Manager Medical Safety (Remote)

The Manager, Medical Safety is a key member of the Medical Safety team within Global Regulatory and Drug Safety (GRADS) department. In close collaboration with Safety Physician(s), senior Medical Safety Scientists, and other stakeholders, responsibilities include supporting signal management activities, preparation of aggregate safety reports (eg., PBRERs, DSURs, PADERs), supporting the safety evaluation and risk management of assigned products, and representation of Medical Safety within the company (eg., supporting safety management team activities, supporting clinical development activities).

• Applies professional/technical expertise in preparation of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant safety sections.
• In conjunction with Safety Physician, supports signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns and helps produce accurate and fit for purpose evaluation documents with clear conclusions.
• Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners/other departments. Assists with preparing meeting materials.
• In conjunction with Safety Physician, collaborates with project team/cross-functional teams on the production/update of risk management plans (RMPs) and other relevant safety reports/contributions.
• In conjunction with Safety Physician, supports PV contributions to global regulatory submissions for new products, formulations, or indications.
• May provide safety input into creation or review of Safety Data Exchange Agreements, and other documents requiring input from Medical Safety Scientist.
• May be responsible and/or serve as business process owner for relevant projects, improvement initiatives, and/or procedural documents.
• Supports in internal audits and Health Authority inspections, as required.

Minimum Requirements

• At least 2 years of experience in PV function. Experience in surveillance, clinical safety, aggregate safety reporting and/or risk management PV functions is highly preferred.
• Working knowledge of PV regulations regarding aggregate safety reports, signal management, and risk management.
• Proficiency in medical writing, communication, and planning/organizational skills
• Knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases.
• Proficiency with Windows applications, and ability to learn new programs / databases.

• Requires a degree (e.g., BS, BA, MSc, PharmD or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.