(Senior) PV Specialist, Affiliate Safety Representative
Share
Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
PRIMARY FUNCTION:
Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVies statutory and ethical responsibilities and complies with local and regional PV regulations for the applicable product portfolio.
Acts as the Affiliates lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PSEQ (Pharmacovigilance and Patient Safety Epidemiology and Research & Development Quality Assurance) function.
MAIN AREAS OF RESPONSIBILITIES:
- Metrics and Oversight of the Pharmacovigilance System
- Quality Management System
- Adverse Event & Periodic Safety Reporting
- Audits and Inspections
- Partnership with business partner with possibility for identification and/or handling of safety information
- PV Training
- Legislation Intelligence
- Risk Management
- Safety Monitoring
- Launch Readiness
- PV Advocacy
- After Hours Availability & Business Continuity
AUTHORITY AND REPORTING LINES:
This position reports into the Affiliate Medical Director.
For all PV-related matters this position has additionally a dotted-line indirect reporting relationship to the EU QPPV
Qualifications :
Qualifications
- Medical pharmacy or life-sciences degree (or equivalent).
- At least two years experience working in the pharmaceutical industry in a pharmacovigilance role is required.
- Excellent written and spoken communication and presentation skills.
- Fluency in written and oral English is essential to facilitate communications with PSEQ Area/Regional Medical and other headquarters functions
- Fluency in written and oral local language a requirement to facilitate communications within the affiliate medical department and with the National Regulatory Agency.
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity
- Sound judgment strong planning and organizational skills and the ability to get things done. Demonstrated strong sense of urgency.
Additional Information :
CRITICAL SUCCESS FACTORS:
- Builds and maintains strong relationships with affiliate colleagues.
- Learns fast grasps the essence ability to manage complexity and changes to change course quickly where indicated to add value to the PV system.
- Acts consistently with AbbVie s ethics obligations and local laws putting patient safety partnerships and overall AbbVies interests before individual immediate team and functional interests.
- Focused on compliance; identifies manages and escalates issues in a timely manner.
- Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk information to area and affiliate stakeholders to positively impact business strategies.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
