Pharmacovigilance and Scientific Information Manager

Be a part of the winning culture!

At Zentiva, we are a team of 4.800 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Pharmacovigilance and Scientific Information Manager

Currently, we are looking for a Pharmacovigilance and Scientific Information Manager to join our highly motivated and inspired team in Zentiva UK. The PV and SI Manager provides PV and SI expertise, leadership, mentorship, and supervision to his/her direct reports and assists in the management of medical, scientific, and administrative responsibilities.

What Would Be Your Main Responsibilities

PHARMACOVIGILANCE: As the UK National Contact Person for Pharmacovigilance (NCPP):

• Maintain oversight of all UK PV cases (including cases received via health authorities),
• Act as the primary PV contact person for the MHRA,
• Monitor compliance of UK PV case and aggregate report submissions,
• Author and maintain the UK pharmacovigilance system master file (PSMF),
• Ensure that the UK Qualified Person for pharmacovigilance (QPPV) is kept fully aware of all UK PV specific information,
• Be registered with and accessible to MHRA 24/7 in case of urgent safety situations.

Additionally, the PV and SI Manager will:

• Act as the Local Pharmacovigilance (LPV) contact for UK and Ireland.
• Oversee PV case management of direct reports to ensure all PV cases are sent to Global Pharmacovigilance (GPV)/ Business partners within timelines.
• Maintain all PV Standard Operating Procedures (SOPs)/quality documents to ensure they reflect the most efficient processes and are in line with regulatory and GPV requirements.
• Review and oversee management of local Safety Data Exchange Agreements (SDEAs) by direct reports.
• Ensure compliance of all PV activities including risk management and signal detection.
• Monitor compliance of safety updates requested by health authorities.
• Represent the UK PV department internally and externally at a global level and function as an authoritative and professional member of the Scientific Affairs team.
• Collaborate with GPV as required.
• Ensure timely resolution of corrective and preventative actions for safety related issues.
• Maintain and provide a current understanding of Good Pharmacovigilance Practise (GvP)/legislation and industry best practises including innovative approaches to problem solving and/or change management.
• Ensure all PV processes and data are kept in an inspection and audit ready condition at all times.
• Lead and participate in any UK PV inspections and audits.
• Manage the pregnancy prevention programes for Thalidomide and Lenalidomide and any other products requiring pregnancy prevention programmes marketed in the UK or Ireland.

SCIENTIFIC INFORMATION:

• Maintain oversight of Medical Information (MI) management to ensure high quality delivery of MI and provide support to direct reports as required.
• Provide support to direct reports for complex medical enquiries.
• Ensure all MI SOPs/quality documents reflect the most efficient processes and are in line with regulatory and Zentiva global medical requirements.
• Ensure all SI processes and data are kept in an inspection and audit ready condition at all times.
• Lead and participate in any UK MI inspections and audits.
• Assist the Head of Scientific Affairs in fulfilling the ethical compliance function for the Affiliate which is in line with the relevant legislation and Corporate Compliance Guidelines

MANAGEMENT OF RESOURCES:

• Adheres to company-defined processes for the selection of and agreement of commercial terms with vendors.
• Understands and uses internal procedures and tools to ensure the compliant and efficient operation of the “Purchase to Pay” process.

PEOPLE LEADERSHIP:

• Performance manages the team through setting and reviewing priorities.  Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
• Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
• Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams

We Need You To Have

• Life science degree or qualified Health Professional (e.g. pharmacy technician, pharmacist, nurse)
• 5-10 years’ experience within pharmacovigilance.
• Previous line management responsibilities would be advantageous.

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

• Competitive salary;

• Additional benefit package;
• International working environment and a passionate team of professionals;
• Continuous Learning & Development opportunities thanks to our Zentiva Academy.

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of almost 4,800 unique talents bonded together by our mission to deliver high quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva