
Global Pharmacovigilance Specialist
1 day ago
The role of a Pharmacovigilance Science Expert is crucial in supporting an international team dedicated to safety surveillance throughout the product lifecycle.
This safety expert performs core pharmacovigilance activities, collaborating with Global Safety Leads/Managers to identify, evaluate, and analyze safety data for both marketed products and those in post-marketing and clinical development stages.
Main Responsibilities:
- Manage ongoing signal detection activities, involving the synthesis of data from multiple sources, including PV databases, literature, and external databases.
- Coordinate and author health hazard evaluations and safety evaluation reports.
- Manage entry and tracking of signals, ME, INR in SMART tool and support GSLs/GSMs with any SMART related activities.
- Review periodic signal detection reports.
- Contribute to responses to Health Authority questions or inquiries from internal or external stakeholders.
- Be a core member of the Safety Management Committee, contributing to produce necessary data outputs and preparing slide presentations.
- Support GSL/GSM to provide safety content for new drug applications and other regulatory filings.
- Collaborate with various stakeholders, including PV Quality, Medical Safety, QPPV, and PV Operations teams.
Required Skills and Qualifications:
- Working knowledge of drug safety and risk management principles.
- 5-8 years of industry experience and understanding of drug development, basic knowledge of regulatory guidelines, and medical coding.
- Stakeholder management, strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
- Excellent organizational and project management abilities, strong communication and interpersonal skills, and ability to work effectively in a cross-functional, multicultural environment.
- Evaluation, interpretation, and synthesis of scientific data, expertise in signal risk management, and proficiency in international regulations and guidelines.
Benefits:
- A challenging role with opportunities for growth and development.
- A collaborative and dynamic work environment.
- The chance to work on cutting-edge projects and contribute to the advancement of pharmacovigilance practices.
Others:
- PREFERRED HEALTHCARE DISCIPLINE DEGREE IN MODERN SCIENCE: MASTER OF PHARMACY, MASTER OF HEALTH SCIENCE, PHYSICIAN ASSISTANT, MBBS, BDS ETC
- Languages: Fluent in English (verbal and written)
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