The Drug Safety Associate will be responsible for the Initial assessment (triage) and case level review of all serious adverse event (SAEs) and spontaneous reports received in compliance with SOPs and regulatory requirements.
Responsibilities include (but are not limited to) :
- Data entry, case processing and coding in MedDRA of SAEs and adverse events (AEs) for post marketed products and investigational compounds
- Maintain accuracy, consistency and completeness of safety database and/or tracking log
- Assists in the review of legacy data for completeness and consistency as entered into safety database
- Submits or assists with submissions of required reports/documents to Agencies, IRBs, ECs and Investigators on safety issues as required
- Assistance in authoring position statements on key safety issues
- Assists with the AE-SAE reconciliation process
- Draft safety management plan
- Interact with investigational sites and internal clinical teams to provide safety expertise
- Generate queries for the collection of additional information for AEs and SAEs
- Assists with the generation and review of regulatory and ad hoc reports
- Assists with the development of data entry conventions to ensure consistency across database users and products
- Communicate via phone/fax/e-mail with physicians, study coordinators, consumers, caregivers and other parties reporting adverse events to obtain all relevant safety information
- Knowledge, Skills, and Abilities:
- Knowledge of FDA and ICH regulations for drug safety and good clinical practices.
- Ability to evaluate medical and scientific reports and related clinical data
- Excellent oral, written communication and interpersonal skills
- Excellent presentation skills
- Knowledge of database management and use of coding dictionaries (MedDRA and WHO Drug)
- Proficiency in computer programs (Word, PowerPoint, Excel, Access)
- Good organizational skills
- Education and Work Experience:
- RNs, Pharmacists, Physician Assistants or other health care related profession with a minimum of 3 years working within a safety or clinical research department with an advanced degree in a relevant scientific/clinical field preferred.
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