Zentiva Pharma UK Ltd is a leading manufacturer of generic pharmaceutical products throughout the UK and Europe. With more than 4,700 people across 30 countries and 3 production sites in Prague, Bucharest and India, we strive to be the champions of Generics and Over The Counter (OTC) medicines to better support people's daily healthcare needs.
JOB PURPOSE
* The Scientific Information Officer will adeptly handle medical and scientific enquiries received via phone, email, or mail, ensuring that all responses are formulated in accordance with Zentiva's policies and procedures.
MAIN ACCOUNTABILITIES AND DUTIES
* Research and respond to medical enquiries received from both internal and external customers, adhering to mutually agreed deadlines.
* Document all interactions accurately and completely according to relevant Standard Operating Procedure (SOP)/ Work Instruction (WI), and regulatory guidelines.
* Coordinate and escalate enquiries to the relevant person when required to ensure timely and compliant responses.
* Identify Adverse Events and Product Quality Complaints, reporting them promptly and accurately to the Pharmacovigilance/Quality departments in strict compliance with relevant procedures.
* Manage the Medical Information (MI) mailbox.
* Keep the repository of Frequently Asked Questions (FAQs), their answers, and response templates current, ensuring all materials are scientifically accurate and fully referenced. Regularly monitor key performance indicators to ensure all MI enquiries have been answered within timelines.
* Ensure and support audit readiness for MI at all times.
* Develops an in-depth knowledge of Zentiva products and relevant therapeutic areas, providing expertise and advice to others within the UK organisation.
* Analyse medical information enquiries to identify trends and inform product improvements.
* Regularly evaluate and refine MI procedures to optimise efficiency and take responsibility for updating relevant MI SOPs /Quality documents.
* Manage essential information resources, including databases, factsheets, and other technical materials.
* Effective engagement with other functions.
* Possess a practical understanding of relevant company policies, regulations, and legislation, including familiarity with the ABPI Code of Practice.
OTHER RESPONSIBILITIES
QUALITY
* Adheres to the principles of GxP in the extent related to the performed activity. Is obliged to regularly train in this policy.
HSE
* Adheres to the principles communicated within the Environment and Safety Management System (ESMS) Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.
PHARMACOVIGILANCE
* All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.
COMPLIANCE
* The employee will comply with all internal rules and policies of the Company. The employee will make themselves acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.
KEY WORKING RELATIONSHIPS
INTERNAL
* Work cross functionally with internal teams including:
o Pharmacovigilance
o Global Medical Affairs
o Regulatory Affairs, Quality
o Key Account Managers
o Commercial
EXTERNAL
* Grow and maintain strong relationships with:
o MHRA
o Trade industry bodies
o Healthcare Professionals and Healthcare Organisations
o Patients and patient organisations
o Other Pharmaceutical Companies
REQUIRED QUALIFICATIONS, EXPERIENCE AND SKILLS
* Life science degree or qualified Healthcare Professional (e.g. pharmacy technician, pharmacist, nurse).
* At least 1-2 years' experience in Medical Information or related field.
* Additional experience in the pharmaceutical industry or a related field would be advantageous.
* Strong communication, organisational, and analytical thinking skills.
* Customer-focused mindset with problem solving aptitude.
* Excellent information management and attention to detail.
* Ability to conduct comprehensive literature searches and distil relevant information.
* Understanding of basic pharmacovigilance concepts and requirements.
Zentiva Core Values
Purpose - Providing health & wellbeing for all generations.
Accountability - Taking ownership of every action and every word, and delivering what you promise.
Authenticity - Bringing yourself to work each day with instinct and passion, but also with acceptance, honesty and kindness.
Collaboration - Making sure we all work together, empowering people with equal access to tools, processes, information and training in the right place at the right time.
Courage - Providing a framework for proactive engagement where all are enabled to challenge, innovate and dream a little in a safe and inclusive environment.
Trust - Enabling an open environment where feedback is encouraged, supported and respected, wellbeing prioritised and Once Voice underpins honesty and transparency.
Sustainability - Doing the right thing for People, Partner and Planet.