Senior Associate, Global Safety Surveillance

Senior Associate, Global Safety Surveillance
Req#: 51411049




 

At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.


Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



PRIMARY OBJECTIVE:
 
Coordinating and performing the processing, and assisting in the collection and reporting of adverse events data in compliance with applicable FDA and global regulations and Elan Pharmaceuticals' Standard Operating Procedures (SOPs) and guidelines. Performing accurate computer data entry or identified AE information and ensuring the uniform and timely processing of adverse event reports. Coordinating the compilation of global and US aggregate reports. Participating in the set-up and maintenance of adverse event workflow, monitoring department policies and standard operating procedures. Coordinating the department's clerical workflow, and assisting with special projects. Acting as liaison with internal and external business partners to meet global regulatory reporting requirements and support other Elan business areas. Assisting with the preparation of internal and external reports. Operations Management staff are members of cross-functional teams and assist in the work of other GSS groups as needed.

DUTIES/RESPONSIBILITIES:


- Performs data entry of adverse events data into the global safety database.
- Performs the processing of adverse event information received by the GSS department, and assists in the preparation of internal and external reports under supervision.
- Writes case narratives under supervision.
- Assists in the review of adverse event information received by the GSS department for completeness and consistency.
- Participates in the compilation of aggregate reports per US and international regulations under supervision.
- Participates in special projects as assigned.


MINIMUM EDUCATION/EXPERIENCE:


BS in Life Sciences and 1-3 years related experience or MS and 1 year experience.

PREFERRED EDUCATION/EXPERIENCE:


BS in Life Sciences and 3-5 years related experience or MS and 1-3 years experience.

SKILLS/ABILITIES:


- Knowledge of FDA and international adverse event reporting regulations per International Conference of Harmonization (ICH) Guidelines and the ability to interpret and apply applicable regulations to resolve issues.
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with regulations.
- Experience with preparation of investigational and postmarketing regulatory reports.
- Proficiency with standard desktop computing programs, and relational databases.
- Excellent oral and written communication skills.
- Demonstrates consistent attention to detail.
- Highly organized and understanding of workflow prioritization.
- Project management experience is desirable.

 

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