Associate Pharmacovigilance Scientist
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.
This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. In Global Medicines Development (GMD) we have a crucial role to play. Faced with complex disease challenges, we’re focused on exceptional performance to drive the best and most transformative drug programmes ever.
The Associate Pharmacovigilance (PV) Scientist is an entry level role which supports the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents to identify and escalate potential safety issues. He/she has the ability to provide the first draft of safety documents and regulatory reports, and will participate in meetings, as necessary.
Responsibilities will include:
You will support proactive pharmacovigilance and risk management planning for designated
products, including project managing preparation of the safety aspects of the global Risk
Management Plans, in partnership with the Global Safety Physician (GSP) and
(Senior/Principal) PV Scientist, as appropriate.
Providing patient safety input to pivotal study documents, for example Investigator
Brochures, Protocols, Informed Consents and Clinical Study Reports. You will run/supportss routine signal detection processes in partnership with the GSP, for all
products in area of responsibility.
Identify and use appropriate sources of information and database searches to retrieve
relevant data for evaluation of signals. Creates first draft of documents with clear
conclusions in response to internal or regulatory authority requests for safety data.
In consultation with the GSP and Clinical representatives, drafts the Reference Safety
Information (RSI) for assigned development products; coordinates meetings and tracks
timelines to ensure completion.
Providing input to periodic regulatory documents (e.g. PBRERs, PSURs, and DSURs)
according to the agreed processes and timelines as well as patient safety input to the global regulatory submissions for new products, formulations or indications (e.g. NDA, BLA, MAA), in partnership with GSP and (Senior/Principal) PV Scientist and in liaison with other functional experts.
Raise appropriate concerns/issues to senior staff in a timely manner.
- A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/
- Drug Development knowledge.
- Fluent in written and verbal English
- Basic awareness of Pharmacovigilance regulations
- MD, MSc/PhD in scientific discipline, preferred
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law
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