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Drug Product Safety Specialist

  • Job reference: 931457
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 22/07/2020

Orion Group Life Sciences have an exciting opportunity for a Drug/Product Safety Specialist with our Multinational Pharmaceutical client based in the Berkshire area on an initial 4-month contract with potential to be extended.


Job Purpose
Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.

Main Responsibilities of the role

Inbound Case Management:

Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company

  • Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
  • Provision of safety information/acknowledgement to marketing partners/other third partypartners/Global Medical Safety within the internal and contractual timelines
  • Requesting additional information from multiple sources, both internal and external to the Company
  • Assist with assessment of incoming information from multiple sources, both internal and external to the Company
  • Assist in the quality review of data captured in the Global Safety Database

Outbound Case Management:

  • Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and Notified Bodies (British Standards Institution (BSI))
  • Quality review of expedited assessments prior to submission
  • Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines

Additional Activities

  • Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
  • Support all occurrences of internal and external audits and inspections
  • Ensures all assigned training is completed in a timely manner
  • May be involved in mentoring/training of Janssen staff and/or third party partners with respect to pharmacovigilance
  • May be involved in completion of periodic reconciliation activities
  • May be assigned as key contact for studies or partner contracts
  • Support CSTL / LSO in responding to ad hoc requests as required



    Desired Experience and Background of the successful candidate
  • Awareness of and familiarity with industry principles of drug development and pharmacology
  • Proficiency in global and local SOPs
  • Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s)
  • Ability to prioritise and work to strict timelines on a daily basis
  • Excellent verbal and written communication skills
  • Ability to negotiate and communicate with internal and external customers
  • Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
  • Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland

Experience

  • Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable

Education

Degree-level qualification (ideally in life science) or equivalent qualification

For more information on this role, call Ian Towler on +44 (0) +44 2039944701 or email Ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 931457


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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