Roles & Responsibilities:
- Document Management: Draft procedural documents including Standard Operating Procedures, Work Instructions, and Guidance Documents to capture PV processes. Review, format, and route procedural documents authored by other team members.
- Training Support: Assist in developing training materials and curricula for the global PV Team and affiliates. Develop and deliver adverse event reporting training for non-PV internal teams and drug safety vendors on a routine and annual basis.
- Data Management: Perform and compile requests for information (RFI) with PV data, adverse event collection, case processing, signal and risk management, clinical studies, and PV safety concerns.
- Regulatory Correspondence: Manage PADERS submission and publishing for all DRL products. Update PV shared drive with labeling updates and communicate with other PV stakeholders.
- Strategic Information Provision: Ensure provision of strategic information and complete PV Due Diligence for potential product acquisitions/divestitures and create/modify Safety Data Exchange Agreements.
- Compliance: Ensure compliance with executed Pharmacovigilance Safety Data Exchange Agreements (SDEA) and routine reconciliations. Support finance team in processing invoices from safety and risk management program vendors.
- Audit Readiness: Support North America and Global PV team with audits/inspection readiness. Maintain document security and integrity.
- Additional Duties: Perform other relevant tasks as requested by management. Prioritize multiple projects and deliver accurate information within deadlines.
Qualifications:
- Bachelor’s degree in Pharmacy.
- 3-4 years of drug safety experience in the pharmaceutical industry.
- Knowledge of global pharmacovigilance regulations.
- Proficient in MS Office: Word, Excel, & PowerPoint.
- Working knowledge of ICH-GCP guidelines and global PV regulations (FDA, Health Canada, EU).
- Experience in drafting SOPs and preparing training materials.
- Ability to make decisions by applying FDA, HC, ICH-GCP, and GPVP standard regulations/guidance.
Skills & Attributes:
- Technical skills in ICH-GCP and global PV regulations.
- Experience in drafting SOPs and Work Instructions.
- Proficiency in MS Office.
- Ability to prioritize multiple projects and suggest solutions to complex issues.
For more details, please visit our career website.
