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Associate Director, Pharmacovigilance Licensing

Lansdale, PA 19446

Posted: 05/19/2023 Job Number: 23945249

Job Description

  • Bachelor's degree is required.
  • A minimum of seven years pharmaceutical experience or relevant professional experience.
  • Deep subject matter expertise in Pharmacovigilance.

Required Skills:
  • Must have proven track record to be able to think critically, strategically, independently and problem solve .
  • Must have a high level of motivation, drive, and demonstration of Client leadership values .
  • Excellent written and verbal communication skills including ability to write clearly and concisely .
  • Top notch interpersonal skills in difficult situations .
  • Driver of change and innovation .
  • Ability to work seamlessly with all levels of personnel .
  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations .
  • Excellent word processing, SharePoint, Excel, e-mail, and online meeting tool skills.

Project Description:
  • Under minimal guidance of the Executive Director - Head of Pharmacovigilance Licensing, the incumbent independently assesses, writes, updates, and maintains pharmacovigilance agreements and safety management plans.
  • This includes exchange of adverse experience data with business partners.
  • Represents Pharmacovigilance Licensing in meetings with internal departments concerning partner agreement reporting responsibilities and process flows.
  • Identifies and prioritizes workload to maintain compliance with departmental and regulatory reporting requirements.
  • This position will report to the Executive Director of PV Licensing within R&D Global Pharmacovigilance (PV) and Safety Science within PV Agreements and Alliance Management in the Research and Development organization.
  • Independently organizes, conducts and/or facilitates meetings with business partners and CRO partners in the negotiation of pharmacovigilance agreements.
  • Independently assesses, writes, updates, maintains, and stores PV agreements according to internal checklists and guidelines as well as company policies and standards.
  • Independently organizes, conducts and/or facilitates meetings with business partners, CRO partners and internal stakeholders for the implementation and maintenance activities in pharmacovigilance agreements.
  • Maintains, in collaboration with the Executive Director - Head of Pharmacovigilance Licensing, the internal guidelines for creating, updating and retention of business partner pharmacovigilance agreements.
  • Responsible for ensuring that the transfer of legacy data to or from the business partner is appropriate and complete.
  • Assesses the requirements and liaises with Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
  • Collaborates with Executive Director - Head of Pharmacovigilance Licensing, to ensure training needs are assessed; creates and implements appropriate training as applicable regarding new processes for each business agreement.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.Com


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Cindi Pisnoy

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