Safety Surveillance Associate

4 weeks ago

Makati City, National Capital Region, Philippines Pfizer Full time
**SAFETY SURVEILLANCE ASSOCIATE** Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. **Position purpose** Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements. **Responsibilities** Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.Consistently apply regulatory requirements and Pfizer policies. **Qualifications** Ability, with supervision, to solve routine problems and to surface issues constructively. Ability to make basic decisions with an understanding of the consequences. **Technical Skill Requirements** Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Ability to achieve personal objectives while meeting departmental standards of performance. Ability to work under supervision in a matrix organization. Excellent oral and written communication skills. Fluency in spoken and written English; knowledge of additional language(s) an advantage. Experience and skill with medical writing an advantage.
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