Job Details

Target PR Range: 90-150/hr DOE

Under the supervision of the Senior Director of Pharmacovigilance (PV) Operations, the contract International PV lead will provide guidance to internal and cross-functional teams on regulatory requirements for contractual obligations, ensuring all agreements align with PV system capabilities, quality/compliance standards, and global regulations. This individual will serve as the PV functional lead responsible for the strategic development, implementation, and continuous oversight of pharmacovigilance agreements (PVAs), safety data exchange agreements (SDEAs), and PV contract language. They will ensure that all such agreements are completed with high standards, maintained in compliance with global regulations, and continuously aligned with policies and requirements.

This is a US-based hybrid position.

Position Responsibilities (includes, but is not limited to):

· Ensures that international PV activities are (and remain) compliant with current global PV regulations and standards

· Assists with operationalizing the PV system in new international territories, as needed

· Provides strategic direction to internal and external collaborators for all PVAs, SDEAs, PV contract language, and related processes

· Acts as the primary PV point of contact and responsible person for ensuring that PVAs, SDEAs, and PV contract language is instituted where necessary, and within required timeframes

· Responsible for drafting, reviewing, and negotiating PVAs, SDEAs and PV contract language for applicable activities/contracts in collaboration with vendors, partners and distributors, as required

· Ensures version control of all PVAs, SDEAs and PV contract language, from intake through execution, while confirming that all comments have been resolved with the applicable stakeholder(s)

· Assists in the maintenance and continuous improvement of relevant SOPs, templates, trackers and associated tools that support managing PV contracts

· Collaborates with Legal, Finance, Program Owners, Regulatory, and other internal and external partners/vendors during PV contract negotiations and issue resolution

· Supports and contributes to PV inspection readiness activities, where applicable

Candidate Requirements:

· Bachelor’s degree (preferably in a science or health-related field) and a master’s preferred

· A minimum of 5 years of experience in Pharmacovigilance with strong experience in developing, negotiating, and managing PVAs, SDEAs and PV contract language

· Strong understanding and working knowledge of global PV regulations and guidelines (e.g. FDA, EMA, ICH, MHRA, PMDA)

· Proficient with standard desktop computing programs (e-mail, Word, Excel, PowerPoint) and relational databases

· Excellent Project Management and interpersonal skills, results oriented and strong attention to detail

· Ability to manage multiple, complex projects in a fast-paced environment with capacity to prioritize, plan and organize work assignments under strict timelines

· Strong communication and collaboration skills with internal and cross-functional stakeholders and external partners/vendors

· Ability to work independently, prioritize tasks effectively, and manage competing deadlines

· Dedicated team member with effective decision-making skills within their scope of work, requesting input from others, as needed