Job Highlights
Not Disclosed
Posted 8 months ago
Job details
Description
What You Will Do
Key Responsibilities
Managing and coaching of the direct reports if applicable.
Act as a delegate for the Area Safety Head, when required.
Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs
Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable.
Maintain oversight on day-to-day adverse events inbound and outbound reporting as applicable in the given territory.
Responds to safety-related health authority queries in the territory.
Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
Ensure proper identification of local literature articles and for review for AEs and report as required.
Perform regulatory monitoring for impact on vigilance activities and responsibilities
Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.
Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities
Perform document management and archiving as required.
Responsible for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities
Qualifications
What We Are Looking For
Required Qualifications
What You Will Do
Key Responsibilities
- Act as Local Nominated Person (including back-up nominated person)
- Oversight of the PV System & Overall responsibilities
Managing and coaching of the direct reports if applicable.
Act as a delegate for the Area Safety Head, when required.
Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs
Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable.
- Safety Management & Reporting
Maintain oversight on day-to-day adverse events inbound and outbound reporting as applicable in the given territory.
Responds to safety-related health authority queries in the territory.
Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
Ensure proper identification of local literature articles and for review for AEs and report as required.
Perform regulatory monitoring for impact on vigilance activities and responsibilities
Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.
Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities
Perform document management and archiving as required.
Responsible for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities
- Collaboration & Support
- Procedural Document
- Audit & inspection readiness
- PV contract management
- Business Continuity
Qualifications
What We Are Looking For
Required Qualifications
- Education: health care science professional (preferably Physician or Pharmacist).
- 4-6 years of relevant experience.
- Pharmaceutical industry experience including product vigilance responsibility role.
- Ability to organize workflow activities and manage multiple critical issues
- Experience with vendor resource oversight
- Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology
- Expert knowledge of global, regional, and local procedural documents as applicable
- Computer literate with knowledge of relevant IT safety systems
- Excellent verbal and written communication skills
- Ability to establish and maintain open relationships within the organization and with authorities
- Demonstrable knowledge of all local requirements and of global aspects of product safety.
- Fluency in the national language(s) and the English language.
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
- Learning & Development Opportunities
- Employee Resource Groups
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- China
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 16, 2024
Company Overview
上海星颐投资有限公司
Current Openings: 0
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