APCER Pharma (“APCER”) is a global team of experienced, qualified professionals on the ground with Medical and Pharma qualifications and experience that spans North America, Europe & Asia. Within this global framework, APCER has built local teams of qualified professionals in different countries to strategically tap the best available resources in order to provide services to our customers.
Post: Documentation/Medical Writing
Role involves writing a range of documentation for the company’s clients, including Safety reports like PSURs, addendum and summary bridging reports, narratives and the safety sections of PSURs.
· Preparation/Review of PSURs as per Regulations and SOPs
· Preparation/Review of periodic reports including Addendum and Summary Bridging Reports.
· Interact with employees at various levels and in various functional areas to address issues found during reviews.
· Evaluate comments from reviewers of draft reports for appropriateness and respond accordingly
· Constantly (re)prioritize work to manage projects often requiring multitasking skills. Data cleaning/QC skills.
· Execution and support in development of Company Standard Operating Procedures
· Liaise effectively and maintain excellent relationship with the clients and internal/external contacts
· To contact, as required, UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines
· Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
The candidate should have the following attributes:
· Global Safety-Regulatory Knowledge
· Able to interpret and apply global regulations and guidelines relating to Pharmacovigilance
· Prior exposure to PSUR writing
· Computer proficient with exceptional attention to detail
· UK monitoring experience is prerequisite for this role
· Previous experience within Pharmacovigilance is preferable
· Effective written communication and management skills
Experience: 2-3 years
Education: B.Pharm, M.Pharm, MBBS-Medicine
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Medical
End Date: 2nd July, 2011
forward your CV to, Ranjana.Ghosh@apcpharma.co.uk
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