27 days old

Drug Safety - Co-Deputy EU QPPV

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Co-Deputy EU QPPV in Gaithersburg, MD to work a contract assignment of 6 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the** Co-Deputy EU QPPV **includes:**

+ Support execution of EU QPPV responsibilities for Medicinal Products approved in the EU as delegated by the EU QPPV

+ Support Management of EU QPPV ad hoc non-product related responsibilities as delegated by the EU QPPV

+ The position reports to the EU QPPV & Head Pharmacovigilance Excellence

Delegated co-deputy QPPV accountabilities and responsibilities for specified Medicinal Products Authorised or with a Marketing Authorisation Application (MAA) in the EU:

+ Support ensuring the necessary quality, including the correctness and completeness, of Pharmacovigilance (PV) data submitted to the European Medical Agency (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC) and EU national competent authorities.

+ Aware of strategic direction for EU Market Authorisation Applications (MAAs) and substantial EU Life Cycle Management (LCM) submissions in relation to own tasks

+ Aware of any conditions or obligations adopted as part of EU marketing authorizations and other commitments relating to safety or the safe use of the products in relation to own tasks

+ Oversight of the safety profile of Medicinal Products in relation to own tasks

+ Oversight of the risk profile of Medicinal Products including associated risk minimisation measures in relation to own tasks

+ Review, endorse and sign-off of (EU) Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation (PBRERs) and license renewal Addendum to Clinical Overview (ACOs) as assigned

+ Review of Post-Authorisation Safety Studies (PASS) protocols for studies conducted in the EU or pursuant to a RMP agreed in the EU, ready for QPPV sign-off. Aware of the results of PASS and provide input to the interpretation of such results.

+ Support the preparation of, review and endorse responses to ad hoc (non-MAA-related) requests, queries and questions from EU and other Health Authorities (HAs)

+ Support the preparation of, review and endorse Health Hazard Evaluations (HHEs) regarding manufacturing quality issues with potential impact on patients

+ Participate in QC checks of case seriousness assessments

+ Regularly, and as needed, keep the EU QPPV informed about (above-mentioned and other) activities, deliverables and issues in scope of the delegation

Delegated co-Deputy EU QPPV ad hoc non-product related responsibilities:

Could include, but not locked or limited to:

+ Input to and review of elements of the Pharmacovigilance System Master File (PSMF)

+ Input to, review of new and updated Procedural Documents

+ Participation in ad hoc assigned QPPV Office Gatekeeper Operating Model tasks

+ Support continuous improvement projects in scope of the QPPV function to improve processes within Patient Safety

+ Support the EU QPPV in licensing partner audits and local HA inspections

+ Regularly, and as needed, keep the EU QPPV informed about (above-mentioned and other) relevant activities, deliverables and issues in scope of the delegation

General accountabilities:

+ Share best practice in areas of PV, as relevant in relation to own tasks

+ Upon request participate and/or support activities for GVP audits/inspections

Essential Desirable:

+ Medical degree

+ Extensive expert experience in Patient Safety in the pharmaceutical industry

+ Detailed knowledge of relevant PV legislation

+ Insight in current developments in the pharmaceutical industry

+ Excellent communication skills

+ Project management experience

+ PhD in scientific discipline

+ Masters degree or equivalent qualification in relevant life science discipline

+ Expert reputation within the business and industry

+ Extensive knowledge of the latest technical and regulatory expectations in the PV area

Key Relationships to reach solutions:

+ Internal (to company) External (to company)


+ Other members of the QPPV & PV Excellence Team

+ Patient Safety (PS) Product Teams

+ PS Therapeutic Area (TA) Vice Presidents (VPs)

+ Center of Excellence (CoE) VP, other managers and Process Owners (POs)

+ Global Medical Affairs Patient Safety Director, local QPPV and Patient Safety Managers (PSMs)

+ Clinical Development and Regulatory Affairs representatives

+ Business and licensing partners

+ External PV scientific community

**Additional Information:**

+ Contract assignment, duration 6 months.

+ Work schedule: full-time, first shift.

**Kelly Temporary Employee Perks:**

+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts

**Apply Now!**

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Please email your resume directly to Sandy at: [reference BH Job #3047612]

Thank you for your interest in the assignment.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-08-24 Expires: 2020-09-24

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Drug Safety - Co-Deputy EU QPPV

Kelly Services
Gaithersburg, MD 20898

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