The Pharmacovigilance Officer will be responsible for monitoring, assessing, and reporting adverse drug reactions (ADRs) and other safety issues related to drug products. This role is crucial in ensuring compliance with regulatory requirements and helping to minimize risks associated with pharmaceutical products. The successful candidate will collaborate with cross-functional teams and contribute to our commitment to patient safety.

Key Responsibilities:

Adverse Event Reporting:
- Collect, assess, and document adverse event reports from various sources.
- Evaluate the seriousness and expectedness of adverse events in accordance with regulatory guidelines.
Signal Detection and Risk Management:
- Analyze safety data to identify trends, potential safety signals, and areas of concern.
- Support the development and implementation of risk management plans.
Regulatory Compliance:
- Ensure compliance with local and international pharmacovigilance regulations and guidelines.
- Prepare and submit regulatory reports to health authorities as required.
Cross-Functional Collaboration:
- Work closely with clinical, regulatory, and quality assurance teams to ensure timely communication of safety information.
- Participate in safety meetings and provide input on risk-benefit assessments.
Documentation and Record Keeping:
- Maintain accurate and up-to-date records of all safety-related documentation.
- Ensure data integrity and adherence to company procedures and regulatory requirements.
Training and Education:
- Provide training and guidance to staff on pharmacovigilance processes and regulations.
- Stay informed about industry trends, guidelines, and best practices in pharmacovigilance.

Qualifications:

Education:
- Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or a related field. A Master’s degree or relevant certification is an added advantage.
Experience:
- Minimum 2 years of experience in pharmacovigilance or drug safety within the pharmaceutical or healthcare industry.
- Familiarity with regulatory requirements (FDA, EMA, ICH) is essential.
Skills:
- Strong analytical and critical thinking skills.
- Excellent verbal and written communication skills.
- Detail-oriented with strong organizational abilities.
- Proficient in data management and statistical analysis software.
Personal Attributes:
- A commitment to ethics and integrity in all aspects of work.
- Ability to work independently and collaboratively in a team environment.
- Strong problem-solving skills and the ability to handle multiple priorities.