Specialist 3 - Drug/Product Safety

Drug Safety Associate
POSITION SUMMARY:
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.
PRINCIPAL RESPONSIBILITIES:
75-80%
Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
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
Other activities relating to case processing as appropriate per case, including but not limited to:
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
5%
Processes and procedures: awareness of and input to company procedures and guidance
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
5-10%
Project work: 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
Personal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.
5%
Perform other related duties as required
Mentoring of other DSAs or staff, as identified
Maintains compliance with company guidelines and HR Policies
Key attributes:
Results and Performance Driven (GLP)
Sense of Urgency (GLP)
Big Picture Orientation and Attention to Detail (GLP)
Collaboration and Teaming (GLP)
Integrity and Credo Based Actions (GLP)
Expertise in operational activities including case processing (or other functional expertise).
DECISION-MAKING AND PROBLEM-SOLVING:
Application and knowledge within single case processing context of: GMSO processes and guidelines, regulations and regulatory guidelines, contractual agreements, product-specific information and database/systems functionality
Communication of questions clearly and concisely to the appropriate audience, providing possible solutions where appropriate.
REPORTING RELATIONSHIPS:
This position reports to Manager, Case Processing, Global Medical Safety Operations
WORKING RELATIONSHIPS/INTERFACES:
Global Medical Safety Operations (GMSO) is a functional area within the Global Medical Organization (GMO)
Interfaces
Operational and project related contact with staff in GMSO (all functional groups), Compliance Strategy and Analytics (CSA), Medical Safety Surveillance and Insights (MSSI)
Customer Interfaces
Global Medical Safety/QPPV staff
Operational and project related contact with relevant staff in assigned customer sector (Pharma/Consumer), including e.g. LSOs, clinical and regulatory affairs personnel
Other
Internal and external IT partners
Bio Research Quality and Compliance (BRQC) Partners internal audit and inspection related contact
3rd party partners as required in support of products assigned to team
Global Clinical Organization (GCO)
Medical Affairs
Legal
Office of Consumer Medical Safety (OCMS)
Complaint Vigilance
Global Regulatory Affairs
EDUCATION and EXPERIENCE REQUIREMENTS:
Education:
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 2-4 years experience in pharmaceutical safety-related role
Pharma Experience:
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
Required skills, abilities and competencies include:
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
Positive attitude
Other skills:
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems
Knowledge or experience with Excel, PowerPoint, Visio preferred
RELATED EXPERIENCE:
3 to 5 years