Jobs and Careers
PA
Sr. Manager, Pharmacovigilance
Pacira BioSciences, Inc.Parsippany, United Statesfull_timeVerifiedPosted 3 Dec 2024
About the role
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 Sr. 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 7 years relevant pharmaceutical industry or related experience required, with at least 3 directly in pharmacovigilance/drug safety. Functional management experience preferred. <
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s