Safety Evaluation and Risk Manager | Pharmaceutical | Global Drug Safety

Safety Evaluation and Risk Manager | Pharmaceutical | Global Drug Safety Eligibility: This role requires a medical degree (MBBS or MD). Candidates without this qualification, including pharmacists and other healthcare professionals, will not be considered under any circumstances. This contract role sits within a Global Clinical Safety and Pharmacovigilance function, supporting signal detection, benefit risk assessment, and regulatory reporting across a portfolio of designated products. The successful candidate will work closely with product scientists, clinical development teams, and regulatory stakeholders to ensure safety obligations are met to the required standard and timelines. A medical degree (MBBS or MD) is a mandatory requirement for this role. There is no flexibility on this point. Applications from candidates without a medical degree, including pharmacists or other healthcare professionals, will not be reviewed. Responsibilities:Leads pharmacovigilance and risk management planning for designated products, including preparation of regional Risk Management Plans and benefit risk assessments for regulatory submissions.Runs routine signal detection processes using signal management tools, literature review, and database searches, evaluating outputs in partnership with senior physicians and TA Directors.Authors and coordinates periodic regulatory documents including PSURs and Annual Reports, supporting local operating companies with licence renewal documentation as required.Reviews and provides technical approval for investigator brochures, protocols, informed consents, final study reports, and data monitoring committee charters.Contributes to Safety Data Exchange Agreements and supports Safety Review Teams with data preparation, interpretation, and documentation of outcomes.Authors the safety contribution to global regulatory submissions for new products, formulations, and indications in collaboration with clinical development and regulatory functions. Key Skills and Experience:MBBS or MD qualification is mandatory. This is a non negotiable requirement. Pharmacy degrees or other clinical qualifications do not meet this criteria and candidates without a medical degree will not be shortlisted.Minimum 3 years of experience in pharmacovigilance, signal management, and safety report authoring.Hands on experience authoring PSURs and Risk Management Plans.Familiarity with signal management platforms and regulatory submission processes.Strong ability to evaluate and synthesise clinical and scientific data. Desirable Skills:Experience presenting to Global Labelling Committees or Safety Boards.Exposure to PASS oversight and Safety Review Team facilitation.Experience supporting US or international case management functions.