Associate Director International PV

Join our Pharmacovigilance team as Associate Director International PV.Associate Director International PV is responsible for the leadership and oversight of the international PV office, ensuring compliance with international regulations, guidelines and internal quality standards, and alignment with the QPPV office strategy and governance. The role oversees and manages a team of EU/UK QPPVs and PV personnel and may additionally overtake EU/UK QPPVs role. The role supports the operational, financial, and client objectives of the sub-department, driving process excellence and effective management of PV operational activities.Role is open for candidates in any EU country. All CVs must be submitted in the English language for consideration.Responsibilities:Management of Full Pharmacovigilance systems and projects (or part of them) and ensure oversight of the full PV systemSupport execution of the QPPV Office strategy, oversee strategic/key accounts. Maintain and improve the functioning and efficiency of the QPPV officeInfluence the performance of the quality system and PV activities and drive quality improvements and process harmonization across regionsOversee sub department forecasting and contribute to budget planning ensuring efficient functioning of the QPPV Office. Support with pharmacovigilance RFI and RFP documents Support the maintenance of the Pharmacovigilance System Master File (PSMF) and oversight of local annexes and related governance documentationManage PV projects and customer activities, supervising core PV deliverables. Overseeing PSURs, RMPs, literature monitoring, SOP updating, safety information handling and signal managementEnsure oversight of the contractual partner safety data exchange agreementsOversee inspection/audit strategy, readiness, and finding remediationMonitor regulatory changes and ensure PV compliance (legal, procedural, and contractual) across assigned projects, by reporting non-compliance promptly. Act as subject matter expert for PV in assigned company processesManage assigned team (regional QPPVs), including setting goals, evaluating performance, and supporting decisions on promotions, compensation review, and competence developmentOversee resource planning and allocation, including identifying staffing needs and participating in recruitmentMay Act as the Project Manager or deputy Project Manager for the assigned projects in accordance with a separate Job Description (if applicable)May act as the appointed EU/UK QPPV or deputy EU/UK QPPV in accordance with a separate QPPV Job Description (if applicable)Identify areas for improvement and proactively propose solutions within the area of responsibilityPerform additional tasks related to the department’s activities in the absence of another employee or staff member of the same department RequirementsBiologist, Pharmacist, Medical Doctor, or other life science degreeAt least 6 years of work experience in PV functions and 1 year of experience in managing PV teams Team management experienceExcellent knowledge of international regulations (ICH, EU GVP Modules, UK guidelines, FDA) Experience in PV Medical writing and Project management skills Demonstrated ability to accurately and effectively evaluate, interpret and present safety data and to interpret and apply global safety regulationsDemonstrated ability to implement PV strategies and develop PV systems and procedures Professional level in English, both in oral and written communicationsDemonstrate strong leadership and collaboration skills by effectively leading and aligning cross-functional teamsAdvanced decision-making and problem-solving skillsStrong communication and leadership skillsBenefitsProfessional growth and career opportunities International team and environmentBonus based on annual performancePersonal accident and business trip insurance Additional health insuranceRemote/home-based positionRewarding referral policyWorkplace establishment allowanceTeam building, global meetings, B active events

Join our Pharmacovigilance team as Associate Director International PV.

Associate Director International PV is responsible for the leadership and oversight of the international PV office, ensuring compliance with international regulations, guidelines and internal quality standards, and alignment with the QPPV office strategy and governance. The role oversees and manages a team of EU/UK QPPVs and PV personnel and may additionally overtake EU/UK QPPVs role. The role supports the operational, financial, and client objectives of the sub-department, driving process excellence and effective management of PV operational activities.

Role is open for candidates in any EU country. All CVs must be submitted in the English language for consideration.

Responsibilities:

• Management of Full Pharmacovigilance systems and projects (or part of them) and ensure oversight of the full PV system
• Support execution of the QPPV Office strategy, oversee strategic/key accounts. Maintain and improve the functioning and efficiency of the QPPV office
• Influence the performance of the quality system and PV activities and drive quality improvements and process harmonization across regions
• Oversee sub department forecasting and contribute to budget planning ensuring efficient functioning of the QPPV Office. Support with pharmacovigilance RFI and RFP documents
• Support the maintenance of the Pharmacovigilance System Master File (PSMF) and oversight of local annexes and related governance documentation
• Manage PV projects and customer activities, supervising core PV deliverables. Overseeing PSURs, RMPs, literature monitoring, SOP updating, safety information handling and signal management
• Ensure oversight of the contractual partner safety data exchange agreements
• Oversee inspection/audit strategy, readiness, and finding remediation
• Monitor regulatory changes and ensure PV compliance (legal, procedural, and contractual) across assigned projects, by reporting non-compliance promptly. Act as subject matter expert for PV in assigned company processes
• Manage assigned team (regional QPPVs), including setting goals, evaluating performance, and supporting decisions on promotions, compensation review, and competence development
• Oversee resource planning and allocation, including identifying staffing needs and participating in recruitment
• May Act as the Project Manager or deputy Project Manager for the assigned projects in accordance with a separate Job Description (if applicable)
• May act as the appointed EU/UK QPPV or deputy EU/UK QPPV in accordance with a separate QPPV Job Description (if applicable)
• Identify areas for improvement and proactively propose solutions within the area of responsibility
• Perform additional tasks related to the department’s activities in the absence of another employee or staff member of the same department

Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree
• At least 6 years of work experience in PV functions and 1 year of experience in managing PV teams
• Team management experience
• Excellent knowledge of international regulations (ICH, EU GVP Modules, UK guidelines, FDA)
• Experience in PV Medical writing and Project management skills
• Demonstrated ability to accurately and effectively evaluate, interpret and present safety data and to interpret and apply global safety regulations
• Demonstrated ability to implement PV strategies and develop PV systems and procedures
• Professional level in English, both in oral and written communications
• Demonstrate strong leadership and collaboration skills by effectively leading and aligning cross-functional teams
• Advanced decision-making and problem-solving skills
• Strong communication and leadership skills

Benefits

• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home-based position
• Rewarding referral policy
• Workplace establishment allowance
• Team building, global meetings, B active events

Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.

Biomapas is a functional and full outsourcing solution provider to the global life science industry.

As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle.

Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.