- £25,000-£30,000 per annum
- Contract Type:
- Kent, England
- DAR 0283
- Contract Type:
Job Title: Pharmacovigilance Officer
Salary: £25,000-£30,000 per annum
Swanstaff Recruitment is an award winning agency working on behalf of its prestigious client in pharmaceutical sector who is currently looking for a highly skilled and organised Pharmacovigilance Officer.This exciting and unique opportunity is a full time permanent role.
To represent PSRM in negotiating and executing regional Pharmacovigilance Agreements (PVAs) with partner companies for licensed, acquired, divested, or co-developed products. To maintain an electronic database of global and local PVAs.
- Reviews contractual business agreements (“Main Agreements”) and determines whether inclusion of Pharmacovigilance language is required or the setup of a distinct PVA is needed.
- Negotiates regional PVAs with Business Partner and ensures that all relevant changes to the standard text will be approved by the responsible functions at PSRM and the Legal Department
- Advises local affiliates with the negotiation of local PVAs
- Liaises with relevant stakeholders (e.g.Business Development, Legal Department, Affiliates, Regional Management, Regulatory Affairs) to ensure that PVAs will be established for relevant Main Agreements.
- Supports the Authors of GOPs/SOPs related to PVAs
- Maintenance of the PVA database and retrieval of information on a regular or ad hoc basis.
- Collaborates with relevant functions within PSRM functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings.
- Is responsible for distribution, communication and documentation of PVAs and other contract relevant documents at GVP
- Maintains PVA s up to date (e.g., changes to the Main Agreement or changes to applicable guidelines, contacts. product lists etc).
- Supports processes for maintenance of the Pharmacovigilance System Master File, according to Good Pharmacovigilance Practice Module II.
- Participates in projects relating to PVA business.
- Maintains inspection and audit readiness
The job holders minimum experience accountability and the scope should be:
- Accountable to Manager (Global Lead Contracts Mylan PSRM) Pharmacovigilance Contracts.
- Coordinates PVA activities for PSRM, represents PSRM on routine issues and facilitates cross-functional communication.
Competence (Qualifications, Knowledge, Experience, Skills)
- Good analytical skills and the ability to organise work in a logical, thorough and succinct manner.
- Good command of the English language.
- Good negotiation skills.
- Knowledge of good documentation practice and quality management systems.
- Knowledge of worldwide PV regulatory requirements and industry best practices.
- Computer proficient (Windows, Word, Excel) and proficient in specific databases (Access).
- Flexibility to adapt to changing assignments and ability to effectively prioritize.
- Good communication skills and ability to work independently and as part of a team
Successful applicants will receive benefits package, including generous pension scheme, free car park and rewarding working environment.
Apply now or call Tom Kurczab in our Dartford branch!
EMPOWERING PEOPLE WITH OPPORTUNITIES
Swanstaff Recruitment is an equal employment company.