Vici Health Sciences is seeking a licensed Maryland pharmacist to serve as our Pharmacist-in-Charge (PIC) and Nonsterile Compounding Pharmacist as we expand our business to include nonsterile pharmaceutical compounding.
Our current business model focuses on clinical-trial manufacturing. This position offers an opportunity to help establish, register, oversee and grow a new compounding pharmacy operation while maintaining high standards of quality, safety and regulatory compliance.
The position is ideal for a pharmacist seeking one or two consistent shifts per week. We offer flexibility regarding daily start and end times and will work to accommodate the right candidate.
Key ResponsibilitiesPharmacist-in-Charge and Regulatory Responsibilities
- Serve as Vici Health Sciences’ designated Pharmacist-in-Charge and assume responsibility for the professional and compliant operation of the pharmacy.
- Lead the initial registration and permitting of the pharmacy in Maryland.
- Manage pharmacy permit and nonresident pharmacy registration applications in additional states as the business expands.
- Complete and maintain initial applications, renewals, change notifications, inspection records and other documentation required by state boards of pharmacy.
- Obtain or coordinate additional pharmacist licenses or registrations when required for the PIC by individual states.
- Maintain a multistate licensing and regulatory matrix that tracks application requirements, permit numbers, renewal dates, fees, reporting deadlines and PIC obligations.
- Communicate with state boards of pharmacy, regulatory agencies, inspectors and other licensing authorities.
- Maintain pharmacy permits, registrations, controlled-substance registrations and other regulatory authorizations applicable to the pharmacy’s operations.
- Ensure compliance with Maryland pharmacy law, the requirements of other states in which the pharmacy is registered, applicable federal requirements and USP <795> standards for nonsterile compounding.
- Ensure compliance with USP <800> when hazardous drugs are handled or compounded.
- Develop, implement and annually review pharmacy policies, standard operating procedures and quality documentation.
- Serve as the primary pharmacy contact during regulatory inspections, audits and compliance inquiries.
- Maintain inspection readiness and coordinate corrective and preventive actions when deficiencies are identified.
- Monitor changes in state and federal pharmacy regulations and update policies, procedures and operations accordingly.
- Ensure pharmacy personnel maintain all required licenses, registrations, training and competency documentation.
- Oversee the procurement, receipt, storage, security, inventory control, recall and disposition of drugs, chemicals and compounding ingredients.
- Manage DEA registration, controlled-substance security, recordkeeping, inventory reconciliation and reporting if controlled substances are handled.
- Review and investigate medication errors, complaints, adverse events, deviations and compounding discrepancies.
- Maintain required personnel, prescription, compounding, equipment, quality-control and regulatory records.
Pharmacy Software and Reporting Responsibilities
- Manage the implementation, configuration and ongoing administration of the pharmacy management software.
- Maintain prescription-order entry, patient-profile, formulation, inventory, workflow and reporting functions within the pharmacy system.
- Establish and maintain appropriate user access, security roles and data-integrity controls.
- Coordinate software setup, updates, troubleshooting and vendor support.
- Train pharmacy personnel on proper software use and documentation requirements.
- Manage accounts and submissions through applicable regulatory reporting websites and portals.
- Submit required pharmacy, dispensing, controlled-substance and prescription-monitoring reports accurately and on time.
- Maintain access to and manage applicable state board, NABP, DEA, prescription drug monitoring program and other regulatory portals.
- Track successful report submissions, resolve rejected reports and retain confirmation records.
- Ensure pharmacy data is protected, backed up and retrievable in accordance with applicable record-retention requirements.
Nonsterile Compounding Responsibilities
- Directly supervise and verify nonsterile compounding performed by registered pharmacy technicians.
- Review prescriptions or medication orders for completeness, appropriateness and accuracy.
- Perform final verification and authorize the release of compounded preparations.
- Ensure compounded preparations meet applicable identity, strength, quality, purity, stability and potency requirements.
- Verify formulations, calculations, ingredients, lot numbers, expiration dates, beyond-use dates, labels, packaging and storage requirements.
- Develop and maintain master formulation records and compounding records in accordance with USP <795> and applicable law.
- Ensure ingredients and supplies are obtained from approved sources and stored under appropriate conditions.
- Monitor equipment qualification, calibration, maintenance, cleaning and temperature records.
- Establish quality-control procedures for weighing, measuring, mixing, packaging, labeling and releasing compounded preparations.
- Provide or make available appropriate patient or caregiver counseling when compounded preparations are dispensed.
- Support the development and implementation of new compounded products, formulations and workflows.
- Collaborate with management, quality personnel, prescribers, vendors and other stakeholders to support safe and efficient pharmacy operations.
Required Qualifications
- Bachelor of Pharmacy or Doctor of Pharmacy degree from an accredited school of pharmacy.
- Current, active and unrestricted pharmacist license in the State of Maryland.
- Eligible and willing to serve as Pharmacist-in-Charge.
- Availability to work approximately 16 hours per week on Tuesdays and Thursdays.
- Knowledge of USP <795> and applicable nonsterile compounding standards.
- Ability to lead pharmacy permit and registration processes in Maryland and additional states.
- Ability and willingness to obtain additional state pharmacist licenses or registrations when required.
- Proficiency with pharmacy management software, electronic recordkeeping and regulatory reporting portals.
- Strong understanding of pharmacy operations, quality systems and documentation requirements.
- Strong attention to detail and commitment to patient safety and product quality.
- Ability to work accurately and efficiently in a fast-paced environment while managing competing priorities and tight deadlines.
- Strong knowledge of Good Documentation Practices (GDP), including accurate, contemporaneous, complete and traceable recordkeeping.
- High degree of professionalism, resilience and emotional intelligence, with the ability to collaborate effectively with demanding stakeholders and navigate challenging interpersonal situations.
- Ability to supervise pharmacy technicians and provide clear operational guidance.
- Ability to work independently in a regulated, quality-focused environment.
Preferred Qualifications
- Previous nonsterile pharmaceutical compounding experience.
- Previous experience as a Pharmacist-in-Charge, responsible pharmacist or pharmacy manager.
- Experience registering a resident or nonresident pharmacy in multiple states.
- Experience managing pharmacy software implementation or administration.
- Experience submitting data through PDMP, DEA, NABP or state regulatory portals.
- Experience developing pharmacy policies, SOPs and quality systems.
- Experience supporting pharmacy inspections or regulatory audits.
- Familiarity with controlled-substance requirements, DEA recordkeeping and inventory controls.
- Experience in clinical-trial, pharmaceutical-manufacturing or research environments.
Vici Health Sciences offers a flexible and accommodating environment for a pharmacist interested in a consistent part-time leadership opportunity and a key role in developing a new multistate nonsterile compounding pharmacy service.
Pay: $56.71 - $68.29 per hour
Benefits:
Work Location: In person