Senior Manager, Pharmacovigilance Agreements
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 134000 - 179000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
As the Pharmacovigilance Agreement (PVA) Senior Manager you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning visualization and archival systems required for on-time development and marketed product SDEAs PV transfer agreements and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogens product pipeline and portfolio.
What Youll Do
- Conduct timely outreach for SDEA planning authoring and stakeholder and corporate partner transparency
- Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports
- Act as an SDEA subject matter expert for audit and inspections and SDEA inbox management
- Lead partial or full SDEA and/or PV transition executions with internal SMEs and Corporate Partners
- Conduct QC on signature ready SDEAs and lead the execution and document maintenance process
- Map SDEA commitments for responsible party awareness of SDEA accountabilities
- Manage and enhance processes for SDEA execution compliance and transparency
Who You Are
You are results driven and emotionally intelligent contributor with a strong foundation in GVP. You have a collaborative and consensus building mindset and can manage multiple projects and agreements simultaneously and are flexible with changing timelines to achieve timely SDEA executions. You exercise good judgement on responsible communication. Your attention to detail and continuous improvement mindset yields high quality results and has broad reaching time saving impacts.
Required Skills
- Bachelors degree in life sciences and 5 years of industry experience in pharmacovigilance or GVP related field
- Leadership of or experience with the review of safety agreements or safety contracts
- Excellent attention to detail
- Ability to collaborate across many levels and roles to successfully influence without authority to achieve agreeable and compliant outcomes
- Strong oral and written communication and negotiation skills
- Flexibility and ability to prioritize and manage competing priorities
- Familiar with working with complex corporate relationships
- Familiar with the drug development lifecycle and applicable industry regulations
- Strong proficiency in Microsoft Word
Preferred Skills
- Enjoys building and maintaining cross-functional relationships and engaging others for optimal outcomes
- Equal ability to work independently and lead
- Audit and inspection participation as a subject matter expert
- Project management and document management skills
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Senior Manager
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
