Associate Director, Pharmacovigilance - Product Safety

Title: Associate Director, Pharmacovigilance/ Product Safety Location: Remote - reputed company Full time job reputed company R3538 Job reputed company: At reputed company, every reputed company and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the reputed company experience, celebrates curiosity, and values every person's contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great reputed company to Work in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK. For patients, for reputed company other, and for the reputed company of science, we're in. Are you? About the Role: We're looking for an Associate Director, Pharmacovigilance/ Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you'll reputed company medical expertise regarding the safety and risk assessment of reputed company products at reputed company stages of the product life cycle (clinical to post-marketing). This individual will ensure that the safety data are evaluated medically and put in context thus underpinning risk management initiatives. This individual will have responsibility for medical assessment and medical review activities and may contribute to safety sections of safety and non-safety documents. What You'll Do: In this role, you'll have reputed company to reputed company medical reputed company and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives reputed company by vendors or reputed company. You'll also:

• Compile analysis of similar events (AOSE), individual case comments, RMP analyses, and reputed company safety analyses as required by health authorities or corporate policy.
• reputed company medical input for maintaining RMP and post-marketing safety monitoring commitments
• reputed company periodic benefit-risk assessment reports for internal use
• Investigate and review emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other reputed company
• Author, review and reputed company input and approval for drug-safety reputed company regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated reputed company of Safety (ISS), Integrated reputed company of Efficacy (ISE), MedDRA coding of reputed company, product package and labeling
• Interacts with drug safety vendor for medical review and safety assessment activities
• Be an reputed company member in internal safety review committee meetings

Who You Are: You have either a Masters degree in life sciences, an RN, PharmD or MD along with 3-5 years minimum experience in the role of safety officer or similar pharmacovigilance leadership role in the pharmaceutical industry. You are or you also have:

• Device experience strongly preferred
• Strong skills in the management of safety information originating from both clinical development and post-marketing sources
• Expert knowledge of the regulations governing pharmacovigilance
• Working knowledge of industry reputed company pharmacovigilance databases and MedDRA
• Strong Leadership skills and ability to communicate with individuals at reputed company reputed company (administrative to key thought leaders)
• Excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, reputed company, accuracy and conciseness.

Where You'll Work This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events will be expected. Travel Requirements Minimal travel expected - up to 10% annually. #LI-TB1 #LI-Remote Pay reputed company: $179,000.00-232,500.00 Annual Life at reputed company At reputed company, you'll reputed company a culture as reputed company as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP)
• Generous reputed company time off policies, fertility and family-forming benefits, caregi

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