Local Safety Officer – Bulgaria

Excelya is currently seeking for a qualified candidate to join our Pharmacovigilance team for the position of Local Safety Officer based in Bulgaria. We are seeking a candidate who will be collaborate with us as Freelancer, dedicated to one client. The ideal candidate will be accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the affiliate. The candidate will act as nominated contact person for pharmacovigilance (“Local QPPV” equivalent) to the local Health Authorities.

Main Responsibilities

• Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance

(QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings

• Ensure that the required local information for the Pharmacovigilance System Master File

(PSMF) is made available to the EEA QPPV office, either directly or through local delegations

•Implement and maintain a pharmacovigilance system for the client products authorized in

the territory and ensure compliance with applicable regulatory and company requirements

• Work in close collaboration with corporate Patient Safety teams to ensure that local

obligations are managed and compliance to local authorities is maintained

• Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs;

• Maintain oversight of local deliverables delegated to service providers;

• Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate. Patient Support Programs/Market Research programs/Digital initiatives

• Collaborate in true partnership with business units in programs leading to solutions for patients plus ensure compliant set up and oversight;

• Proactive assessment of the capability and capacity of PSP/MRP vendors to conduct critical pharmacovigilance tasks (in support of qualification audits) and avoid issues of regulatory compliance Proactive Regulatory Intelligence

• Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to corporate teams (including EEA QPPV), local stakeholders;

• Knowledge of product safety risks to act proactively and independently with local stakeholders and proactively escalate local safety issues to the Safety Leads as appropriate;

• Champion the coordination and enable effective safety communication to HAs/HCPs and patients and ensure appropriate follow-up Health Authority inspections and Audit readiness

• Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance;

• Ensure that all information relevant to the benefit/risk balance of the client’s products is reported to Patient Safety (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation;

• Act as local Subject Matter Expert on product safety, contributing to the product lifecycle

activities, product information (e.g. labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Management Plan as applicable;

• Participate in product launch strategic meetings and ensure safety related reporting trainings Stakeholder Management

• Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training;

Education & Qualification

• Holds a Bachelor degree in Life Sciences (such as physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area (such as PhD/master in biological sciences or related degree)

• Proven working experience in Pharmacovigilance at least 3-5 years. Scientific background in Central Nervous System and/or immunology therapeutic areas

• Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory

requirements;

• Have strong interpersonal skills, especially in the area of individual leadership and

adaptability;

•Ability to lead and motivate and influence in matrix organizations at the Affiliate;

• Role model – high level of integrity and honesty, both internally and externally. Able to

inspire direct team and others;

•Excellent oral and written communication skills as the individual in this position will be

interacting with multiple levels and diverse functions

• Excellent verbal and written communication in English (specify any local language skills

according to local requirements, if any);

•Professional demeanor, team orientated, self-motivated, and ability to influence

stakeholders both externally and internally;

•Problem solving:

a) Solid foundation for making quick, sound decisions, based on limited information

b) Ability identify gaps, perform trend analysis and implement risk mitigation strategy