PV Safety Lead
- Recruiter
- Achieva Group Ltd
- Location
- Welwyn Garden City
- Salary
- Competitive
- Posted
- 01 Jul 2022
- Closes
- 28 Jul 2022
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
Job Description
PV Partnering Specialist/Lead
This role is outside IR35.
18 months until Dec 2023.
Based at Welwyn - Hybrid working with 1-2 days in the office per week.
GBP50 - GBP65 Ltd/UMB pay rate per hour
PV Partnering is accountable for the elements of collection and provision of safety data/information via external sources that require contractual arrangements to be defined and managed to drive effective delivery
Accountable for contributing to the delivery of the Safety Operations strategy, whilst working across a matrix organization and aligning with other PDS and PD functions.
Overall responsible for supporting the management and to facilitate implementation of Safety Agreement processes, templates and systems and oversee quality assurance activities related to safety agreement implementation in close partnership and alignment with respective global and business process owners and appropriate stakeholders. Examples of contractual arrangements requiring safety agreements are all types of Licensing agreements, product and company acquisitions, safety agreements with service providers, all ranges from clinical collaborations, and any new innovative partnerships as the contract landscape evolves.
Responsible to support development and maintenance of user manuals, procedural documentation, information platforms, day to day use and training of systems applied for safety agreements in PDSO, agree on key performance indicators and metrics and this in close alignment and partnership with global and business process owners as well as system owners whilst striving for continuous process and compliance improvement
Experience, Skills, Knowledge:
Good experience in areas relevant to pharmacovigilance system, basic experience in safety agreements management, preferred
Good knowledge of PV system and GVP/GCP regulations and guidelines
Experience in business partner management; sound understanding of contractual set ups requiring safety agreements is a plus
Understanding of the drug development process and regulatory requirements and their impact on safety agreement activities
Good written and verbal communication skills with an international or cross functional perspective, Excellent problem-solving, analytical, impact assessment and strategic and system thinking skills.
Good negotiation skills, Ability to collaborate and communicate effectively and efficiently in an international matrix environment
Conflict management and resolution skills.
Expert knowledge of PV system and GVP/GCP regulations and guidelines
Vast experience in business partner management; sound understanding of contractual set ups requiring safety agreements
Proven track record of effective decision-making; makes good business decisions and exercises sound judgment
PV Partnering Specialist/Lead
This role is outside IR35.
18 months until Dec 2023.
Based at Welwyn - Hybrid working with 1-2 days in the office per week.
GBP50 - GBP65 Ltd/UMB pay rate per hour
PV Partnering is accountable for the elements of collection and provision of safety data/information via external sources that require contractual arrangements to be defined and managed to drive effective delivery
Accountable for contributing to the delivery of the Safety Operations strategy, whilst working across a matrix organization and aligning with other PDS and PD functions.
Overall responsible for supporting the management and to facilitate implementation of Safety Agreement processes, templates and systems and oversee quality assurance activities related to safety agreement implementation in close partnership and alignment with respective global and business process owners and appropriate stakeholders. Examples of contractual arrangements requiring safety agreements are all types of Licensing agreements, product and company acquisitions, safety agreements with service providers, all ranges from clinical collaborations, and any new innovative partnerships as the contract landscape evolves.
Responsible to support development and maintenance of user manuals, procedural documentation, information platforms, day to day use and training of systems applied for safety agreements in PDSO, agree on key performance indicators and metrics and this in close alignment and partnership with global and business process owners as well as system owners whilst striving for continuous process and compliance improvement
Experience, Skills, Knowledge:
Good experience in areas relevant to pharmacovigilance system, basic experience in safety agreements management, preferred
Good knowledge of PV system and GVP/GCP regulations and guidelines
Experience in business partner management; sound understanding of contractual set ups requiring safety agreements is a plus
Understanding of the drug development process and regulatory requirements and their impact on safety agreement activities
Good written and verbal communication skills with an international or cross functional perspective, Excellent problem-solving, analytical, impact assessment and strategic and system thinking skills.
Good negotiation skills, Ability to collaborate and communicate effectively and efficiently in an international matrix environment
Conflict management and resolution skills.
Expert knowledge of PV system and GVP/GCP regulations and guidelines
Vast experience in business partner management; sound understanding of contractual set ups requiring safety agreements
Proven track record of effective decision-making; makes good business decisions and exercises sound judgment