Manager Ii, Pharmacovigilance

2 weeks ago

Irvine, California, United States Tarsus Pharmaceuticals Full time

About the Role
The Manager II, Pharmacovigilance (PV) reports to our Sr Dir, Head of Pharmacovigilance.

This individual will work with the PV team and cross-functional members to implement and maintain Drug Safety and PV regulations into Quality Management Systems and help build and maintain a robust PV compliance system.

This role will also assist with call center scripts development, maintenance, and liaise on reconciliation activities.

Let's talk about some of the key responsibilities of the role:

  • Ensure PV processes are implemented meeting quality and compliance requirements for case management and regulatory submission activities.
  • Implement and maintain Drug Safety and Pharmacovigilance (PV) legislation into Quality Management Systems and contribute to development of standard operating procedures (SOPs) and work instructions (WIs) for quality assurance in DSPV system.
  • Implement corrective and preventive actions (CAPAs), note to files (NTFs) and other deviation documentation to address any identified deficiencies.
  • Ensure and assist audits (internal and external) and inspection readiness, preparation developing audit plans, and maintaining compliance with applicable SOPs, regulations, and guidelines with the Regulatory agencies.
  • Assist in preparation of Aggregate Safety Reports (e.g DSURs, PADERs, PBRERS), review and conduct quality checks (QC) of these documents as needed.
  • Sample and conduct routine quality checks on individual case safety reports (ICSRs) in both clinical and postmarketing settings to ensure compliance with DSPV requirements.
  • Contributes to ongoing safety surveillance efforts for marketed and investigational products via support on surveillance document review, QC, and assist preparation.
  • Act as main strategic liaison between Tarsus call center and internal team members by managing and coordinating communications between different teams to ensure concerns are addressed and necessary changes implemented to improve the call center. Oversees external vendor(s) to ensure any projects or changes are properly implemented in a timely manner. Assists with devising and drafting operational processes that streamline workflows for seamless implementation.
  • Support call center script development, review and update scripts with internal team members and external vendor(s) to ensure alignment with implementation timelines.
  • Support and contribute to Call Center reconciliations and oversight of safety related reports or inquiries.
  • Assist in regulatory agency (RA) or health authority (HA) queries response requests as required. Assist with implementing any followup actions from RA/HA findings.
  • Trains outside vendor(s) to ensure they are up to date with Tarsus regulations and requirements.
  • Maintain up to date knowledge of pharmacovigilance and drug safety related regulations, the regulatory environment, and company SOPs.
  • Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and regulatory compliance of the pharmacovigilance and drug safety system and quality assurance activities.

Factors to Success

  • Bachelor's degree in science or healthcare field or equivalent
  • 57 years of biotech or pharmaceutical industry experience; including a minimum of 35 years in pharmacovigilance and/or pharmaceutical business processes operations
  • Working experience and strong understanding of global pharmacovigilance regulations, FDA/GVP/ICH guidance, and industry best practices including Good Clinical Practices (GCP)
  • Working experience on regulatory agencies inspections and/or internal or thirdparty audits
  • Proficient in ICSR and SUSARs case processing processes, procedures, conventions
  • Excellent communication skills, both written and verbal, with the ability to interact effectively with crossfunctional teams and external vendors.
  • Detailoriented with strong analytical thinking and problemsolving capabilities.
  • Basic experience using excel file for data review and analysis.

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment.
  • Remote work is also an option for this position.
  • This position reports directly to the Sr Dir, Head of Pharmacovigilance.
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LI-Hybrid

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