Quality Recruiting. Established Experts.

Manager, Safety Data Exchange Agreement

Reference Number: 3730
Location: NC

Our client is global biopharmaceutical company. They have asked us to assist them in their search for their next Manager of Safety Data Exchange Agreements (SDEA).

Major tasks and responsibilities will include:

  • Acts as the safety contact point on all matters relating to safety agreements with license business partners including the handling of confidential information and the negotiation of agreements with commercial and co-development partners.
  • Coordinates the preparation and conclusion of SDEAs together with relevant internal and external parties.
  • Tracks and maintains oversight on all assigned safety agreements.
  • Communicates contractual obligations to internal stakeholders in a clear and comprehensive manner.
  • Applies standardized contract guidelines in-line with company polices, as well as, legal and regulatory constraints.
  • Ensures oversight and respect of contractual obligations with all internal and external parties for all SDEAs.
  • Ensures compliance with PV regulations, guidelines and industry practice.
  • Actively supports audits and inspections.
  • Escalates issues utilizing governance models and standard communication plans involving business partners.

We seek candidates with the following qualifications:

  • Bachelor's degree required, Master’s Degree preferred.
  • Must have experience with life-cycle of SDEAs (development, implementation and compliance oversight) for an array of business set-ups including manufacturer, Distributor, Supplier, Warehouse, Local MAH (per local legislation) Local Representative (delegation of PV activities), License-Out, License, Co-Development and Divestment.
  • Requires 3-5 years of experience in the pharmaceutical industry, with at least 2 years in Patient Safety.
  • Must have knowledge of the drug development processes and pharmacovigilance obligations
  • Requires experience with global drug safety regulations and working in a global pharmaceutical safety department.
  • Must be proficient in English with excellent reading and writing skills.
  • Requires experience in managing/mentoring junior staff.

If interested, please email your resume as a Word attachment to us, reference 3730.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.