Job Title:
Manager/Senior Manager - Pharmacovigilance
Location:
Gurgaon, Haryana, India (Oversees India, Bangladesh, Nepal, Sri Lanka)
Company:
Lilly
Job Description:
The Manager/Senior Manager - Pharmacovigilance will oversee pharmacovigilance activities across multiple regions (India, Bangladesh, Nepal, and Sri Lanka). This includes ensuring compliance with regulatory requirements, managing safety data, leading a team, and maintaining the highest standards of drug safety. The candidate will develop processes, assess adverse drug reactions (ADRs), and manage risk assessments.
Key Responsibilities:
Pharmacovigilance Management:
Oversee compliance with local and international pharmacovigilance regulations.
Collect, assess, and report adverse drug reactions (ADRs) and other safety data.
Develop and implement pharmacovigilance processes and procedures.
Leadership:
Lead and mentor a team of pharmacovigilance professionals.
Collaborate with cross-functional teams such as clinical, regulatory, and quality assurance.
Reporting and Risk Management:
Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents.
Conduct risk assessments and develop risk management plans.
Regulatory Liaison:
Liaise with regulatory authorities and external stakeholders as necessary.
Stay updated on the latest pharmacovigilance regulations and guidelines.
Required Qualifications:
Education:
Bachelor’s degree in Pharmacy, Medicine, or a related field (Advanced degree preferred).
Experience:
5-7 years of experience in pharmacovigilance, with at least 2 years in a managerial role.
In-depth knowledge of pharmacovigilance regulations and guidelines for India, Bangladesh, Nepal, and Sri Lanka.
Skills:
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Proficiency in pharmacovigilance databases and software.
Ability to work in a multicultural environment.
Preferred Skills:
Experience handling pharmacovigilance activities for multiple countries.
Certification in pharmacovigilance or related fields.
Strong analytical and problem-solving skills.
Ability to manage multiple projects and deadlines.
Benefits:
Competitive salary and benefits package.
Opportunities for professional growth and development.
Collaborative and inclusive work environment.
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