Remote Senior Specialist, Regulatory & PV Network

Description:

• The Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and driving regulatory and pharmacovigilance (PV) deliverables based on an established PV and regulatory plan.
• This role serves as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and/or consultants in the planning, organizing, and preparing of regulatory deliverables.
• The Senior Specialist will act as the Local Contact Person for Pharmacovigilance for the designated country.
• Responsibilities include leading projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables, and driving the team to meet agreed targets.
• The role involves developing strategy and managing setup activities with the help of a senior team member, providing strategic input to customers, and addressing any risks by implementing preventive measures.
• The Senior Specialist will collect, review, track, and maintain Local Contact Persons' (LCPs) CVs, job descriptions, training records, and monthly reports.
• Ensuring correct training assignment and compliance by LCPs is also a key responsibility.
• The position requires monitoring project budgets and hours spent versus budgeted, providing support to proposal development, and preparing client invoices.
• The Senior Specialist will provide training, coaching, and mentoring to junior staff and foster professional relationships with internal and external contacts.
• Staying updated on changing regulatory requirements and maintaining the regulatory intelligence database is essential.
• Participation in audits/inspections and tracking LCPs' key performance indicators are also part of the role.

Requirements:

• A Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience is required.
• Strong experience within the pharmaceutical or CRO industry or a regulatory body is necessary.
• Good knowledge of ICH GCP and/or GVP and national regulations for relevant territories is essential.
• PV training and/or working experience, along with other educational or professional background as required locally, is needed.
• Fluency in English, both written and verbal, is mandatory.
• Proficiency in the official language of the country of residence is essential for local interactions and compliance.
• Proficiency in German, French, or Italian is a plus but not mandatory.
• Good planning and organizational skills are required.
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment are necessary.
• Attention to detail is crucial for this position.

Benefits:

• PrimeVigilance offers training and career development opportunities internally.
• There is a strong emphasis on personal and professional growth within the company.
• Employees can expect a friendly and supportive working environment.
• The opportunity to work with colleagues from around the world, with English as the company language, is provided.