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Drug Safety Manager

Job Title: Drug Safety Manager
Contract Type: Fixed Term
Location: Berkshire
Industry:
Salary: £50000 - £55000 per annum + bonus, car allowance
Start Date: Feb 2017
Reference: 68655-PHARM-JHY
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: January 31, 2017 10:27

Job Description

Job title: Drug Safety Manager
Job type: 15 month FTC
Location: Berkshire / M4 corridor, SE England
Salary: £50,000 - £55,000 / year + bonus, car allowance, company benefits

Summary:

- My client is a research-orientated pharmaceutical company with sites across the
globe
- I have an exciting opportunity to join them on a long term contract basis as a
Drug Safety Manager to head up a newly-formed team
- The successful candidate will have substantial experience of operating at a
management level within Drug Safety

Core responsibilities:

- Lead / manage Pharmacovigilance Staff and Operations
- Create, implement and maintain local PV policies and procedures
- Support the Head of Pharmacovigilance (Local Pharmacovigilance Manager) with
establishing and maintaining a local PV system in compliance with internal
procedures and external requirements (e.g. local and international regulation)

Accountabilities:

- Ensure appropriate single case management including receipt of domestic cases
and distribution to global data entry, response to queries (incl. reminders)
- Tracking and reporting of all received cases to HAs according to local legal
requirements
- Line Management of Local Pharmacovigilance staff
- Provide coaching, encouragement and identification of opportunities for
continuous improvement and self-development
- Continuously assess resource needs
- Deputise for the Local Pharmacovigilance Manager as required and report any
relevant changes to the product portfolio, licensing activities, clinical trial
and post marketing activities, local processes, local PV regulations, audits and
inspections activities and Health Authority requests
- Ensure adequate Safety training of all company staff to ensure that safety data
collection from any source and safety reporting to concerned stakeholders is
performed in compliance with internal procedures and according to current
international regulations
- Establish and support local inspection readiness
- Continuously identify compliance issues and implement CAPAs
- Participate in PV audits and PV inspections and implement post inspection CAPAs
- Perform Safety Surveillance tasks, signal detection for local products and
review safety sections of local labelling
- Coordinate safety issues with local management, the regional PV head and GPV
- Ensure local documentation is in place and in line with global internal
procedures by creating and maintaining a local PV masterfile
- Write PSURs for local products
- Review, assess and track accordingly local trial and non-trial activities and
create and maintain local PV agreements

Required education & knowledge:

- Degree in Life Sciences, Medical, Nursing or Health Sciences
- Substantial previous experience of Pharmacovigilance and knowledge of local and
international Pharmacovigilance regulations
- Previous Line Manager experience
- Experience with the use and management of Safety databases
- Excellent computer literacy with proficiency in MS Windows, Excel, Word and
Outlook

Other requirements:

- Excellent communication and negotiation skills
- Excellent organisational skills, interpersonal and communication skills
- Proven ability to work successfully within a multidisciplinary team
- Proven ability to coach and train others with excellent presentation skills