Senior Manager, Pharmacovigilance Agreements
About The Position
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 Biogen’s product pipeline and portfolio. What You’ll 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.
Requirements
- Bachelor’s 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- 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 $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
