Facilitates safety data analysis and management by optimizing the quality documentation, data management and assessment of individual case safety reports (ICSRs) from spontaneous adverse drug reactions and serious adverse events from certain Clinical Studies for all client’s pharmaceutical products and devices marketed in the United States, in compliance with federal regulation and SA SOP’s.
Role Responsibilities:
• Collects information on domestic adverse events via phone, e-mail, or fax.
• Summarizes information obtained to facilitate accurate data entry. Prepares a clear and concise narrative of the event.
• Identifies clinically significant information missing from initial reports and facilitates its collection.
• Initiates follow-up correspondence in consultation with medical staff.
• Enters domestic adverse event data (from both spontaneous and clinical trial reports)
• Codes according to controlled vocabularies (currently: MedDRA)
• Searches database to prevent duplicate entries.
• Makes necessary corrections as per regular Quality Control queries.
• Reviews and corrects electronic case reports following entry.
• Reviews all adverse event reports from clinical trials and all spontaneous reports for completeness and consistency.
• Alerts senior managers to potential signals, such as an unusual number of similar reports.
• Demonstrates role specific Competencies on a consistent basis.
• Demonstrates company Values on a consistent basis.
• Performs related duties as requested.
• Participates in case management team meetings and projects.
Management Responsibility:
This position has no direct reports.
This position does not manage a team of people.
This position does not have budgetary responsibility.
Experience:
1+ years experience in the pharmaceutical industry.
Experience in Drug Safety, Pharmacovigilance or Safety Surveillance is preferred.
Strong clinical experience or working with actual patients is preferred.
Experience with MedDRA coding.
Professional Skills:
•Technical/Professional Knowledge – Familiar with adverse event/experience regulations regarding spontaneous and clinical trial reports; Patient interviewing skills learned and demonstrated during clinical rotations or clerkships; Medical terminology, reporting and practice guidelines knowledge.
•Technical/Professional Knowledge – Computer literacy, familiar with data entry conventions and actions (MedDRA, AWARE or other safety databases).
• Communication Skills – Ability to write clearly and concisely to document adverse events and communicate patterns of reports to senior management; Communicates for understanding and results.
• Planning and Organizing – Good organizational skills, knows when to ask for help or delegate tasks.
• Building Working Relationships – Team player respectful.
• Customer Focus – Is attentive to needs of internal and external customers; Has patience and the ability to deal with difficult callers; Is able to handle conflicts as needed.
• Personal Accountability – Is self-motivated and takes a proactive stance regarding work; Demonstrates the ability to create own sense of urgency and to work in high pressure environment.
• Innovation – Demonstrates creativity; remains open to ideas of others.
Education: Bachelor’s Degree. RN or Pharmacist or similarly certified health professional or equivalent health science degree.
Contact: Hari
The best telephone number to reach me is 973-481-0100 Ext: 3051. I appreciate if you forward your updated word formatted resume at /narahari.pulikollumakroscientific.com for review before we speak.
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makroscientific.com for review before we speak. 
