The Senior Pharmacovigilance Manager is a member of the Biosimilars Business Unit, reporting to the Head of Patient Safety, BBU. This role will be responsible for establishing governance and defining standards for interactions with third party business partners in pharmacovigilance and for co-ordinating regional PV provisions for the Biogen Biosimilars Unit (BBU), overseeing a global network of local safety responsibles.  The candidate will work closely with the Global Head of Pharmacovigilance, Biosimilars, the EU-QPPV and other PV staff to establish and maintain compliant and effective processes and interfaces for the areas mentioned above, including participation in auditing and inspection processes as needed. A major part of the activities will be around the existing business partnership between BBU and Samsung Bioepis (SB).

• Establish and maintain safety strategies for assigned products throughout lifecycle
• Support the development, improvement and implementation of novel PV processes for BBU
• Support interactions with third party development partners and due diligence processes

Minimum Education Requirements

• BS or MS in scientific field (e.g., biology, pharmacy, biochemistry)
• At least 7 years (BS) or 5 years (MS) relevant work experience in pharmacovigilance
• Additional education in pharmacovigilance/pharmacoepidemiology/public health is an asset (e.g., MPH)

Minimum Experience Requirements

• Strong orientation towards cross-functional teamwork
• Biosimilars experience is an asset
• Relevant levels and types of scientific/medical/PV expertise
• Hands on experience in the development of signal, risk and benefit-risk management strategies
• Strategic thinking & strong analytical ability - able to apply critical and holistic thinking in terms of safety for ‘overall value add’ to deliver effective impact for cross-functional teams
• High degree of knowledge of PV tools and methods of managing risk and when/how to deploy; keen to apply new ways of working, tools/technologies relevant to safety science as they emerge
• Ability to work independently with strong analytical skills and attention to detail.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Excellent written and verbal communication skills, fluent business level English.

The ideal candidate will have the following experience:

• Demonstrated ability to drive and implement complex initiatives across a matrix organization
• Demonstrated ability to envision and influence operational strategies
• Experience in a commercial organization
• Proven ability to create solid project plans and to manage full life cycle of project execution with rigour and discipline around deliverable creation and quality
• Excellent problem-solving skills, leadership qualities, influencing, communicating, and consulting skills, team/interpersonal skills
• Ability to work collaboratively with others from any functional area or background, to influence thinking, and gain acceptance
• Ability to comfortably work with both technical and non-technical audiences and to work with and through all levels in an organization
• Solid financial acumen and ability to develop business cases that support new or improved project proposals
• International experience: Self-awareness of communication style and cultural differences.
• Consultative style: Ability to formulate and articulate a perspective and present it in a manner that generates understanding and alignment
• Self-motivated and capable of operating independently with limited oversight. Strong sense of personal accountability for work tasks
• Comfortable acting in a role as individual contributor and influencer
• Comfort dealing with ambiguity and a fast-paced entrepreneurial environment