Manager, Pharmacovigilance Evaluation and Reporting Scientist

Job description

Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for a Manager, Pharmacovigilance Evaluation and Reporting (PVER) Scientist, to be located in Horsham, PA, Titusville, NJ, High Wycombe, UK, or Raritan, NJ. This is an individual contributor role, not a people manager role.

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 Manager, Pharmacovigilance Evaluation and Reporting Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned products/reports.

Scheduled reports include; PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents.

Principal Responsibilities:
· Daily activities involve; leading strategy development, planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members.
· Have in-depth product knowledge, serve as product point of contact, and will support Safety Management Team deliverables.
· Partner with team members, stakeholders including Medical Safety Officer (MSOs), and a vendor. Function independently and will have expert knowledge of applicable regulations and guidelines.
· Work closely with Therapeutic Area Lead to support the therapeutic area business.
· Strategically plan and ensure timely, quality reports/safety analyses related to core deliverables.
· Lead collaboration with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development and oversee execution.
· Independently perform and/or lead aggregate safety analysis and case level review and write, contribute to, and coordinate the preparation of core safety deliverables.
· Complete and coordinate complex product reports.
· Ensure commitments (e.g., PV Agreements, assessment reports) are met.
· Partner with vendor to develop reports/deliverables.
· Work closely with management to proactively support Therapeutic Area related business.
· Provide enhanced Safety Management Team (SMT) support to enable proactive safety management.
· Act as core member for assigned products.
· Deliver innovative solutions for aggregate safety strategy and analyses and ensure high quality reports.
For the purpose of Training/Meetings/Audits/Inspections:
· Participate in cross-functional training of relevant stakeholders.
· May act as product or process Subject Matter Expert (SME) during audits/inspections.
· Participate or lead department and/or cross-functional initiatives.
Decision-Making and Problem Solving:
· Think strategically with respect to data interpretation and provide innovative solutions.
· Recognize potential issues and or safety issues and escalate to the attention of the line manager or MSO.
· Have the ability to understand nature of adverse drug reactions and complex associations.
· Maintain a high level of flexibility, multi-tasking, and ability to (re)prioritize work of oneself and others. Have attention to detail and ability to analyze data in broader context.
· Ability to work across multiple functions and therapeutic areas.
· Review regulatory assessor comments/requests and accommodate/address as appropriate.
This position reports into the Pharmacovigilance Evaluation and Reporting Director, Therapeutic Area Lead.

Desired profile

Qualifications :

·  A minimum of a Bachelor's Degree in Health or Biomedical Science with 9+ years of industry experience or equivalent OR an Advanced Degree in Health or Biomedical Science with 6+ years industry experience or equivalent is required.
·  A minimum of 3+ years of Clinical/Medical writing or PV experience required.
·  Fluent English verbal and written communication skills are required.
·  High proficiency in the analysis of large and/or complex aggregate data sets is required.
·  Ability to develop in-depth knowledge of assigned products is required.
·  Knowledge of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines) is required.
·  Knowledge and experience in more than one therapeutic area is preferred.
·  Ability to effectively present to cross-functional teams is required.
Travel will be minimal.

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