Pharmacist, Quality Oversight and Compliance

Pharmacist, Quality Oversight & Compliance

The Pharmacist, Quality Oversight & Compliance will serve as the primary point of contact at the site for complaint management and adverse events related to compounded products and products obtained from third party suppliers/pharmacy partners. The role will be onsite and will report to the pharmacist in charge, and will ensure that complaints are thoroughly reviewed, investigated and reported according to applicable state rules and regulations as well as Federal rules and regulations as well as work with site stakeholders to ensure proper workflow and handling of complaints and adverse events.

You will collaborate closely with cross-functional teams including but not limited to, Compounding operations, Dispense and Fulfill operations, Medical Affairs, R&D, Quality Operations, Post Market Surveillance and Customer Care to help drive investigations and corrective actions as well as continuous quality improvement in an effort to reduce and prevent further quality related complaints. You will assist with BOP and/or FDA inspections and document requests as applicable to the site.

This role requires a hands-on, detail-oriented and highly organized individual with a strong background in pharmaceutical and/or pharmacy customer complaint management, medical escalations/adverse events, and trending of PMS related customer data in order to drive continuous improvement.

You Will:

• Assist in product quality complaints evaluation to determine if it may be an Adverse Drug Event or an Adverse Drug Effect

• Ensure product quality complaints are thoroughly investigated, documented, and communicated in a timely and transparent manner to customers and relevant stakeholders.

• Evaluate product quality complaints, Adverse Drug Events and Adverse Drug Effects to determine reporting requirements

  • Report to appropriate BOP / Agency

  • Report to appropriate team as required

• Assist with product quality complaint investigations, and be a key person to retrieve records from PMS, batch records, cleaning records, as applicable to the investigation

• Patient outreach and counseling as needed

• Answer drug/clinical/stability questions

• Compile investigation closure statement to patients if clinical discrepancies are found in investigation

• Integrate product quality complaint data into CQI reports

• Support return of products to the pharmacy, and assist with investigation and disposal.

• Support data collection and trending of complaints and medical escalations to enhance customer experience and determine potential continuous Improvement opportunities

• Use knowledge and experience as a pharmacist to guide the pharmacy on how best to implement new workflows and product improvements pertaining to customer complaints.

• Work closely with pharmacists onsite to ensure proper handling of complaints and Medical Escalations

• Collaborate on the development and review of SOPs and relevant training.

You Have:

• Doctor of Pharmacy Degree ( Pharm.D)

• Active pharmacist license in the state where the practice site is located. Licensing in multiple states may be required by growing business needs. 2+ years of pharmacist experience

• Effective knowledge of state and federal pharmacy laws, rules and regulations and reporting requirements

• Proficiency in standards including, USP 795, 797, and 800

• Business proficiency in English speaking, presenting, and writing with the ability to engage stakeholders at all levels of the organization and communicate complex issues clearly and concisely.

• Track record of successfully resolving complex issues with structured problem solving approaches.

• Experience managing multiple projects, and tasks simultaneously with effective coordination.

• Demonstrated ability to deliver on-time results

• Excellent analytical skills with the ability to identify trends, perform root cause analysis, and implement corrective actions.

• Willingness to work in a team environment and promote company culture

• Ability to work flexible times.

• Knowledge of customer experience management and the role complaints play in customer retention.

• Experience with customer-facing interactions and the ability to maintain a positive and professional relationship with customers.

Preferred Qualifications:

• 4+ years of pharmacist experience and 2 + years in quality assurance roles in a regulated industry such as pharmaceuticals or compounding facilities.

• Experience in a compounding pharmacy ( 503A or 503B)

• Well versed in Google Suite. Working experience in EMR, Zendesk, pharmacy management system and other complaint management software.

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles

• Unlimited PTO, company holidays, and quarterly mental health days

• Comprehensive health benefits including medical, dental & vision, and parental leave

• Employee Stock Purchase Program (ESPP)

• 401k benefits with employer matching contribution

• Offsite team retreats