Pharmacovigilance Manager

About Pacira BioSciences, Inc.

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for healthcare 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?

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.

Job Summary:

The Pharmacovigilance Manager is responsible for supporting all pharmacovigilance 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).

Key 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

Requirements:

This position requires a strong background in pharmacovigilance, with experience in managing PV vendors and business partners, compliance monitoring, and procedural documents. The ideal candidate will have a strong understanding of PV regulations, including US, ICH, and EU PV regulations, and experience with safety databases, quality systems, and training programs. Additionally, the candidate should have excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners. The position also requires a high level of organization and attention to detail, with the ability to manage multiple tasks and priorities in a fast-paced environment.

What We Offer:

Pacira BioSciences, Inc. offers a comprehensive benefits package, including medical, prescription, dental, vision coverage, flexible spending account, health savings account, 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, and 401(k) with company match. We also offer flexible time off and 11 paid holidays, as well as paid parental leave. 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.

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