Your tasks and responsibilities
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Bayer's PV team has a current opportunity for a Local Safety Physician.
• Assist in the maintenance of company compliance with respect to laws, regulations and guidance associated with the licensure of Bayer UK medicinal products with respect to patient safety
• Keep current with emerging UK law, regulations and guidelines and assure process compliance with local guidelines and standards for safety reporting. Assure compliance to local regulatory reporting requirements and local and global processes.
• Review of relevant Pharmacovigilance sections in local Study Protocols and Informed Consents, Patient Information, Summary of Product Characteristics, Prescribing Information and Patient Information leaflets
• Provide local support of safety related medical enquiries, liaising with the respective Global function
• Drive local Risk Management activities by leading local Safety Management Team meetings and implementing and tracking Risk Minimisation Activities
• Embed safety, especially benefit risk aspects, into medical and commercial projects and activities through pro-active engagement and outreach to those internally responsible
• Drive safety discussions around Bayer’s products with internal and external key customers
• Monitor and inform proactively on local safety aspects as needed
• Ensure oversight of PV relevant activities by liaising with the local organisation and third parties.
• Support the PV Process Manager by delivering training on PV related topics to the local organisation
• Provide medical expertise in safety topics with cross-functional teams (e.g. assessment of serious breaches in clinical trials, PQSCs, etc.)
• Deputise for the PV Country Head
Who you are
• Medically qualified, Diploma in Pharmaceutical Medicine is desirable
• Be familiar with industry principles of drug development, pharmacology, biostatistics, clinical trial methodology, health regulations/legislations and pharmacoepidemiology
• Has excellent interpersonal, decision-making, administration, organisation and supervision skills, follows through on agreed measures.
• Must have demonstrated problem solving skills especially with respect to enforcing safety rules and global procedures.
• Excellent clinical interpretational skills based on limited information provided.
• Excellent oral and communication skills are essential, including fluency in English.
• Must possess a high degree of overall poise, tact and courtesy; must be detail and process oriented; willing to work in a hectic pace environment with time-sensitive materials.
• Proactive behaviour and ability to keep timelines
• High degree of responsibility and accountability
• Ability to develop cooperative working relationships with all levels of staff is critical
• Must be proficient in using Microsoft Office programs such as Excel and Word
• Knowledge of ABPI Code of Practice is desirable.