Ampcus, Inc Hiring for Specialist – Drug/Product Safety at Cherry Hill, NJ  Full Time

Description:
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.
Case processing: completion of full case information on the database, including
quality review to ensure accuracy and completeness (75-80%)
* 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 Analysis of Similar Events
* Perform quality review of Individual Case Safety Reports (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 Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) 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: o Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol updates for accuracy
* Vendor oversight activities for assigned products
* Product portfolio subject matter experts
* Operational management activities for onshore teams and vendors, including but not limited to: workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs
Processes & procedures: awareness of and input to company procedures and guidance (5%)
* Completion of all assigned training on company and Global Medical Safety Operation (GMSO) procedural documents relating to case processing
* Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned products
* Participate in designated activities to support revision/creation of case processing procedural documents
Project work: participation in assigned projects, including inspection/audit readiness activities (50-10%)
* 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.
Perform other related duties as required (5%)
* Mentoring of other Drug Safety Associates (DSAs) or staff, as identified
* Maintains compliance with company guidelines and Human Resources (HR) Policies

Key attributes:
* Results & Performance Driven (GLP)
* Sense of Urgency (GLP)
* Big Picture Orientation & Attention to Detail (GLP)
* Collaboration and Teaming (GLP)
* Integrity & Credo Based Actions (GLP)
* Expertise in operational activities including case processing (or other functional expertise).

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.
This position reports to Associate Director, Global Case Processing, Global Drug Safety Operations, GMSO

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 Analytics & Safety Surveillance (MASS)
Customer Interfaces
Global Medical Safety/ Qualified Person for Pharmacovigilance (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)
Product Quality Vigilance
Global Regulatory Affairs

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 Bachelor’s 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 Standard Operating Procedures (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

3-5 years exp

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