Act as Local Contact Person for Pharmacovigilance for the designated country
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
With the help of a senior member of the team, develop strategy and manage set up activities
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk
Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
Ensure correct training assignment to and training compliance by the LCPs
Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
Provide support to proposal development and input to budgets
Prepare client’s invoices and review/approve vendors’ project invoices
Provide training, coaching and mentoring to junior members of staff
Foster professional working relationships with internal and external contacts at the local and international levels
Stay abreast of changing regulatory legislative requirements
Track LCPs' key performance indicators and prepare monthly summary reports

Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
Strong experience within pharmaceutical or CRO industry or Regulatory body
Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
PV training and/or working experience and other educational or professional background as required locally
Fluent in English, both written and verbal
Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
Proficiency in German, French, or Italian is a plus but not mandatory
Good planning and organizational skills
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Good attention to detail

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

Senior Specialist, Regulatory & PV Network

Key skills