Hendre Moolman at CK Clinical is currently recruiting for a Senior Medical Advisor to be based in Cambridgeshire. This position is with a company in the pharmaceutical sector who specialise in pharmacovigilance, medical monitoring and regulatory affairs.
The role:
As Senior Medical Advisor you will be required to review and advise on serious adverse events and non-serious adverse events arising in both clinical studies and the post marketing environment.
Responsibilities:
- Provide medical input to the Regulatory and Pharmacovigilance departments including generating appropriate sections of regulatory and other documents
- Provide medical monitoring services for client’s clinical studies, including assessment and granting of waivers, reviewing inclusion and exclusion criteria and reviewing of laboratory and other data
- Review and advise on serious adverse events and non-serious adverse events arising in both clinical studies and the post marketing environment
- Liaise with medical departments in client companies and attend project meetings if required.
- Liaise with external regulatory authorities as required
- Provide review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling for medical accuracy
- Assist the Chairman and other project staff in writing bids, contracts and other project related documents
- Assist in the preparation of Standard Operating Procedures (SOPs)
- Provide medical information if required by clients
- Participate in training as required both for internal staff and at Investigator or client meetings
- Mentor medical advisers and support their training and development.
- Contribute to and supervise the production of client documents and reports, including protocols and relevant sections of Clinical Study Reports
- Provide medical review of protocols and study reports for clients
- Provide medical review of and input to Standard Operating Procedures
- Support the Pharmacovigilance group in the production of Regulatory
- Authority and Ethics Committee documentation
- Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
The ideal candidate:
To be considered for this Senior Medical Advisor position you will have the following qualifications, experience and skills:
- Medically qualified, with a qualification recognised in the European Union
- A minimum of 5 years experience in a related field, preferably in the pharmaceutical industry or a CRO
- Ideally a higher qualification, preferably in Pharmaceutical Medicine
- Sound analytical skills
- Effective oral and written communication skills
- Management experience
- Good computer skills and the ability to learn appropriate software
- Good understanding of relevant software, MS Word, MS Excel
- Good English language and grammar skills
How to apply:
For more information or to apply for this Senior Medical Advisor role, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL23089 in all correspondence.
