Koho hledáme
- Strong knowledge base of pharmacovigilance principles
- Excellent communication and interpersonal skills
- Attention to detail and ability to be flexible in order to meet daily competing priorities of the business
- Ability to independently manage projects and drive projects to completion
- Strong knowledge base of pharmacovigilance regulations
- Demonstrate leadership and proficiency managing across organizations
- BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline
- At least 2 years pharmacovigilance experience or related areas such as Clinical Risk Management, Clinical, or Regulatory
Co budeš dělat
- Contribute to and provide subject matter expertise for PV templates for business development partners, third-party vendors/suppliers, and emerging data source deals to ensure compliance with global PV regulations.
- Under the direction of the Executive Director/Director/Associate Director, Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), organizes, conducts and/or facilitates meetings with business development partners, CRO partners, third-party vendors/suppliers and internal stakeholders for the negotiation, implementation and maintenance of PV agreements, PV plans, and SMPs.
- Leads due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.
- Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements.
- Develops and maintains the necessary processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
- Creates and implements appropriate training as applicable in regard to new processes for each PV agreement.
- Provides support for inspections and audits related to Company partnerships.
- Collaborate with the system owner for the maintenance of the Business Development Lifecycle Management system.
- Participate in interdepartmental and interdivisional meetings in support of individual program reviews, input for PV requirements, and related processes.
- Collaborate inter-divisionally to ensure PV requirements are incorporated into business processes, standards, and resources.
- Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.
- Develop and support processes that facilitate achievement of GCS&PV objectives
- May support some or all of the above responsibilities and/or any other project or perform any other task deemed appropriate by management.
O pozici
The Senior Specialist, PV-PSM is responsible for management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. May be responsible for negotiation and maintenance of business partner and vendor PV agreements. May be responsible for the negotiation of safety management plans (SMPs) with Company CRO partners and PV Plans.