Senior BPM Manager​

Are you ready to lead with impact in Pharmacovigilance? Join us as a Senior BPM Manager​, fully dedicated to one global pharmaceutical sponsor, and play a key role in ensuring data integrity and regulatory excellence in patient safety.

IT IS A HYBRID ROLE WITH 3 DAYS IN THE CLIENT OFFICE IN WARSAW

This role is accountable for accurate and timely execution, distribution and maintenance of all company Pharmacovigilance Agreements (PVAs) with Business Partners including, but not limited to, safety data exchange agreements and Good Pharmacovigilance Practice (GVP) agreements to ensure compliance with worldwide regulatory requirements and company policies. This role contributes to the developmentand successful implementation of the Business Partner Management (BPM) 1 -3 yearstrategic plan. The incumbent is the main point of contact for company business development bothwithin headquarters and in the affiliates, and is responsible to establish and maintain good businessrelations with company business partners. The timely execution and implementation has a directimpact on company compliance.

• Identify, develop, negotiate, and finalize (or terminate) complex PV Agreements with all relevant business partners in a timely fashion; ensure timely re-negotiation, updating and finalization (or termination) of complex PV Agreements according to company procedures or change in requirements
• Act as liaison to PV functions (PVP, GSS, GMS, Affiliate Management, and QMS) to assess feasibility of proposals from business partners resulting from license agreements, acquisitions, divestitures, or collaborations to ensure ability to comply with obligations as stated in the agreement; distribute finalized PV Agreements with GPV functions to allow compliance to obligations.
• Support QMS in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to GBPM
• Support the supervisor in Training and mentoring of new staff/contractors and other departments ensuring the relevant safety staff have all necessary knowledge and expertise to execute their responsibilities

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• Minimum BA/BS degree. 6+ years’ experience in the Pharmaceutical industry with at least 6 years in Pharmacovigilance.
• Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU regulations.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.