Global Pharmacovigilance (GPV) Safety Officer (Senior Director)

Melinta Therapeutics

Morristown, New Jersey or Lincolnshire, Illinois.

Are you a Physician with an MD from an accredited and US recognized University and have significant hands-on experience in GPV leading Safety activities for pharmaceutical products both marketed and in development?

Do you want to lead Safety for a company, dedicated to providing critical care pharmaceutical products within the Infectious Disease therapeutic pathway, and to be part of building a pure-play antibiotics company?

Are you ready to lead a team, but also to be a hands-on practitioner leading by example? This is a roll-up your sleeves company where everyone supports each other.

Are you motivated by a fast-paced and evolving environment where shifting priorities require intellectual agility and superior organizational skills?

Are you experienced in monitoring of worldwide regulatory events and information for your products and those of your competitors to evaluate safety signals?

Will you act like an owner as it relates to all activities associated with product safety and pharmacovigilance, and be an ambassador for Global Safety in all interactions within the company and externally, including interaction with alliance partners and regulators?

If the answer to these questions is a resounding “yes”, then keep reading and let us know all about you.

@Orchard LLC, has been retained by a market-leader in the critical Infectious Disease therapeutic sector to add an experienced GPV Safety Officer at the Senior Director level to lead all safety activities and monitoring for current marketed products and those in development, or being acquired. This is an exceptional opportunity to both bring your current expertise and broaden your knowledge and responsibilities in a meaningful and valuable fashion. The Senior Director’s responsibilities involve every aspect of GPV from a safety perspective and require both the knowledge, and the willingness to be hands-on as a leader/practitioner. This is truly a growth opportunity working with a small team that will expand as products are added to the portfolio. Our client is backed by a leading private equity company, dedicated to creating a sector leader in the ID space with a focus upon critical care within hospital settings.

If you are interested in working for a company doing good work in the area of antibiotics, hospital care, and ID. If you are excited by a challenge and motivated to work within an environment requiring adaptability and intelligence, then is your perfect opportunity.

As the GPV Safety Officer you will;

• Scientific safety leader for assigned products and/or devices that are marketed and/or in development.
• Monitor worldwide safety information for assigned products and their competitors. Lead integration, analysis, interpretation of safety information from all sources, including preclinical through post marketing (lifecycle) and externally.
• Identify, evaluate safety signals, and lead safety issue management. Act as an owner and consider any potential impact on our client when it comes to decision making.  Know when to escalate.
• Lead cross-functional Safety Management Team for assigned projects/products and ensure required documentation of activities and decisions.
• Author, review, provide input into  safety documents and relevant sections of regulatory or clinical documents, including  aggregate safety reports, reference safety information, risk management plans, protocols, safety analyses, expert statements, submission dossiers, clinical study reports, health authority responses.
• Ensure timely release of documents that align with regulatory requirements and our client’s quality standards.
• Liaise effectively with Global Safety Scientist, client partners and vendors on pharmacovigilance and safety risk management activities for assigned projects/products.
• GPV ambassador for vision, mission, change (internal and external to our client)
• Provide support for business development activities, regulatory authority inspections,  training, and product recall as needed
• Maintain continuous awareness of evolving safety profile of competitive products as well as scientific information related to our client’s portfolio.  Stay continuously aware of evolving global PV and risk management regulations, as well as developments in PV and benefit-risk assessment science.
• Ensure activities are performed within budgets and flagged early if budgetary requirements expand.
• Continuously educate all stakeholders on pharmacovigilance and risk management requirements and science using “Right First Time” principles.

Your background will include the following education, experience and capabilities;

• MD degree and a Residency in internal medicine or other similar discipline required.
• Advanced training in epidemiology, public health, and statistics preferred.
• Clinical experience required.
• Demonstrated leadership of a PV and Safety function within a pharmaceutical company or Biotech with marketed branded products and products in development.
• Demonstrated knowledge of pharmacovigilance science, operations, and global regulations, including authoring responses to health authority requests and inspections.
• Demonstrated understanding of drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing for publications.
• Proven examples of analysis, interpretation and representation of safety information both in writing and via oral presentation to internal stakeholders, external partners and customers.
• Hands-on experience in preparing clinical safety assessments and regulatory reports/submissions, involving safety information.
• Demonstrated examples of designing the safety approach for product launches, label development and post-marketing commitments.
• Demonstrated ability to lead small teams, including people management experience, including the ability to manage a team of remote staff and integrate third-party vendors to complete assigned projects.

If this opportunity sounds like a good fit, or if you would simply like more information, please apply so that we can paint the full picture.

Established in 2010, @Orchard LLC, also known as, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.  Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.atOrchard.com.