required.
• Experience with NDA/MAA filing and product launch is preferred.
• People management experience is a plus.

The pay range that the Company reasonably expects to pay for this position is $220,000 - $260,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.