Senior Manager, Pharmacovigilance Vendor Oversight Lead

Job Description

About this Role

The Senior Manager, Pharmacovigilance Vendor Oversight Lead, sits within the Safety Surveillance and Aggregate (SSA) reports team and is accountable for managing and oversight (timely, quality standards) the vendors and team members within the unit. This position will regularly engage with multiple vendors in different roles and capabilities – literature, external database mining, signal detection, and aggregate reports. This role with lead functional groups to identify and define optimal business models to support business goals and ensure the operational model meets defined strategic key performance indicators (KPIs) crucial to business success.

The Senior Manager, Pharmacovigilance Vendor Oversight Lead is a global position that includes managing teams and collaborating with key stakeholders across several time zones. Core business hours are expected from 8am-5pm EST and may consist of ad-hoc urgent responses during audits or inspections conducted by global partners. Candidates with previous experience managing across US Eastern and European time zones are strongly preferred. 

What You'll Do:

• Provide ongoing leadership and oversight to ensure a consistent and compliant approach to understanding SSA needs and focus on continuous improvement to identify efficiencies.
• Executes and monitors compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans
• Act as subject matter expert in Audit / Inspection, including leading Readiness for vendors. Maintained effective tracking of contracts and POs, including expiry, change orders, and scope, to assist operations/upper management with monitoring this work.
• Monitor active contracts for compliance to review requirements, and implement strategies to ensure compliance or corrective actions
• Continuously track existing purchase orders to ensure compliance with Biogen financial policies and track active spending against negotiated contract value.
• Liaise with internal Business Process and Training personnel, Line Managers, PON, and R&D Learning to generate appropriate training that will ensure compliance with revised processes

Who You Are:

You have demonstrated experience leading cross-functional discussion forums to enhance best practice standards by incorporating lessons learned, delta, after-action reviews, industry trends, and audit experiences with a continued focus on quality. Possess strong judgment, problem-solving and decision-making skills focusing on the appropriate level of detail to reach an efficient solution. 

Qualifications

• Bachelor’s Degree in biological, natural science, health care discipline, or directly related field. Advanced Degree (Ph.D., MPH, NP, PharmD, etc.) preferred. 
• Seven (7) years of pharmaceutical/biotechnology industry experience within vendor management/outsourcing and fully proficient in vendor contract negotiation and execution. Prior Pharmacovigilence experience is strongly preferred.
• Knowledge and experience of vendor oversight, contracting and financial processes, aggregate reports writing/authoring, and signal detection activities.
• Excellent written and verbal communication skills required.
• Demonstrated ability to work proactively and independently with minimal oversight needed by management.
• Strong organizational skills, including the ability to handle complex tasks, prioritize effectively, and project management initiatives/process improvements.
• Excellent people and customer service skills demonstrating an ability to work as a team player within SSA, interacting with all levels of staff, both internal and external to the company, to establish good partnerships/alliances.
• Financial solid negotiation skills and management experience are desirable.

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

The base compensation range for this role is $116,500 to $187,800. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and ma