Drug Safety Contract Administrator Job in Horsham 19044, Pennsylvania Us

Our Direct Client is looking for a Drug Safety Contract Administrator.

 Location: Horsham, PA.

 6 month contract: + Contract  

Please forward your resume in MS Word format if you are interested with Job# 11-03280 in the subject of your email.

email:   pradeep.darbhe@rcmt.com  

Qualifications:

Minimum of 2 years experience in a drug safety environment is required; pharmacovigilance operational experience is preferred.  Excellent written and verbal communication skills are required. Excellent negotiation and networking skills and demonstrated problem solving ability are preferred.Position will have significant communication with internal stakeholders (Legal, Business Development, EEA, QPPV, Client Functional areas, Regulatory) as well as external 3rd party PV alliance partners.  A minimum of a Bachelors Degree is required.  Knowledge of global PV laws and regulations is required.  Ability to operate in a matrix organization is preferred. 


Here are some of the activities the person would perform.

Support and participate in the Pharmacovigilance Agreements (PVA) and New Business Integration/Divestment process by:

Preparing, negotiating, reviewing and approving pharmacovigilance and/or safety language used in conjunction with Alliance agreements

Drafting pharmacovigilance agreements and amendments from legal department forms

Collaborating across functions including, but not limited to, Client, Client Legal, Business Development, Global Regulatory Affairs, Global Clinical Operations, Quality Assurance and other functional areas to ensure pharmacovigilance responsibilities are adequately addressed in pharmacovigilance agreements.

Communicating with external business clients about pharmacovigilance agreements

Assisting internal business contacts in understanding contract terms and conditions

Negotiating contract terms and conditions with clients and internal functional areas.

Correspondence to internal stakeholders and external business clients

Functioning as first point of contact with business partner and internal functions with respect to pharmacovigilance contract.

Reviewing contract terms and conditions and preparing initial revisions.

Monitor the Alliance; in case of issues take appropriate action and, in collaboration with Director, PAM, determine escalation path, monitor resolution of mutually agreed corrective actions.

Maintain group assignment tracking tool and other tools as necessary

Responsible for managing and tracking due diligence responsibilities for acquisitions, alliances and divestitures on behalf of Global Medical Safety:

Upon request from Pharmaceutical Business Development, participate in Due Diligence efforts; evaluate the pharmacovigilance process and product safety components of global /regional product and/or company licensing and/or acquisition opportunities

Contribute to the relevant sections of Due Diligence Report; i.e. the PV organization; documentation of procedures; information management; case processing; signaling; single case and aggregate reporting; labeling; audits/inspections; and, any program specific issues

Contact appendix updates