We are seeking a Pharmacovigilance Specialist to work a hybrid role in King of Prussia, PA. The position will be onsite Tuesday and Wednesday each week.
Job Description:
The contractor will serve as the US Deputy Safety Officer (US DSO) under the supervision of the US Local Safety Officer (US LSO). This role involves ensuring compliance with Pharmacovigilance (PV) regulations and Global Safety & Pharmacovigilance (GSPV) policies.
Key Responsibilities:
Organized Data Collection System (ODCS):
Liaise with the US Commercial and/or Global Commercial teams to gather updates on new ODCS programs.
Maintain global ODCS entries involving the USA via HaloPV to comply with PSMF obligations.
Review and provide feedback on questionnaires/surveys for potential safety information elicitation.
Suggest process improvements for HaloPV and manage procedural documents.
Pharmacovigilance Agreements:
Support the implementation of Pharmacovigilance Agreements (PVAs) in collaboration with Global PV Agreements & Alliance (GPAA) and local functions.
Review and comment on PVAs, negotiating terms with 3rd Party Service Providers as needed.
Notify GPAA regarding any PVA terminations, including justification.
Training of 3rd Party Service Providers:
Define and ensure timely completion of PV training requirements for third parties within the territory.
Inspection/Audit Readiness:
Assist the US LSO in maintaining the Inspection Contact List and Roles & Responsibility List.
Manage findings assigned to US LSO/DSO.
Aid 3rd Party Service Providers with audit responses as requested.
Minimum Required Qualifications:
Bachelor's degree in biological, nursing, healthcare, pharmaceutical sciences, quality, or equivalent.
3+ years of experience in the pharmaceutical industry with knowledge of pharmacovigilance.
Understanding of US FDA regulations and international standards related to Pharmacovigilance and Good Clinical Practices.
High proficiency in computer literacy (Microsoft Office, SharePoint, training systems, document management systems, CAPA System).
Strong relationship-building skills with internal and external stakeholders.
Excellent verbal and written communication skills in English.
Ability to work independently and collaboratively in a cross-functional environment.
Competence in managing, resolving, or escalating issues appropriately.
Self-motivated with effective prioritization and planning skills.
Proactive approach to work with demonstrated initiative.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
