A Drug Safety Executive (also referred to as Pharmacovigilance Officer) in the pharmaceutical industry plays a crucial role in ensuring the safety of pharmaceutical products throughout their lifecycle, from development to post-market surveillance. Their primary responsibility is to monitor, detect, assess, and prevent adverse drug reactions (ADRs) or any other drug-related problems to protect patients and ensure regulatory compliance.
Key Responsibilities:
Adverse Event Monitoring and Reporting:
Collect, analyze, and report adverse drug reactions (ADRs) from clinical trials, healthcare providers, or patients.
Ensure timely reporting of adverse events to regulatory authorities like the FDA (Food and Drug Administration) or EMA (European Medicines Agency).
Risk Management:
Develop and implement Risk Management Plans (RMPs) to minimize the risks associated with pharmaceutical products.
Continuously assess the benefit-risk profile of drugs, ensuring safety protocols are in place.
Signal Detection:
Monitor data for signals indicating new or unknown risks associated with medications.
Perform signal detection through statistical and medical analysis.
Regulatory Compliance:
Ensure compliance with global pharmacovigilance regulations and guidelines.
Manage safety documentation and submissions to regulatory bodies, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
Safety Databases:
Maintain and update safety databases, ensuring that all information on drug safety is accurate and up to date.
Safety Surveillance:
Conduct post-market surveillance to monitor the ongoing safety of a drug after it has been approved for public use.
Review scientific literature and databases for new safety information.
Training and Education:
Provide training to internal teams (R&D, sales, clinical) on drug safety reporting processes.
Educate healthcare professionals about drug safety and reporting procedures.
Required Skills and Qualifications:
Educational Background: A degree in pharmacy, medicine, life sciences, or related fields. Advanced degrees or certifications in pharmacovigilance are highly valued.
Experience: Experience in pharmacovigilance, regulatory affairs, or clinical research is often required, especially for higher-level roles.
Knowledge of Regulations: Deep understanding of global pharmacovigilance regulations (FDA, EMA, ICH, WHO).
Analytical Skills: Ability to analyze large sets of data and identify potential safety issues.
Attention to Detail: Accuracy in reviewing reports and ensuring compliance with safety regulations.
Communication Skills: Ability to convey complex safety information to regulatory bodies and internal teams clearly.
Technology Proficiency: Experience with safety databases and electronic reporting systems (e.g., MedDRA, ARISg, Oracle Argus).
Career Path:
A Drug Safety Executive may start in an entry-level pharmacovigilance role and progress to senior-level positions such as Drug Safety Manager, Pharmacovigilance Director, or Vice President of Safety and Pharmacovigilance.
JOB POSTING:
Job Code: FHS/2024/DS/10
Designation: Drug Safety Executive
Qualification: B Pharm / M Pharm
Experience: 01-03 Years
Model: Work from home
Send Your Resume: hrrecruitment@fidelityhs.com
Do not forget to mention Job Code in email subject/ title.
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