Senior Associate Drug Safety job in Maidenhead, England

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Pharmacovigilance

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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.