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Crinetics Pharmaceuticals · 1 day ago

Senior Director, Pharmacovigilance Operations

United States

Full-time

Onsite

Director/Executive

$243K/yr - $303K/yr

15+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Senior Director of Pharmacovigilance Operations will oversee pharmacovigilance operations, ensuring compliance, vendor management, and process improvements while collaborating with internal and external stakeholders.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc

Participate in process improvements and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post marketing surveillance

Accountable for business integration including safety data migration and integrating new assets or companies into Crinetics PV system

Accountable for development or revision of SOPs, work instructions, guidance in regard to all functions within PV

Participate in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor; receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements; interface with medical monitors for medical assessment and regulatory classification of SAEs; manage and facilitate SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure

Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements

Accountable for working with relevant internal departments, and actively contributing to, the development of the PSMF

Work closely and collaborate with EU and local Qualified Person (QP) to develop new or maintain pharmacovigilance processes supporting both development and marketed/commercial products

Develop SDEAs or pharmacovigilance agreement with Crinetics partners and vendors for specific obligations for safety data exchange and reporting

Build relationships and collaborate with Clinical Development and Clinical Operations to improve process for safety reporting, reconciliation of safety data and protocol template development

Build relationships, and collaborate with, Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities (HA)

Contribute to inspection readiness and lead HA inspections of Crinetics’ pharmacovigilance function

Responsible for PV budgets, MSA and SOW with PV vendors

May manage, coach and mentor direct reports

Performs other tasks and assignments as needed

Qualification

Pharmacovigilance experienceLeadership in pharmacovigilanceFDAEU regulationsQuality Management SystemVendor managementProcess improvementsAnalytical thinkerCommunicationTime managementInterpersonal skills

Required

Bachelor's degree in healthcare including BSN/RN, RPh, PharmD degree and a minimum of 15 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 5 of which were spent in a leadership role within pharmacovigilance

Extensive professional experience in pharmacovigilance and clinical safety

A proven track record of success in a leadership position within pharmacovigilance

Previous functional management experience, including mentoring and coaching of manager-level pharmacovigilance professionals within your line or as a deployed relationship

Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance

A proven history of successful involvement of driving strategic, global, cross-functional initiatives

A commercial mindset, including an ability to implement new services within an organization and interact with external stakeholders

Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality

Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management and oversight, etc

Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA)

Excellent verbal and written communication and skills

Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

High energy, organized, persistent and creative individual with strong communication and interpersonal skills