Responsible for PV activities which may include but is not limited to:
local PV processes and activities in collaboration with internal functional areas and external parties, PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness and corrective action activities, authoring local SOPs, conducting local training, local literature screening and assessment, ensuring the implementation of risk minimization measures and additional risk minimization measures, support local implementation of applicable business continuity plans, and archiving/ filings and is able to perform these tasks with mínimal supervision.
**Education**:
- Health, life science, or medical science degree or equivalent by education/experience
**Qualification**:
- Have a minimum 1 year of industry experience in pharmacovigilance
- General knowledge of AE reporting requirements and relevant PV regulations
- Must be fluent in English (written and spoken) while proficient in local language
- Strong communications, organizational, and time management skills
- Ability to work in partnership with others (internally and externally) to accomplish quality goals
- Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.
- Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
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**Employee Status**:
Temporary (Fixed Term)
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R227831
