Global Director of Product Safety Management
Job details
Responsibilities:
Lead and supervise a team responsible for the major international and high-profile Elanco product portfolio, ensuring alignment with Elanco Pharmacovigilance goals and delivery of essential wins, while collaborating cross-functionally.
Act as the primary point of contact and escalation for all Product Safety concerns worldwide, ensuring regulatory defense of the portfolio and integrity of safety data, while partnering with cross-functional teams.
Coordinate team resources to ensure business continuity and regulatory compliance, fostering a culture of Psychological Safety and professional development in collaboration with cross-functional partners.
Support and lead key Pharmacovigilance projects, collaborating cross-functionally as required, and ensuring compliance with company policies and global regulations, while working closely with internal and external stakeholders.
Deliver technical pharmacovigilance training and support to internal and external stakeholders, including coaching peers and collaborating with the PV Lead Team to ensure pharmacovigilance compliance.
Represent Elanco in internal and external pharmacovigilance inspections, reviewing, analyzing, and interpreting data to identify safety trends and signals for risk mitigation recommendations.
Enhance "data first" mindset and provide scientific/statistical interpretation of PV data to internal business partners, ensuring an accurate representation of the data collection and analysis process, and prepare and present aggregate data to global regulatory authorities.
Interpret PV requirements for Elanco and contract personnel, contribute to PV projects to drive safety information updates for marketed products, and lead the technical review and interpretation of scientific data for assigned products.
Collaborate with cross-functional teams on new product development and global marketing initiatives, while performing any other duties or projects requested by the line manager at the appropriate grade and level of responsibility.
What You Need to Succeed (minimum qualifications):
Education: Doctor of Veterinary Medicine or Bachelor's Degree or higher in biological sciences.
Required Experience: A minimum of 8 years of experience in pharmacovigilance or related field.
Top 2 skills: Strategic Leadership and previous experience in a Pharmacovigilance role.
What will give you a competitive edge (preferred qualifications):
Previous experience in regulatory compliance and signal detection.
Strong communication and stakeholder management skills.
Additional Information:
Travel: Minimal travel required annually.
Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment.
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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