PV/SDEA - Safety Alliance Manager (REMOTE OR OFFICE BASED) - Berkshire, UK
Expiry Date: 18-06-2021
Job Type: Full Time
Windsor and Maidenhead
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PV/SDEA - Safety Alliance Manager (REMOTE OR OFFICE BASED) - Berkshire
To strengthen my Clients Patient Safety Team, we are looking for a talented individual to fill the position of: PV/SDEA - Safety Alliance Manager.
As a PV/SDEA - Safety Alliance Manager, you will collaborate with internal stakeholders and external business partners in the end-to-end lifecycle management of Safety Data Exchange Agreements (SDEA) / Pharmacovigilance Agreements (PVA):
- Lead the preparation, negotiation and conclusion of SDEAs/ PVAs relating to Development and Commercial partnerships.
- Support the establishment and maintenance of SDEA/ PVA related business processes, standards and systems.
- Act as a key contact point on all matters relating to SDEAs/ PVAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
- Ensure oversight on all assigned SDEAs/ PVAs, contractual obligations and associated deliverables throughout the lifecycle of the partnership.
- Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
- Actively support audits and inspections as well as resolution of CAPAs.
You should have:
- Bachelor's degree is required, Master’s degree is preferred.
- At least 3 years’ experience in pharmacovigilance, regulatory, quality, legal, contract management and/ or compliance related role.
- Good working knowledge of global clinical and pharmacovigilance regulations and guidelines. General understanding of the functional requirements for all critical pharmacovigilance processes.
- Good understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is preferred.
- Strong critical thinking/ analytical skills and attention to detail.
- Good negotiation and problem-solving skills.
- Effective time management skills and ability to adapt to changing priorities.
- Excellent oral and written communication skills - Proficient in English.
- Strong team orientation, experience and ability to work in a cross-functional and cross-cultural environment.
- Self-starter and ability to work autonomously.
** CAN BE REMOTE OR OFFICE BASED **
To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to firstname.lastname@example.org. Alternatively, please press the red “Apply for position” button and follow the registration process.
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