Senior Safety Evaluation Physician/General Safety Officer

Eisai EMEA; Hatfield; Hybrid; GBP 90,000 - 140,000; Full time

Benefits offered by this job

Hybrid working

Car/Car Allowance

Electric charging points for EVs

Discretionary Bonus

Free onsite parking

Onsite restaurant and coffee shop

Learning and development opportunities

Well-being & mental health programs

Multi-faith prayer room

Job summary

Eisai EMEA is seeking a Senior Safety Evaluation Physician / General Safety Officer to support the Head of Safety Evaluation and EU QPPV in delivering a comprehensive pharmacovigilance service across Europe and internationally.

You will lead safety evaluation, signal detection, and safety reporting, plus provide safety guidance for clinical studies and risk management plans within a global drug safety network.

Qualifications

• Must hold UK GMC-approved medical registration.
• Experience in pharmacovigilance with a track record of strong contribution.
• Experience in pharmacovigilance for oncology products is advantageous.
• Post-registration clinical medicine experience is required.

Responsibilities

• Act as General Safety Officer (GSO) to manage global safety for a product or group of products.
• Lead safety evaluation, signal detection, and aggregate safety reporting.
• Respond to safety-related queries from regulators and external bodies.
• Provide safety expertise for risk management plans and safety information updates.
• Contribute to safety aspects of designing and running clinical studies, including SARs/SSRs.

Skills

UK GMC registration

Pharmacovigilance experience

Oncology pharmacovigilance

Clinical medicine experience

Education

Medical degree

Job description

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.

By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

The Senior Safety Evaluation Physician / General Safety Officer will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV), and the Eisai global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service to Eisai internationally and in Europe.

Main responsibilities

• As assigned by the Global Safety Board Chair, act as General Safety Officer (GSO) to proactively manage the global safety aspects for a specific product, or group of products as defined in company policies and SOPs
• As GSO, be responsible for leading safety evaluation for specified products, including signal detection and analysis, aggregate safety reporting and benefit-risk analysis
• Lead the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified products.
• Provide safety expertise to the international project team for assigned products including the production and maintenance of Risk Management Plans
• Lead the production and amendment of safety information, including product labelling for specified products
• Lead the safety-related aspects of the design and running of clinical studies, including involvement in protocol production, investigators’ brochure production, support to the study team, data review, monitoring of safety signals and involvement in the production of the clinical study report.
• Establish and maintain a high level of familiarity with the local, European, and international pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and act as a point of reference for others.
• Be a member of the Global Safety Board – the body which manages pharmacovigilance globally for Eisai
• Contribute as a senior and respected member of the drug safety community in the day-to-day functioning of an effective regional and global drug safety network

What are we looking for

• The Senior Safety Evaluation Physician will be expected to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.
• The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution was demonstrated, in addition to success in tackling new challenges and responsibilities.
• Previous experience of pharmacovigilance for oncology products in development and/or on the market would be an advantage.
• There is scope for the Senior Safety Evaluation Physician to attend appropriate scientific and medical courses as appropriate for maintaining basic medical knowledge, for advancing skills as appropriate to those drugs for which he/she is responsible, for maintaining and expanding skills associated with safety surveillance and post-graduate medical specialty training in pharmaceutical medicine.

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Hybrid working (Depending on role)
• Car/Car Allowance (Depending on role)
• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society.

Our commitment is

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity