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20 days old

Associate Director PV Scientist

Kelly Services
Summit, NJ 07901
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an **Associate Director PV Scientist** at a prestigious Fortune 500 company working in **Summit, NJ.**


**Job Title: Associate Director PV Scientist**


**Pay: $78.57 per hour**


**Job description:**


Research and Development / Global Regulatory, Safety and Biometrics /

Worldwide Patient Safety/Epidemiology, Safety Science Capabilities and Innovation (ESSCI)

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Supports Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensures pharmacovigilance regulatory compliance.


Mentors less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/subteam needs.


General Product Support

Collaborates with Medical Safety Assessment Physician (MSAP) leading signal detection activities for a products emerging safety profile.

Provides strong medical writing support for PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyzes data for the RSI section of the IB. Collaborates with MSAP to author and analyze data for ad hoc responses to health authorities.

Contributes to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal by Safety Topic Review/ Signal Report.

Analyzes data and prepare documentation to support label updates for assigned products.

Supports Safety for input to regulatory product labeling.

Supports the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.

Applies knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.


Clinical Development & Post Marketing Product Support

Leads core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.

Leads Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Appropriately elevates issues impacting key SMT activities, milestones, and documents to the SMT Chair with limited or no oversight, as needed.

Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.

Provides guidance to junior scientists for reviewing and authoring of safety data/ad hoc queries.

Contributes to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.

Provides input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Safety Topic Review/ Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.

Facilitate the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment. Author the IB RSI table for multiple products with limited or no oversight.

Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with limited or no oversight.


Department Activities

Participates in improvement projects. Assist the PV scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within R&D and WWPS.

Supports preparation for regulatory inspections and audits for evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.

Assists the team and senior management in all forms of issue management and crisis management.

Liaises with all TA staff and maintain an effective and collaborative safety team.

Supports hiring & orientation.


Cross Functional Activities

Supports process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.

Supports the development of strategic plans for safety differentiation of products.

Builds cross functional relationships with SMT membership and stakeholders.


Leadership Behaviors

Proficient

Seek feedback and best practices for continued development

Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.

6 - 8 years relevant Pharmacovigilance/Pharmaceutical Industry experience; Ability to mentor others.

Partners with Medical Safety Assessment Physician (MSAP) to plan, lead, and advance programs.

Good working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.

Good working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.

Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

Ability to work well in cross-functional teams.

Routinely takes initiative

Ability to collaborative and communication skills with scientific subject matter.

Ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.

Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).

Good understanding aspects and methods for data analysis, interpretation and presentation.

Possess good working skills in MS Word, Excel and PowerPoint, including statistics


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-19 Expires: 2021-05-20

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Associate Director PV Scientist

Kelly Services
Summit, NJ 07901

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