Clinical Quality Safety Leader Jobs (NOW HIRING)

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Development of processes and identify and qualify new business opportunities. This role links closely with R&D to leverage technical possibilities and understand technical trade-offs vis a vis market potential. Works closely with market research group to Client new consumer/ patient insights. As initiatives advance toward market launch, this role will also support the development of the winning consumer & ECP big idea, and lead concept, claims, key benefit and RTB visuals, as well as any relevant sights & sounds cues. It is crucial the candidate has global experience as well as innovation, new product development, and/or new product launch experience. This individual must be proficient in market landscape assessment, analyzing diverse market segments and providing recommendations on new market opportunities. This position also supports Client&L in the scouting and due diligence processes with market assessment, conception and financial calculations.

1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.

2. Accountable for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post marketing data, and other sources.

3. Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.

4. Leads Safety Management Team.

5. Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.

6. Accountable for responses to inquiries from regulatory authorities or health care professionals on safety issues. Accountable for safety data for health authority review boards. Accountable for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion. Coordinates product-specific activities.

7. Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (i.e. IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc.) required during active development, submission phase and during marketing phase.

8. Review of medical safety input into study protocols (including MRC and OPCE) MAP, RAP and ICF.

9. Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements.

10. Coordinates involvement of external experts (e.g. authors of "white papers," members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.

11. Accountable for presentations on project/product safety issues to internal Client Boards, or expert panels and other meetings.

12. Collaborates productively and manages in a cross-functional matrix team environment (e.g., SMT).

13. Assist in training of new hires (e.g. new BSLs) and mentor/coach direct reports (PVL/PVE) as required.

14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.

15. Serves as and performs activities of Pharmacovigilance Leader such as ad-hoc medical case review as needed.

Skills:

Three years medical experience postdoctoral

o At least five years in industry or health authority or CRO (of which two years in a global position), including a minimum of three years in drug safety

o Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports

o Experience in leading cross-functional, multi-cultural teams

o Experience in preparing RMPs, PSURs, submission dossiers (SCS)

MD Required

Thanks

Richha Saini

Technical Recruiter

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3439 | Fax: 973.998.2599

"2014 Service Excellence Award Winner from J&J"