Senior Associate Drug Safety

Highly Competitive
  1. Contract
  2. Pharmacovigilance
  3. United Kingdom
Maidenhead, England
Posting date: 08 Jul 2024
61299

Proclinical is seeking a dedicated Senior Associate for Drug Safety. This role primarily supports the Senior Drug Safety Manager for Nordics/Baltics in managing local Pharmacovigilance (PV) tasks in compliance with local regulations and global business requirements. As a member of the International Pharmacovigilance (IPV) group, the Senior Associate will also facilitate the implementation and ongoing management of the overarching Pharmacovigilance strategy and operations.

Key Responsibilities

  • Maintain awareness of all Organised Data Collection Programs (ODCPs), Extended Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities relevant to the Nordics/Baltics region.
  • Author and maintain PV-related training and ensure compliance and regular delivery to all affiliate staff, PV operations vendors and service providers.
  • Author local documents, such as Standard Operating Procedures (SOPs), literature screening strategy, and ensure content alignment with global procedures and local PV requirements.
  • Contribute to PV oversight, compliance management, and assist with late case investigations.
  • Maintain a constant state of inspection readiness by maintaining appropriate documentation/evidence.
  • Contribute to the continuity of the critical PV activities in the Nordics/Baltics.
  • Support the safety activities needed for launch and oversight of Skyclarys, Biogen Biosimilars and any other products as needed.
  • Support data gathering for PSMF updates under the remit of IPV.
  • Support the oversight of training compliance as it pertains to vendors using the Brainshark system.
  • Assist with monthly reports on PV metrics.

Requirements

  • In-depth knowledge of Global, Regional, and local PV regulations and requirements.
  • Excellent written and verbal communication skills.
  • Well-developed technical writing skills.
  • Proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
  • Ability to work effectively/collaboratively in a fast-paced and matrixed environment.
  • Strong decision-making skills.
  • Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
  • 1-3 years in drug safety/pharmacovigilance in pharmaceutical industry setting.
  • Experience with interacting with third parties (e.g. PV operations vendors) required.
  • Knowledge of Good PV Practices.
  • Experience with Adverse Events Intake systems.
  • Experience in writing procedures, training materials, and effectively delivering training to a diverse audience.
  • Proficiency in English if not native language and local language.

If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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