About the job
As a Senior Specialist in Regulatory Affairs and Pharmacovigilance at PrimeVigilance, you will be pivotal in shaping our regulatory strategies by adhering to evolving regulatory requirements. Your role will involve orchestrating regulatory and pharmacovigilance (PV) deliverables according to a meticulously crafted PV and regulatory plan. You will act as a key liaison among regulatory and functional teams, including external partners, clients, authorities, and consultants, ensuring seamless preparation and organization of regulatory deliverables that align with both corporate goals and industry standards.
You will also serve as the Local Contact Person for Pharmacovigilance within your designated country, leading initiatives that uphold the highest standards of compliance and efficiency.
Key Responsibilities:
- Function as the Local Contact Person for Pharmacovigilance activities in your country.
- Lead and represent complex projects, ensuring effective coordination of regulatory deliverables and adherence to established procedures.
- Collaborate with senior team members to formulate robust strategies and oversee setup activities, including project management plans and core documentation.
- Provide strategic guidance to both internal and external stakeholders, proactively identifying and mitigating risks.
- Resolve performance issues and support the team in achieving satisfactory resolutions.
- Maintain and track the qualifications and training records of Local Contact Persons (LCPs).
- Oversee project budgets and ensure timely escalation of any discrepancies.
- Contribute to proposal development, budget input, and represent the department in business development meetings.
- Prepare and approve client and vendor invoices.
- Mentor junior staff and foster collaborative working relationships with both internal teams and external contacts.
- Stay updated on regulatory requirements and maintain a comprehensive regulatory intelligence database.
- Support audits and inspections, representing the department as necessary.
- Track key performance indicators for LCPs and compile monthly reports.
- Provide feedback on vendor performance to inform assessments.
- Engage in department initiatives and contribute to the development of standard operating procedures.

