Kelly Services Safety Surveillance Associate III in San Francisco, California

Safety Surveillance Associate in San Francisco, CA

(12 month W2 contract)

Kelly Services is currently seeking a Safety Surveillance Associate one of our top clients in San Francisco, CA.

As a Safety Surveillance Associate placed with Kelly Services, you will perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection & evaluation, risk assessment and safety risk minimization. SRL in SSRM may be assigned as the product “safety-management-team” (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs but Oncology). SRLs may act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety.

Additional Job Responsibilities:

• The SRL in SSRM may be assigned as the product “safety-management-team” (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs but mainly Oncology. They will collaborate closely with the relevant WWS Safety Strategy Oncology Head to support the BU safety strategies.

o The SRL obtains guidance from the relevant WWS Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.

o The SRL may be assigned to act as a Safety Point of Contact to the Asset Teams, ensuring a unified

communication on safety matters for WSR/WWS.

• The SRL provides and accumulates DA-specific pharmacovigilance expertise, and applies this to various BUs’ products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a “Centre of Excellence”.

• The SRL performs frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available from WWS/WSRO and elsewhere (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data).

• The SRL ensure Consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSR/SER Authors.

• The SRL performs ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.

• The SRL identifies opportunities for Consistency and Standards for SS & RM approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such opportunities.

•The SRL may lead innovating, championing and implementing Novel Approaches to SS & RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.

*5-10 hours/ weeks of travel.

Job Requirements:

• MD (physician)

• DA-specific knowledge is preferred.

5-7 years’ experience

• Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.

• Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.

• Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.

• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.

• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.

• Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.

• Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear.

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

• Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.

Why Kelly?

With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

As a Kelly Services employee, you will have access to numerous perks, including:

· Exposure to a variety of career opportunities as a result of our expansive network of client companies

· Career guides, information and tools to help you successfully position yourself throughout every stage of your career

· Access to more than 3,000 online training courses through our Kelly Learning Center

· Weekly pay and service bonus plans

· Group- rate insurance options available immediately upon hire*

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.

Let Kelly fuel your career—connect with us today.

*Available for purchase and administered by a designated third-party vendor

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm