Safety Risk Lead-Clinical Medical Affairs (482811)
New York, NY
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an outstanding contract opportunity for a Safety Risk Lead-Clinical Medical Affairs for our client in New York, NY.
The Safety Risk Lead (SRL) will work within Safety Surveillance and Risk Management (SSRM) and function as the Product Safety Management Team Lead (i.e. Risk Management Committee Chairs and Asset Product Team Safety Representatives) flexibly supporting all Business Units (BU)/Research Units (RU)s.
The SRL will perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection evaluation, risk assessment and safety risk minimization. The SRL will also act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters for WSS/WSRO.
This individual will collaborate closely with the relevant WSS VP Safety Strategy Business Unit/Research Unit Leads to support the appropriate BU safety strategies. The SRL obtains guidance from the relevant WSS VP Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.
Other Duties include:
- Providing and accumulating DA specific Pharmacovigilance expertise, and applying this to various BU products assigned to the SRL operating from a SSRM DA Cluster. Each SSRM DA Cluster functions as a Centre of Excellence.
- Performing 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 WSS/WSRO and elsewhere (e.g. clinical, epidemiology, spontaneous, literature regulatory cases, and other scientific data).
- Ensuring 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 (i.e. providing medical content/B R statements and overall risk messaging of the safety profile to WSRO Authors.
- Performing ad hoc special scholarly SSRM activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issues, white papers/product, and due diligence assessments.
- Identifying opportunities for consistency and standards for SSRM approaches and processes within a DA Cluster and across BUs, and supporting the piloting and implementation of such.
- Innovating, championing and implementing Novel Approaches to SSRM across business units.
- Engaging in continuous Improvement initiatives, Safety Sciences Research Communications activities, including methodological improvements.
- Serving as a platform for additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, etc.)
Qualified candidates must hold an MD degree (international degrees accepted) and have expertise in Pharmacovigilance and drug safety.
This position will require some travel between New York City and Collegeville, PA.
If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.
Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.
Kelly Services is an Equal Opportunity Employer.