Pharmacovigilance Compliance Director

San Francisco, CA, United States
Jan 08, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

The Pharmacovigilance (PV) Compliance Director is a key role and provides expertise and leadership in developing, implementing, and maintaining a robust global compliance program within the Drug Safety Department.

The PV Compliance Director is responsible for ensuring appropriate and applicable training of drug safety staff to ensure compliance with good pharmacovigilance practices, development of metrics, and reporting to senior management across all PV activities including but not limited to: case management and reporting, management of external pharmacovigilance vendors, and lead the action plan and resolution of inspection/audit findings and/or corrective actions; preventative actions (CAPAs). The PV Compliance Director participates in department and cross-functional meetings with regulatory affairs and quality teams, as well as other intra and/or inter-departmental activities and initiatives. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Consistently work with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identify and evaluate fundamental issues for a functional area. May act as a Senior level internal consultant to Senior Management team. Requires in-depth knowledge of the functional area, business strategies, and the company's goals. Assess and develop a robust, global pharmacovigilance compliance program (i.e. Pharmacovigilance audits, vendor audits, PVAs/SDEAs, QEs, Training matrices). Develop key metrics and reporting process for these metrics to senior management. Work closely with all stakeholders in the Drug Safety Department to understand existing processes and procedures, and identify gaps and opportunities for improvement in both effectiveness and efficiency. Partner with members from the Quality Department to align compliance processes and procedures with existing or required quality processes. Develop a professional relationship with existing pharmacovigilance vendors and establish a management and oversight program to assess both the quality and the compliance of deliverables. Maintain excellent knowledge of US/EU and relevant global regulations, ICH and FDA guidelines. Assist with end-to-end case processing activities, as needed, within the ARGUS safety database; writing patient narratives, performing quality checks, querying clinical sites. Participate in both departmental and cross-functional meetings and initiatives to increase the awareness, education, training, and leadership for pharmacovigilance compliance. Identify and support training programs for members of the drug safety department. Develop SOPs and Work Instruction (WI). May have direct reports. Other activities, as needed or as requested by manager.

Minimum of bachelor degree in science; equivalent experience may be accepted. An advanced degree preferred. A minimum of 15 years of related experience, which includes at least 6 years Drug Safety/Pharmacovigilance experience in oncology development programs (post-marketing experience helpful but not required). Experience in Pharmacovigilance quality and compliance, Audit, Gap assessment. Solid medical knowledge and understanding to support safety reporting. Robust and sound knowledge of GCP, GPV, and ICH regulations regarding drug development. Strong knowledge, understanding, and familiarity with ARGUS, with experience in end-to-end case processing for oncology events coming from development program(s). Experienced and demonstrated success in the development and implementation of compliance processes in a pharmacovigilance setting. Ability to multi-task in a high-paced, fast-moving environment with changing priorities. Solid written and oral communication skills. Detail and solution-oriented, able to think outside the conventional "Big Pharma" mentality, and comfortable working in a small company/biotechnology environment.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.