Senior Specialist, Regulatory & PV Network

📋 Description

• Serve as the Local Contact Person for Pharmacovigilance in the assigned country.

• Take charge and provide functional representation for medium to high complexity projects, ensuring effective coordination and management of regulatory deliverables while driving the team to achieve the established targets and adhere to agreed procedures, trackers, and templates.

• Collaborate with a senior team member to devise strategies and oversee setup activities (including Project Management Plans, joint operating procedures, POAs, and core documents).

• Offer strategic insights to both internal and external clients, swiftly identifying and addressing any risks or potential risks by implementing preventive measures.

• Troubleshoot and assist in achieving satisfactory resolutions to performance issues or delivery failures.

• Gather, review, track, and maintain CVs, job descriptions, training records, contact details, and monthly reports for LCPs.

• Ensure appropriate training assignments and compliance for LCPs.

• Make sure all team members involved in the project for departmental deliverables are aware of their tasks and time allocations, monitor project budgets and hours spent versus budgeted, and promptly identify and escalate any Out-of-Scope (OoS) issues.

• Support proposal development and contribute to budget discussions, representing the department in Business Development meetings as necessary.

• Prepare client invoices and review/approve project invoices from vendors.

• Provide training, coaching, and mentoring to junior staff members.

• Cultivate professional relationships with internal and external contacts at both local and international levels to ensure seamless and efficient service delivery.

• Stay updated on evolving regulatory legislative requirements and maintain the regulatory intelligence database, ensuring timely dissemination of relevant changes.

• Engage in and/or assist junior members in preparing for audits and inspections, representing the department for assigned projects as required.

• Monitor LCPs' key performance indicators and compile monthly summary reports.

• Provide feedback on vendor performance to support their evaluation.

• Contribute to departmental and company initiatives, and assist in the design or review of SOPs, working practices, and guidance documents.

⛳️ Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or a related field.

• Extensive experience in the pharmaceutical or CRO industry or regulatory bodies.

• Strong understanding of ICH GCP and/or GVP as well as national regulations for relevant territories.

• PV training and/or relevant work experience, along with other educational or professional qualifications as locally required.

• Proficient in English, both written and spoken.

• Candidates must be fluent in the official language of the country where they are based, as it is critical for local interactions and compliance.

• Proficiency in German, French, or Italian is advantageous but not a requirement.

• Excellent planning and organizational skills.

• Strong interpersonal abilities in a dynamic, deadline-driven, and evolving environment.

• Attentive to detail.

🏝️ Benefits

• Opportunities for training and career advancement within the organization.

• A strong focus on personal and professional development.

• A friendly and supportive workplace culture.

• The chance to collaborate with colleagues from around the globe, with English as the primary language of the company.