Pharmacovigilance Partner Alliance Manager

The Pharmacovigilance (PV) Partner Alliance Manager is responsible for managing the PV relationships with Essential Pharma’s external partners and licensors. This role ensures all partnerships are supported by robust safety agreements and maintains clear oversight of safety activity across partner markets, while leading the onboarding of new partners into Essential Pharma’s safety framework. If you are keen to join a patient centric, high-growth company, then read on and apply today!

Responsibilities

• Coordinate negotiation and maintenance of pharmacovigilance agreements (PVAs) with all partners, ensuring agreements are in place before marketing authorisation transfer (MAT).
• Maintain visibility of PV requirements and activity across all partner markets, acting as the primary safety point of contact for partners.
• Coordinate integration of safety signal management with partners, agreeing how signals are identified, assessed, escalated and communicated.
• Clarify and monitor safety variation submission requirements, ensuring label related changes are tracked and delivered on time, including initiation and processing activities through our change control system
• Clarify and manage aggregate safety reporting obligations for each partner product, including what must be submitted and when.
• Coordinate pharmacovigilance set up for patient support programmes (PSP), including development of PV training and establishment of the relevant PVA.
• Collaborate with the PV vendor to ensure new partners and PVA requirements are captured within our PV system.
• Contribute to updates of the MAH oversight procedure, related SOPs and the PSMF
• Maintain accurate records of all partner PV agreements, oversight activity and safety commitments, and report progress against PV objectives to the VP of Pharmacovigilance
• Contribute to maintaining a compliant and inspection ready PV system, including Change control and deviation handling within our QMS
• To maintain GxP compliance regulations to ensure that the applicable standards and regulations are adhered at all times. This includes following of standard operating procedures and approved written documentation.

Requirements

Qualifications

• Life sciences, pharmacy or related degree, or equivalent professional experience.

Experience

• Solid experience in pharmacovigilance, ideally including partner or vendor oversight, PVA negotiation, or M&A safety integration.
• Working knowledge of aggregate safety reporting, signal management and safety variation requirements.
• Experience operating in, or alongside, outsourced PV service models is an advantage.
• Experience with Pharmacovigilance legislation outside of UK and EU is an advantage

Core Competencies

• Strong relationship management skills, comfortable representing PV externally with partners and vendors.
• Well organised, able to track multiple partner agreements and deadlines in parallel.
• Clear communicator, able to translate PV requirements into practical, partner facing agreements.
• Strong Agile thinker who can adapt to situations of high-speed change
• Problem solver who can work through complex issues
• Candidate must demonstrate a Growth mindset and willingness to learn
• Must demonstrate integrity and high ethical standards
• Previous demonstration of working effectively as part of team with strong collaboration
• Demonstrates a willingness to achieve goals together and respect the view of others
• Results orientated and accountable for actions

Benefits

What We Offer

• Competitive salary
• We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
• Healthcare
• Pension – you contribute 5% and we offer 5%
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary
• Enhanced family leave
• Enhanced sick pay
• 25 days annual leave
• Discretionary annual performance bonus

What To Expect

• At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us
• Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious
• This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success
• We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives
• We have an unwavering dedication to employee growth and development