Job Ref: 213345390

Date: 2021-03-11 18:15:56

Apply Now

OVERVIEW:

Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

KEY ACCOUNTABILITIES:

Triage of incoming cases to prioritize for daily workflow management
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
Preparation of SUA summary: Analysis of Similar Events
Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
Completion of all assigned training on company and GMSO procedural documents relating to case processing
Completion of training relating to relevant PV Agreements for assigned products
Participate in designated activities to support revision/creation of case processing procedural documents
participation in assigned projects, including inspection/audit readiness activities
Participation in local or global project teams, including on-time delivery of assigned responsibilities
Participation in inspections and audits as identified, including interviews and provision of requested data
Mentoring of other DSAs or staff, as identified
SKILLS/EXPERIENCE REQUIRED:

Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years experience in pharmaceutical safety-related role
Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
Understanding of medical terminology and ability to summarize medical information
Ability to follow guidelines and procedural documents (experience of working with SOPs etc preferred)
Oriented to quality, attention to detail and accuracy
Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
Ability to work both independently and in collaboration with others
Proactive approach/uses own initiative appropriately
Decision-making and problem-solving skills
Flexibility and adaptability
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems
Knowledge or experience with Excel, PowerPoint, Visio preferredDue to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Jefferson Wells within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set

Apply Now