Janssen Research &
Development, a part of the Johnson & Johnson family of companies, is
recruiting for a Drug Safety Associate, Case Processing, Global Medical Safety
Operations to be located in Horsham PA.
At the Janssen Pharmaceutical
Companies of Johnson & Johnson, what matters most is helping people live
full and healthy lives. We focus on treating, curing and preventing some of the
most devastating and complex diseases of our time. And we pursue the most
promising science, wherever it might be found.
Janssen Research &
Development, LLC discovers and develops innovative medical solutions to address
important unmet medical needs in oncology, immunology, neuroscience, infectious
diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives
us. Our patients inspire us. We collaborate with the world for the health of
everyone in it.
The Drug Safety Associate is 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
- 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
- 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
Processes & 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
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.
Perform other related duties as required
- Mentoring of other DSAs or staff, as
- Maintains compliance with company
guidelines and HR Policies
- A degree within the Healthcare profession is required (RN, RPh,
PharmD, BS, PhD, or other related scientific degree/qualification).
- A minimum of 2 years related experience is required
- 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
- Understanding of medical terminology and ability to summarize
medical information is preferred
- Ability to follow guidelines and procedural documents (experience
of working with SOPs etc.) is preferred
- Good verbal and written communication skills
- Familiarity with safety systems is preferred
- Knowledge or experience with Excel, PowerPoint, Visio is preferred
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety Operations
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.