DRUG SAFETY ASSOCIATE
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 preferred
Due 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 Experis 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.
