About PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us?Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary:The Manager, Pharmacovigilance is responsible for supporting all pharmacovigilance (PV) activities for the company, including the management and support of PV vendors and business partners, PV compliance monitoring, PV procedural documents (e.g. SOPs, Work Instructions), and assist in coordination of training on handling of safety related information for Pacira employees, consultants, contractors, vendors, and partners. This individual will work closely with internal cross-function teams, external vendors, and partners to ensure appropriate coordination, management, and communication of safety related information. This individual will be responsible for supporting internal safety review meetings (e.g., Safety Management Teams, Executive Safety Committee, Adjudication Committee).Essential Duties & Responsibilities:
- Support the Director and Head of PV in the management and maintenance of Pacira pharmacovigilance operational, compliance, and scientific activities
- Manage and support PV vendor and business partners, including development of PV agreements, vendor contracts, consulting agreement etc.
- Support and maintain compliance monitoring systems for PV activities including individual case safety reports (ICSRs), aggregate reports (PADER, PBRER, PSUR, IND), risk management plans, signal detection, and other PV regulatory commitments, ensuring appropriate corrective and preventative actions (CAPAs) are in place
- Serve as the deputy PV contact person for audits and inspections of the pharmacovigilance system, ensure inspection readiness and collaborate with Quality Assurance (QA) on risk-based audit schedules
- Manage creation and periodic review of PV procedural documents (SOP, Working Practice) to determine the need for amendments and updates
- Develop training materials and support the training of Pacira headquarters and field staff, vendors, contractors, consultants, and business partners on PV related and safety information handling responsibilities
- Serve as PV liaison to Medical Information and Health Sciences for training on adverse event reporting, adverse event handling in commercial programs, and medical information responses involving safety information
- Serve as PV liaison to clinical teams for Safety Management Plans, protocols, study start up, clinical study reports, informed consent, review of study documents, SAE reconciliation
- Serve as PV liaison to Regulatory Affairs on health authority responses and submissions involving safety information
- Support cross-functional Safety Management Team and Executive Safety Committee and other safety related meetings as required
- Must have global pharmacovigilance experience with products in development and post marketing
- Experience with drug, device and combination products preferred
- Experience with anesthesia/analgesia therapeutic area preferred
- Registered nurse, pharmacist, physician assistant, MD/DO or biomedical degree (g., BS/BA, MS, PharmD or PhD in relevant scientific discipline). Advanced degree preferred.
- At least 5 years relevant pharmaceutical industry or related experience required, with at least 3 directly in pharmacovigilance/drug safety. Functional management experience preferred.
- Advanced knowledge of pharmacovigilance operations, science, and regulations, including knowledge of US, ICH, and EU PV regulations
- Knowledge of MedDRA and WHO drug dictionaries
- Knowledge of drug development process, including experience with safety information handling for drug, device and combination products in clinical trials and post marketing
- Experience with review and interpretation of product labeling information (IB, USPI, SmPC)
- Experience with medical literature review
- Experience with managing vendors and business partners
- Experience working with safety databases (SafetyEasy preferred) and preparation, review, QC and reporting of individual case safety reports and aggregate reports
- Experience with quality systems, establishing and tracking performance metrics, compliance monitoring, and development and maintenance of procedural documents and training programs
- Experience with SDEA/PV agreements and other contractual documents containing information on handling of safety information
- Experience in working with global, cross-functional, multi-cultural teams
- Highly organized and demonstrates consistent attention to detail and quality
- Strong verbal and written communication skills
- Strong interpersonal skills, sound judgment, training experience, and problem-solving abilities
- Competency with MS Office Suite products (Word, Excel, PowerPoint)
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave