Drug Safety Associate II
Company: Planet Pharma Staffing Limited
Closing Date: 22 Dec 16
Salary (£): 30,000 - 40,000
Are you interested in working for a biotechnology company?
Do you have at least 3 years drug safety experience within the UK?
If yes, please read on...
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.
- Processes adverse event information received by the Drug Safety and Pharmacovigilance department (75%-85% Time)
- Reviews case information for appropriate distribution to internal and external business partners
- May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Drug Safety and Pharmacovigilance department management
- Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
- Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes
- Adheres to company templates and guidelines for documentation and communications
- Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database
- Follows company processes and guidelines for case management and closure activities
- Act as a liaison with internal departments and external business partners on Drug Safety and
- Pharmacovigilance operation management issues and clinical study related activities
- May distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
- May distribute reports via EVWeb
- Ensures compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents (5% Time)
- Other duties as required: (15% -25%Time)
- May participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
- May assist in coordinating the department’s workflow and assist with special projects under the direction of the Drug Safety and Pharmacovigilance department management.
- As an individual contributor, may serve as a project manager for functional projects or workflows.
- May mentor DSA I employees
- Participation in Inspections and Audits as identifie
- 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
Please call Sam Chapple at Planet Pharma for more information or email any questions
DD: +44 203 868 8607
Keywords: Pharmaceutical, clinical research, pharmacovigilance, drug safety, PV, Argus, case processing, adverse events, Oxford, Berkshire, Reading, Buckinghamshire, Slough, High wycombe, Maidenhead