Senor Drug Safety Manager

Highly Competitive
  1. Permanent
  2. PV Manager, Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Maidenhead, Berkshire
Posting date: 13 Jun 2019
DS.DM.23832_1560417524

An internationally known biotechnology company has an opening for a position as a Senior Drug Safety Manager at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.

The Senior Manager - Drug Safety will serve as a product lead for Pharmacovigilance activities within the company's Medical function. The Senior PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

Job Responsibilities:

  • Leading the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
  • Synthesising data from multiple sources and authoring signal evaluation reports.
  • Leading signalling review process and product Safety Signalling Team meetings.
  • Managing literature review for safety information.
  • Collaborating with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests, and other product activities, as assigned.
  • Leading the process for responding to safety questions from regulatory authorities.
  • Contributing to and leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management, and responding to ad hoc safety questions.
  • Leading and collaborating with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

Skills and Requirements:

  • Degree in a relevant field.
  • Experience with Drug Safety
  • Demonstrated project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 0203 814 1315 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

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

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