Pharmacovigilance Scientist

13 Nov 2017
15 Nov 2017
Contract Type
Full Time
Kelly Scientific are working with a leading pharmaceutical who are looking for a Pharmacovigilance Scientist to join their team in London on an initial 6 months contract (with potential for further extension). The successful candidate will be providing therapeutic area PV support for assigned developmental and/or marketed products.

Further Responsibilities:
- Contribute to signal evaluation/safety monitoring activities
- Assist in usual pharmacovigilance activities including benefit/risk and regulatory activities and interactions
- Knowledge and understanding of designated products/studies.
- Review and provide PV therapeutic area input for development of protocols and other relevant project/study documents
-Participate in evaluation of safety issues in conjunction with PV Scientists
- Participate in writing (under supervision) of aggregate safety reports, e.g., PSURs; DSURs.
- Participate in writing (under supervision) of PV input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with PV physicians and other GST members.
- Assist in writing and/or reviewing of monthly safety signal reports
- In conjunction with pharmacovigilance scientists and physicians contribute to writing and maintaining Risk Management Plans.
- Participate in Global Safety Teams, including coordinating all aspects of signal evaluation/safety review activities.
- Assist with writing and maintenance of the Safety Monitoring Plan
- Contribute to safety summaries to support changes to the PI/SmPC, Type II variations including drafting justification documents
- Liaise with marketing team(s) to evaluate safety impact and provide input into program design (e.g., social media, market research, patient support programs).
- Flexible outside of primary therapeutic area as directed by departmental and business needs

- Degree in life sciences preferred
- Proven experience (2 years+) in healthcare, clinical or pharmacovigilance related environment.
- High level of proficiency in computer literacy with Microsoft applications.
- Excellent self-motivated and self-directed organizational and prioritization ability
- Excellent written and oral communication skills with willingness to quickly learn key presentational skills.
- Team player.

Kelly Services are acting as an Employment Business in regards to this vacancy.