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Drug/Product Safety Specialist

  • Job reference: 931439
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 21/07/2020

Orion Group Life Sciences are looking for a Local Medical Safety Scientist for our Multinational Pharmaceutical client based in the Buckinghamshire area on an initial 12 month contract with the potential to extend.

Job Purpose

Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.

Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.

Main Responsibilities of the role

Benefit Risk Management

  • Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Local Safety Officer (LSO) if applicable
  • Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate;
  • Provide Risk Management Plan status updates;
  • Prepare Local RMPs/ Addendums etc (if performed by IPV);
  • Involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required;
  • Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety as required;
  • Involvement in DHPCs management, submit and track DHPCs to RAs (Regulatory Authority)/HCPs (if performed by IPV);
  • Involvement in local safety signal detection, if applicable;
  • Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations;
  • Perform concept and protocol review related to data generation activities - clinical and post-authorization studies (for Pharma in RECAP) and Local Safety Monitoring Plan (SMP);
  • Provide support to HUB for local RRA;
  • Medical/ pharmaceutical assessment of local individual cases when requested in partnership with global teams if applicable;
  • Undertake appropriate actions such as site visits for special interest cases as requested by LSO;
  • Support to implement CCDS into local label (SmPC, patient Leaflet etc) when required;

Other Responsibilities:

  • Aggregate reports
  • PV-Safety training support
  • PV contract management
  • Safety regulations
  • Local Communications
  • Local Safety compliance (PV and non-medicinal product safety
  • Pharmacovigilance and Vigilance Service Provision

Desired Experience:

  • 3-5 years
  • Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages).

  • Basic knowledge of GMS database systems.

  • Awareness of and familiarity with industry principles of drug development and pharmacology

  • Proficiency in global and local SOPs

  • Ability to negotiate and communicate with internal and external customers.

  • Ability to establish and maintain open relationships within the organisation and with authorities.

  • Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.

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For more information on this role, call George on +44 (0) 203994470 or email for a completely confidential chat about this role and other opportunities.

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.