Pharmacovigilance Regulatory Intelligence Specialist

6 months ago


Weybridge, United Kingdom Clinigen Full time

The Pharmacovigilance (PV) Regulatory Intelligence Specialist will serve as the Lead for managing PV Agreements for Managed Access programs, Global Access programs, Commercial Medicines partnerships and will be responsible for ensuring the timely and compliant handling of safety information received by Clinigen. Additionally, the role involves monitoring sources of PV Regulatory Intelligence and PV requirements.

**Key Responsibilities**:

- Leads the preparation, negotiation and approval of PV Agreements relating to Managed Access programs, Global Access programs, Commercial Medicines partnerships;
- Monitors sources of Pharmacovigilance requirements e.g. agency websites, Cortellis etc and develop and coordinate with global network to obtain and maintain awareness of current and evolving local Pharmacovigilance Regulatory Requirements for clinical, post-marketing and unlicensed medicinal product use;
- Ensures PV services have been agreed with the Client/Partner prior to start-up of the program and that all PV documentation has been completed;
- Drafts and reviews Safety Data Exchange Agreements (SDEA)/Pharmacovigilance Agreements (PVA) (or equivalent document) for assigned projects;
- Represents PV Team and interacts with MA/GA/Commercial team and Client/Partners on a regular basis;
- Liaise with client to provide training for the DS team if needed for the set-up of the MA/GA/Commercial program;
- Maintains oversight and awareness regarding compliance of PV service requirements and ensure any non-compliance is escalated and managed appropriately;
- Ensures implementation of client/programme requirements within the PV team (e.g. client special requirement document; partner management tracker);
- Support the MA/GA team with Client Business Development activities including attendance at program kick off meetings.
- Provides support and back up to PV Manager, Regulatory Intelligence & Partner Alliance Management;
- Ensure all patient safety issues are escalated and processed promptly; including timely transmission of adverse event reports to the supplier or manufacturer, at all times managing the clients’ expectations, and ensuring that regulations and processes are adhered;
- Responsible for raising and investigating deviations/non-compliance and developing and implementing appropriate corrective and preventative actions in a timely manner;
- Participate and provide support in PV Inspections and Audits

**Requirements**:

- Bachelor's Degree in Biological/Life Sciences, Pharmacy or Medicine or equivalent
- Proven and demonstrable experience in the Drug Safety/Pharmacovigilance field in the Pharmaceutical Industry
- Previous experience of preparation of Safety Data Exchange Agreements/PV Agreements required
- Previous experience of PV Regulatory Intelligence screening desirable
- Evidence of being able to build relationships with key internal and external Customers/Partners and demonstrate Customer focus
- Proven experience of working to meet high standards and provide excellent customer service
- Excellent attention to details and evidence of ability to work under pressure
- Prioritisation and time management skills
- Extensive knowledge of MS Office Applications and systems
- Positive can-do attitude
- Excellent written, verbal and interpersonal communication skills
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Willing to provide bank holiday coverage on a rotational basis.

**Benefits**
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards



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