9 days old

Global Safety Lead - Pharmacovigilance

Mississauga, ON L5B
  • Job Code

Essential Qualification:

  • MBBS/MD- Bachelor of medicine and bachelor of surgery/Doctor of Medicine

  • Extensive experience in Pharmacovigilance Safety Surveillance.

Essential skills:

  • Good knowledge of medical review of ICSR and PSUR

  • Good understanding of ICH-GCP guidelines

  • Writing skills in medical and scientific documents

  • Sound Medical judgment

Reporting To: Delivery Manager/ Operations Manager/ Delivery Director

Key Operational Responsibilities:

  • Perform Medical Review of assigned ICSR and PSUR.

  • Assist the Brand Safety Teams in monitoring the safety profile of products potentially including activities such as literature review, evaluation of individual cases or signal detection.

  • Detect, analyze, assess and escalate safety signals on identified products.

  • Perform medical review of signals identified.

  • Contribute to Signal Detection Board and Medical Safety Review Board (MSRB) meetings including preparatory activities.

  • Together with the Brand Safety Teams, co-author the PSUR (Periodic Safety Update Report) including providing analytical input for the overall scientific content, the medical safety evaluation and conclusions of the PSUR and Development Safety Update Report (DSUR).

  • With the Brand Safety Teams, assist in preparing, reviewing, approving and finalizing of the Risk Management Plan (RMP).

  • Assist in evaluating and authoring other safety deliverables including but not limited to clinical overviews, ad hoc health authority queries, development Safety Profiling Plan (dSPP), Development Safety Update Report (DSUR).

  • Support safety input to Drug Regulatory Authority (DRA) and clinical documents (e.g. core data sheet and investigator brochure (IB).

  • Contribute to Safety Management Team (SMT) including preparatory activities and Safety Project Team (SPT) meetings.

  • Support the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events.

  • Conform to established productivity metrics

  • Quality metrics as per client feedback on the activity performed. Timelines- Timelines for medical safety deliverable are dependent on deliverable type and will be agreed on a case by case basis

Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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Global Safety Lead - Pharmacovigilance

Mississauga, ON L5B

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