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Job Details

PW-7032 Head of Pharmacovigilance /Affiliate Safety Representative

Company: AXESS
Location: South East
Reference: PW-7032
Closing Date: 20 May 18
Type: Permanent
Salary (£): Competitive
Benefits: LTIs plus Car, Bonus, Medical and Pension.

Job Summary:

Strategic leadership role as Head of Pharmacovigilance for a blue-chip Pharma organisation. Will involve the management of a small, but specialist PV team and multiple external vendors.

Requirements:

BACKGROUND

Blue-chip Pharmaceutical Organisation

Leadership Role

UK Remit including line and vendor management

Reporting to UK Medical Director

 

PRIMARY DUTIES

Lead the strategy for the UK PV operation and manage a small but specialist PV group.

Build strong connections across Affiliate functions with the PV team.

Collaborate with other Affiliate PV teams and PPS to share best practice and contribute to regional/area/global projects and other initiatives.

Drive a culture of patient safety across all business activities.

Maintain oversight of all aspects of the performance and functioning of the PV system, including compliance with local regulations, internal company timelines/standards and partner/service provider compliance.

Act as the key Affiliate contact for internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV inspections.

Maintain awareness of any local Regulatory Agency safety request and liaison with Regulatory Affairs to enable timely notification to global RA and PV teams and appropriate response to requestor.

Negotiation, development and maintenance of PV-related agreements and contracts with partner companies/vendors, working with PPS to ensure conformance to global standards.

Ensure training of all affiliate personnel (including global or area / regional staff based at the Affiliate) and affiliate service provider staff on relevant PV responsibilities at least annually, with appropriate documentation.

Ensure the scheduling of locally required Periodic Safety reports (clinical and post-marketing), and submission to Regulatory Authority, Ethics Committees and Investigators as required in accordance with the due dates.

Core team member of the Affiliate Risk Management Team (ARMT); contribute to the strategy for effective risk management plan implementation.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Life science or medical degree.

Previous and extensive experience in pharmacovigilance.

Previous line management and UK affiliate level experience whilst not mandatory would be an advantage.

Effective decision maker who possesses the ability to assess impact of actions taken locally on the global PV system.

Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety.

Raises the bar and motivates others to a higher standard of performance.

Creates a learning environment, open to suggestions for improvement.

Deals comfortably with ambiguity and uncertain risk.

 

Our client will not sponsor work permits for nationals who are unable to work freely in the UK.  Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

TO APPLY:

For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-7032.

 

Keywords:

Pharmacovigilance / PVG / Drug Safety / MHRA / Vendor Management / Head of PV / Head of Drug Safety / Head of Pharmacovigilance / PV Line Management / UK PV Director / PV Director / PV Associate Director / Head of Pharmacovigilance / PV Senior Manager / London / South East / UK / Affiliate Safety Representative / Affiliate / Berkshire / Line Management / GPV / Compliance / CAPA / Patient Support Programmes / Market Research Programmes / Drug Safety Physician /  

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

Apply for this job:  PW-7032 Head of Pharmacovigilance /Affiliate Safety Representative

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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