Associate Pharmacovigilance Scientist

Posted 19 January by AstraZeneca Featured

Associate Pharmacovigilance Scientist

Location, Cambridge

Salary, Competitive

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.

Essential skills:

  • 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

Reference: 33494436

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