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Company

Vera Therapeutics, Inc. · 5 hours ago

Director, Pharmacovigilance Operations

United States

Full-time

Remote

Director/Executive

10+ years exp

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Responsibilities

Ensure standards for collection and processing of ICSRs which include alignment with GDPR requirements.

Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in global PV processes.

Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and monitoring of performance and compliance, and training at a global level.

Liaise with PV Systems team to ensure case processing SOPs and Tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc.

Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs).

Direct relationship with and output of vendor(s) in accordance with SOPs.

Liaises VP of DSPV, financial / project management for budget planning.

Approve invoices and confirm accuracy of spend and bills.

Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor.

Direct planning for ad-hoc case processing related projects (e.g. Legal cases).

Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:

Adherence to KPIs and Vera Standards

Issue escalations

Continuous improvement initiatives

Change management

Manage / review delivery against MSA terms.

Monitor global KPIs.

Ensure quality of deliverables across teams.

Represent voice of vendor to PV function.

Provide guidance to delivery teams.

Maintain operating procedures (describing operating rules with vendor).

Lead change management and ongoing training.

Establish and manage vendor oversight procedures.

Partner with DSPV Compliance and QA teams to establish and manage vendor quality agreement procedures.

Drive preparedness for regulatory authority inspection and internal audits for PV operational activities alongside the VP and ED of Vera DSPV; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation.

Qualification

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Pharmacovigilance (PV)Global PV inspectionsVendor relationship managementMedical/scientific terminologyProject ManagementCross-functional collaborationDecision-making capability

Required

A bachelor’s degree in a health/biomedical or related field, OR Registered Nurse, Licensed Practical Nurse, or Pharmacist with current certification/licensure (e.g., LPN, RN, RPh, PharmD) required.

10+ years of pharmaceutical or health care related industry experience required.

Must have significant PV experience including experience working with CROs, vendors, and relationship management.

Must have experience in Global PV inspections which include serving as an SME with direct contact with inspectors.

Must have experience in preparing written responses from inspection findings, completing CAPA and implementing efficacy checks.

Good cross cultural and cross functional understanding and experience, and ability to liaise with relevant teams/departments such as medical information, regulatory, affiliate relations.

Demonstrated skills in negotiation and consensus decision making.

Demonstrated effectiveness in external partner relationship management.

Understanding of medical/scientific terminology.

Knowledge of PV regulations for global pre- and post-market products.

Good analytical/judgment capabilities to understand/analyze/synthesize and communicate successfully as well as key decision-making capability.

Project Management abilities.

Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives.

Able to manage both time and priority constraints and to manage multiple priorities simultaneously.

Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.