Senior Specialist, Regulatory & PV Network

This is a fully remote position, open to applicants in Romania.

📋 Description

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

• Take charge of leadership and functional representation for medium to high complexity projects, ensuring effective and swift coordination as well as management of regulatory deliverables.

• Collaborate with a senior team member to devise strategies and oversee setup activities.

• Offer strategic insights to both internal and external clients while swiftly identifying and addressing any risks or potential risks.

• Resolve issues and support the attainment of satisfactory outcomes for performance challenges or delivery shortcomings.

• Gather, review, track, and maintain the CVs, job descriptions, training records, contact information, and monthly reports of Local Contact Persons (LCPs).

• Ensure appropriate training assignments and compliance among the LCPs.

• Confirm that all team members engaged in departmental deliverables for the project are aware of their specific tasks and time commitments.

• Assist in the development of proposals and contribute to budget planning.

• Prepare client invoices and review or approve vendor project invoices.

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

• Cultivate professional relationships with both internal and external stakeholders at local and international levels.

• Stay informed about evolving regulatory legislative requirements.

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

⛳️ Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.

• Extensive experience in the pharmaceutical or CRO industry, or with a regulatory body.

• Solid understanding of ICH GCP and/or GVP along with national regulations relevant to areas of expertise.

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

• Proficient in English, both written and spoken.

• Candidates must be fluent in the official language of their respective country, as this is crucial for local interactions and compliance.

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

• Strong planning and organizational capabilities.

• Excellent interpersonal skills in a dynamic, deadline-driven, and continually changing environment.

• Keen attention to detail.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional advancement.

• A friendly and supportive work environment.

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