A new Senior Pharmacovigilance Scientist job is now available with a CRO based in Hertfordshire.
The main purpose of this Senior Pharmacovigilance Scientist job is to provide effective drug safety guidance and support for client projects and to oversee the development and management of key accounts.
Further key responsibilities of this Senior Pharmacovigilance Scientist job will include to:
- Provide advice on EU drug safety strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients.
- Lead/participate in specific projects as directed by the Director of Drug Safety.
- Participate in client meetings and liaise with clients regarding ongoing projects.
- Assist with establishing clients’ pharmacovigilance systems including SOPs.
- Manage and support, as required, drug safety activities including SAE case entry, regulatory assessment of SAEs and submission to relevant Authorities.
- Preparation, coordination and review of key drug-safety related regulatory documents for both investigational and marketed products, including the ASR, EU-RMP, PV Plan and PSUR.
- Ensure compliance with EU regulatory requirements including contribution to client and/or company quality systems.
- Provide input into clinical, regulatory and other services provided.
The ideal candidate for this Senior Pharmacovigilance Scientist job will be educated to a minimum degree level in a Life Sciences discipline and in addition will hold the following experience and qualifications:
- Broad experience of EU drug safety regulation that could include early-and late-phase development.
- Experience of using drug safety databases, including Eudravigilance, would be a distinct advantage.
- Training and/or post-graduate qualification in Drug Safety and/or Regulatory Affairs<p>
- Proven industry experience in a drug safety and regulatory environment, with good commercial awareness.
The successful candidate of this Senior Pharmcovigilance Scientist job will enjoy all the benefits of working with a global pharmaceutical company, including a competitive salary, holidays and career progression.
For more information, or to apply for this Senior Pharmacovigilance Scientist job, please contact Hendre at CK Clinical on: +44 (0)1438 870 023 or email firstname.lastname@example.org quoting 19712 to indicate your interest in this Senior Pharmacovigilance Scientist job.
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