Associate Director, Pharmacovigilance Operations - Crinetics Pharmaceuticals : Job Details

Associate Director, Pharmacovigilance Operations page is loadedAssociate Director, Pharmacovigilance OperationsApply remote type Remote locations Remote time type Full time posted on Posted 3 Days Ago job requisition id JR000469

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The role is responsible for supporting the Senior Director of Pharmacovigilance (PV) Operations with elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database; and Budgets.

This individual will also support and actively contribute to the development or revision of existing PV processes related, but which may not be limited to: Quality, standards, and training.

The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc.
• Support the development or revision of SOPs, work instructions, guidance regarding all functions within PV.
• 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.
• Contribute to the establishment and maintenance of SDEAs and or other pharmacovigilance agreements (i.e., commercial contracts) between Crinetics and business partners or third-party vendors for specific obligations for safety data exchange and reporting.
• Support other PV Quality Management System activities such as compliance, best practices, continuous process improvements, and collaborating with relevant internal departments to maintain inspection readiness (i.e., PSMF).
• Collaborate with Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities (HA).
• Collaborate with Clinical Development and Clinical Operations to improve process for safety reporting, reconciliation of safety data and protocol template development.
• 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.
• Contribute to business integration including safety data migration and integrating new assets or companies into Crinetics PV system.

Education and Experience:

Required:

• Bachelor's degree in healthcare or a BSN/RN degree with a minimum of 12 years pharmacovigilance experience in a pharmaceutical, biotechnology or related environment. An RPh, PharmD, or PhD degree may be considered with 5 years of relevant experience.
• Extensive professional experience in pharmacovigilance post-market and clinical safety.
• Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (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.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range:$156,000-$194,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.