Company: Planet Pharma Staffing Limited
Closing Date: 30 Dec 16
Type: Full Time
Salary (£): Competitive
TONI KNIGHT | Recruitment Consultant, EMEA T +44 203868 1009 | M +447398184077 | firstname.lastname@example.org
As a member of the Drug Safety and Pharmacovigilance department, the Drug Safety Associate II, is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable EMA, FDA and global regulations and standard operating procedures and guidelines.
The Drug Safety Associate II will perform accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse eventsto regulatory authorities.
In addition, the Drug Safety Associate II will manage the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other business areas as assigned. Drug Safety and Pharmacovigilance staff are members of cross-functional teams and assist in the work of other groups as needed.
The Drug Safety Associate II may assist in special projects as assigned by Drug Safety and Pharmacovigilance management.
• Registered Nurse or Pharmacist (NB certification is required e.g. RN, RPh, PharmD or
• Health/Biomedical degree (BS, PhD or other related scientific degree/qualification); and 3 to 5 years of pharmaceutical industry experience is required, with experience in pharmaceutical safety related areas.
• Case processing experience is required.
• Knowledge and experience with safety reporting and regulatory compliance, and experience of
international safety reporting/regulations are required.
• Experience in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
• Experience with preparation of investigational and post-marketing regulatory reports
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Experience using or familiarity with ARGUS or other safety database applications
• Experience using or familiarity with MedDRA
• Understanding of medical terminology and ability to summarize medical information
• Excellent oral and written communication skills
• Highly organized and demonstrates consistent attention to detail
• Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
• Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
• Must be quality oriented and demonstrate consistent attention to detail
• Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
• Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment
10 Greycoat Place, London,
|Tel:||+44 203 868 1000|
|Website:||Visit Our Web Site|
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