Associate Medical Safety Director
IQVIA
- card_travel 5 to 8 yrs
- ₹ As per Industry Standards
- location_on South Africa
- Job Applicants: {{jobInsightData.ac}}
- Posted on 14 Sep, 2024
Job Description
We are looking for an Associate Medical Safety Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services.
Role responsibilities include:
- Performing medical review and clarification of trial-related Adverse Events (AEs)
- Reviewing analysis of similar events
- Evaluating post-marketing adverse drug reactions
- Providing medical inputs for signal management and benefit-risk evaluation of drugs
- Reviewing safety aggregate reports
- Reviewing study protocols, investigators brochures, and other safety information
- Reviewing clinical study report narratives
- Providing medical assessment comments
- Serving as an internal consultant for medical support
Associate Medical Safety Director Responsibilities: - Medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions
- Composing, editing, and reviewing Analyses of Similar Events
- Serving as a consultant to pharmacovigilance case processing teams
- Providing aggregate reviews of safety information
- Coding review of medical data listings
- Representing safety and clinical data review findings during client meetings
- Reviewing and editing regulatory reports
- Providing oversight for label development
- Providing medical support at meetings and committees
Requirements: - Medical degree from an accredited and internationally recognized medical school
- Around three years of clinical practice experience and two additional years in the pharmaceutical industry
- Knowledge of federal and local regulations pertaining to clinical research
- Experience in risk management, signal detection, and aggregate reports
- Ability to establish priorities, deadlines, and objectives
- Demonstrated consultation skills
- Ability to maintain effective working relationships
Locations: Centurion, South Africa
- Job Function: Bio Tech/R&D/Scientist
- Industry: Healthcare, Manufacturing/Industrial
- Specialization: Pharmacy
- Qualification:
- MD/ MS (Medicine)
- Any Graduate
- Employment Type: Full Time
Key Skills
- medical safety
- pharmacovigilance
- clinical research
- regulatory compliance
- risk management
- pharmaceutical research
- aes
- clinical data
- case processing
- clinical trials
- life sciences
- clinical study
- medical review
Job Posted by
- Website:
- Industry: Healthcare (Other Healthcare Equipments & Supplies Manufacturing)
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