Senior Manager, Pharmacovigilance Operations

Highly Competitive
  1. Permanent
  2. Pharmacovigilance
  3. United States
Waltham, USA
Posting date: 13 Nov 2023

Proclinical are recruiting for a Senior Manager, Pharmacovigilance Operations to join a biotech organisation. This role is on a permanent basis and is located in the United States.


  • Accountable for enabling training, which involves training GVP modules ad pertinent US & EMA safety-linked guidance documents and processes.
  • Monitor maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from the company's clinical trials.
  • Guarantee that international clinical trials case reporting procedure is effective and compliance with reporting needs detailed within the safety management plans/PV agreements.
  • Guide the preparation of safety-linked plans with partners and CROs.
  • Offer leadership and assistance to project teams for safety-linked areas, which involves protocol development and study performance.
  • Partake in the preparation of pertinent safety sections of clinical study reports, annual reports, expedited safety reports and any other regulatory archiving documents.
  • Support the response to safety-connected questions from regulatory authorities or ethics committees if required.
  • Cooperate with others to guarantee alignment among case management, aggregate reporting, and signal actions.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in a life science, nursing, pharmacy or any other healthcare linked discipline.
  • Demonstrable experience in pharmacovigilance within a pharmaceutical organisation.
  • Familiarity with Argus Safety database.
  • Comprehension and expertise on US and ex-US pharmacovigilance regulatory needs such as US code of federal guidelines; European union GVP legislation; and ICH regulations.
  • Acquaintance with ICSR proposals would be ideal.
  • Expertise on MedDRA and WHO Drug dictionaries.
  • Prior involvement with monitoring and handling vendors.
  • Familiarity with pre- and post-approval pharmacovigilance actions, which involves safety reporting.
  • Clinical know-how and analytical skills to evaluate, review, comprehend and synthesise clinical and safety data.
  • Communication skills both verbally and in writing.
  • A high attention to detail with the ability to meet deadlines.
  • Works well independently with the capacity to handle prioritise.
  • Works well in a team with the ability to work on various projects concurrently.
  • Able to resolve issues.
  • Capable of working well under pressure.
  • Computer literacy.

If you are having difficulty in applying or if you have any questions, please contact Callum Mitchell at +44 203 398 6613.

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.