Helping bring new therapies to light
Local Contact Person, Pharmacovigilance – Freelance, PT
Location
Poland
Posted
1 day ago
Salary
0
Seniority
Mid Level
Job Description
Local Contact Person, Pharmacovigilance – Freelance, PT
Allucent
• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required • Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class • Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance • Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed • Performs local literature screening and collection of safety information • Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required • Supports local signal detection, if applicable • Manages locally risk minimization measures, as applicable • Reports to and maintains regular communication with the EU QPPV • Supports the review of local PV agreements, if requested • Performs local PV training to eg. sales force, affiliate personnel, distributors • Provides monthly activity report on status of local PV system
Job Requirements
- University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activities
- Have up-to-date knowledge of applicable global and local regulatory requirements
- In-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are delivered
- Fluency in the written and spoken English language
- Reside in the country where LCPPV provides services, if required
Benefits
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/office-based* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
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