Senior Associate Drug Safety

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.