Manager, Pharmacovigilance
Description
About Pacira
Pacira 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
Supervisory Responsibilities:
This position does not have supervisory responsibilities.
Interaction:
The incumbent works closely with all functional areas and directly with the medical teams, including MHS, Clinical, Regulatory, Medical Affairs, Data Management and Quality.
Education and Experience:
- 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.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- 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)
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The work setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles.
Benefits:
- 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
EEO Statement:
Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.
At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer:
Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.