confidentialIndianapolis, IN
Vice President, Pharmacovigilance and Safety
Vice President, Pharmacovigilance and Safety
Pharmaceutical Preparation ManufacturingBiological Product ManufacturingResearch and Development in Biotechnology
Apply for this role (opens in a new tab)Vice President, Pharmacovigilance and SafetyAbout the Company Forward-thinking pharmaceutical company Industry
Pharmaceuticals Type
Privately HeldAbout the RoleThe Company is seeking a Vice President of Pharmacovigilance and Safety to spearhead the global safety strategy for its small molecule pipeline. The successful candidate will be responsible for ensuring the highest standards of patient safety and regulatory compliance, leading the safety surveillance and signal detection process, and overseeing the preparation and submission of various safety reports. This role requires a strong leader with a proven track record in pharmacovigilance, particularly in the context of small molecule drug development, and the ability to represent the company in regulatory interactions. Cross-functional collaboration is key, as the VP will work closely with clinical development, clinical operations, regulatory, medical affairs, and commercial teams to integrate safety considerations into decision-making. Applicants must have an MD in a life sciences field, with at least 15 years' of pharmacovigilance experience in the biopharmaceutical industry, including a minimum of 10 years in leadership roles. The role demands an individual with extensive experience in all phases of small molecule drug development, a strong understanding of global PV regulations, and a demonstrated ability to lead safety risk management and benefit-risk assessments. The VP will also be responsible for building and leading a high-performing pharmacovigilance team, so experience in team leadership and development is essential. The ideal candidate will have a proven ability to thrive in a dynamic, high-growth biotech environment and possess excellent communication, stakeholder management, and problem-solving skills. Functions Medical Care/Hospital Administration
Operations
Also on the board Same function, level within a rung
Level
Manager
Location
Indianapolis, IN
Occupation
Regulatory Affairs Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
32 days ago